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Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) (PANTHER)

Primary Purpose

Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Azacitidine
Pevonedistat
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Drug therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Has morphologically confirmed diagnosis of myelodysplastic syndromes (MDS) or CMML (i.e., with white blood cell [WBC] <13,000/microliter [mcL]) or low-blast acute myelogenous leukemia (AML).

  2. Has MDS or CMML and must also have one of the following Prognostic Risk Categories, based on the Revised International Prognostic Scoring System (IPSS-R):

    • Very high (>6 points).
    • High (>4.5-6 points).
    • Intermediate (>3-4.5 points): a participant determined to be in the Intermediate Prognostic Risk Category is only allowable in the setting of >=5% bone marrow myeloblasts.
  3. Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2.
  4. Participants with AML (20%-30% blasts) must have a treatment-related mortality (TRM) score >=4 for intensive, induction chemotherapy as calculated using the simplified model described by Walter and coworkers.

Calculation of TRM score:

  • 0 for (age <61 years), +2 for (age 61-70 years), +4 for (age >=71 years).
  • + 0 for (PS=0), +2 for (PS=1), +4 for (PS >1).
  • + 0 for (platelets <50), +1 for (platelets >=50).

Exclusion Criteria:

  1. Has previous treatment for HR MDS or CMML or low-blast AML with chemotherapy or other antineoplastic agents including hypomethylating agent (HMAs) such as decitabine or azacitidine. Previous treatment is permitted with hydroxyurea and with lenalidomide, except that lenalidomide may not be given within 8 weeks before the first dose of study drug.
  2. Has acute promyelocytic leukemia as diagnosed by morphologic examination of bone marrow, by fluorescent in situ hybridization or cytogenetics of peripheral blood or bone marrow, or by other accepted analysis.
  3. Participants with AML with a WBC count >50,000/mcL. Participants who are cytoreduced with leukapheresis or with hydroxyurea may be enrolled if they meet the eligibility criteria.

  4. Is eligible for intensive chemotherapy and/or allogeneic stem cell transplantation. The reason a participant is not eligible for intensive chemotherapy and/or allogeneic stem cell transplantation may consist of one or more of the following factors:

    • Age >75.
    • Comorbidities.
    • Inability to tolerate intensive chemotherapy (e.g., participants with AML with 20%-30% blasts and TRM >=4).
    • Physician decision (e.g., lack of available stem cell donor).
    • The reason a participant is not eligible should be documented in the electronic case report form (eCRF).
  5. Has either clinical evidence of or history of central nervous system involvement by AML.
  6. Has active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.
  7. Is diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease.
  8. Has nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection.
  9. Has prothrombin time (PT) or aPTT >1.5× upper limit of normal (ULN) or active uncontrolled coagulopathy or bleeding disorder. Participants therapeutically anticoagulated with warfarin, direct thrombin inhibitors, direct factor Xa inhibitors, or heparin are excluded from enrollment.
  10. Has known human immunodeficiency virus (HIV) seropositive.
  11. Has known hepatitis B surface antigen seropositive, or known or suspected active hepatitis C infection. Note: Participants who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load.
  12. Has known hepatic cirrhosis or severe preexisting hepatic impairment.
  13. Has known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure (New York Heart Association Class III or IV), and/or myocardial infarction within 6 months before first dose, or severe pulmonary hypertension.
  14. Has treatment with strong cytochrome P 3A (CYP3A) inducers within 14 days before the first dose of pevonedistat.

Sites / Locations

  • Southern Cancer Center - USOR
  • Southern Cancer Center - USOR
  • Southern Cancer Center - USOR
  • Southern Cancer Center- USOR
  • Southeastern Regional Medical Center - CTCA - PPDS
  • Arizona Oncology Associates (Orange HOPE) - USOR
  • Arizona Oncology Associates (Rudasill HOPE) - USOR
  • Arizona Oncology Associates (Wilmot HOPE) - USOR
  • Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc
  • Compassionate Cancer Care Medical Group Inc
  • UC San Diego Moores Cancer Center
  • Emad Ibrahim, MD, Inc
  • Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc
  • Rocky Mountain Cancer Centers (Aurora) - USOR
  • Rocky Mountain Cancer Centers (Boulder) - USOR
  • Rocky Mountain Cancer Centers (Colorado Springs) - USOR
  • Quest Diagnostics, INC
  • Colorado Blood Cancer Institute - PPDS
  • Presbyterian Saint Lukes Medical Center Laboratory
  • Presbyterian/St. Luke's Medical Center
  • Rocky Mountain Cancer Centers (Williams) - USOR
  • Rocky Mountain Cancer Centers (Denver) - USOR
  • Kaiser Foundation Health Plan
  • Laboratory Corporation of America
  • Rocky Mountain Cancer Centers (Lakewood) - USOR
  • Rocky Mountain Cancer Centers (Littleton) - USOR
  • Rocky Mountain Cancer Centers (Lone Tree) - USOR
  • Rocky Mountain Cancer Centers (Longmont) - USOR
  • Rocky Mountain Cancer Centers (Parker) - USOR
  • Rocky Mountain Cancer Centers (Pueblo) - USOR
  • Rocky Mountain Cancer Centers (Thornton) - USOR
  • Medstar Research Institute
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • SCRI Florida Cancer Specialists South
  • SCRI Florida Cancer Specialists South
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • SCRI Florida Cancer Specialists South
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • SCRI Florida Cancer Specialists South
  • SCRI Florida Cancer Specialists South
  • SCRI Florida Cancer Specialists South
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • Mayo Clinic Jacksonville - PPDS
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • University of Miami Miller School of Medicine
  • Baptist Health System (N Kendall) - USOR
  • SCRI Florida Cancer Specialists South
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • SCRI Florida Cancer Specialists South
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • SCRI Florida Cancer Specialists South
  • SCRI Florida Cancer Specialists South
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • SCRI Florida Cancer Specialists South
  • SCRI Florida Cancer Specialists South
  • Cleveland Clinic Florida
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • Winship Cancer Institute, Emory University
  • Saint Alphonsus Regional Medical Center
  • Saint Alphonsus Caldwell Cancer Care Center
  • Saint Alphonsus Medical Center
  • Rush University Medical Center
  • Menorah Medical Center
  • Centerpoint Medical Center
  • HCA Midwest Health - SCRI - PPDS
  • Research Medical Center
  • Nebraska Cancer Specialists
  • New Jersey Hematology Oncology Associates LLC
  • John Theurer Cancer Center
  • New Jersey Hematology and Oncology
  • Weill Cornell Medical Center - Monitoring Location
  • Weill Cornell Medical Center
  • Strong Memorial Hospital
  • University of North Carolina at Chapel Hill
  • Oncology Hematology Care, Inc.
  • Oncology Hematology Care, Inc.
  • Oncology Hematology Care Inc - USOR
  • Oncology Hematology Care Inc - USOR
  • Fairview Hospital
  • The Cleveland Clinic Foundation
  • Oncology Hematology Care, Inc - Fairfield
  • Hillcrest Hospital Cancer Care Center
  • St. Luke's Hospital
  • St. Luke's University Health Network
  • Greenville Health System
  • Greenville Health System
  • Greenville Health System Cancer Institute
  • Greenville Health System
  • Greenville Health System
  • Greenville Health System
  • Tennessee Oncology - DICKSON - SCRI - PPDS
  • Tennessee Oncology - FRANKLIN - SCRI - PPDS
  • Tennessee Oncology - GALLATIN - SCRI - PPDS
  • Tennessee Oncology - SUMMIT - SCRI - PPDS
  • Tennessee Oncology - LEBANON - SCRI - PPDS
  • Tennessee Oncology - MURFREESBORO - SCRI - PPDS
  • Sarah Cannon Center for Blood Centers - SCRI - PPDS
  • Tennessee Oncolgy - BAPTIST - SCRI - PPDS
  • Tennessee Oncology NASH - SCRI - PPDS
  • Tennessee Oncology - ST THOMAS WEST - SCRI - PPDS
  • Tennessee Oncology SKYLINE - SCRI - PPDS
  • Tennessee Oncology - SOUTHERN HILLS - SCRI - PPDS
  • Tennessee Oncology - SHELBYVILLE - SCRI - PPDS
  • Tennessee Oncology - SMYRNA - SCRI - PPDS
  • Texas Oncology (West 38) - USOR
  • Texas Oncology (Balcones) - USOR
  • Texas Oncology (James Casey) - USOR
  • Texas Oncology (Medical City) - USOR
  • Baylor Sammons Cancer Center
  • University of Texas Southwestern Medical Center
  • Texas Oncology (Tyler) - USOR
  • Texas Oncology (E Common) - USOR
  • Texas Oncology (Round Rock) - USOR
  • Texas Oncology - San Antonio Medical Center - USOR
  • Texas Oncology (Tyler) - USOR
  • Oncology and Hematology Associates of Southwest Virginia (Blacksburg) - USOR
  • University of Virginia
  • Oncology and Hematology Associates of Southwest Virginia (Low Moor) - USOR
  • Oncology and Hematology Associates of Southwest Virginia (Roanoke) - USOR
  • Oncology and Hematology Associates of Southwest Virginia Inc
  • Oncology and Hematology Associates of Southwest Virginia
  • Icon Cancer Care Wesley
  • Icon Cancer Care Chermside
  • Icon Cancer Care South Brisbane
  • Icon Cancer Care
  • Icon Cancer Care Southport
  • Royal Hobart Hospital
  • Liverpool Hospital
  • Algemeen Ziekenhuis Klina
  • CHU UCL Namur asbl - Site Godinne
  • AZ Sint-Jan AV
  • Cliniques Universitaires Saint-Luc
  • UZ Leuven
  • Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
  • Liga Norte Riograndense Contra O Cancer
  • Centro de Pesquisas Oncologicas
  • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
  • Universidade Federal do Rio de Janeiro - UFRJ
  • Hospital Santa Marcelina
  • Hospital Santa Marcelina
  • Tom Baker Cancer Centre
  • University of Alberta
  • Kaye Edmonton Clinic
  • Saint John Regional Hospital
  • Sunnybrook Health Sciences Centre
  • Princess Margaret Hospital
  • Princess Margaret Hospital
  • Xuanwu Hospital Capital Medical University
  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
  • Fakultni nemocnice Hradec Kralove
  • Vseobecna Fakultni Nemocnice V Praze
  • Fakultni nemocnice Kralovske Vinohrady
  • Hopital Cote de Nacre
  • CHU Angers
  • Centre Hospitalier Le Mans
  • Hopital Saint Louis
  • Hopital Saint Louis
  • Universitatsklinikum Tubingen
  • Universitatsklinikum Leipzig
  • Universitatsklinikum Carl Gustav Carus an der TU Dresden
  • Marien Hospital Akademisches Lehrkrankenhaus
  • Laiko General Hospital of Athens
  • Athens General Hospital 'G Gennimatas'
  • Attikon University General Hospital
  • University Hospital of Alexandroupolis
  • Laiko General Hospital of Athens
  • University General Hospital of Ioannina
  • University General Hospital of Larissa
  • University General Hospital of Patras
  • Georgios Papanikolaou General Hospital of Thessaloniki
  • Edith Wolfson Medical Center
  • Shaare Zedek Medical Center
  • Hadassah Medical Center PPDS -
  • Galilee Medical Center
  • ZIV Medical Center
  • Tel Aviv Sourasky Medical Center PPDS
  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
  • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
  • Azienda Ospedaliera Universitaria Careggi
  • IRCCS Centro Di Riferimento Oncologico Della Basilicata
  • Istituto Clinico Humanitas
  • Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino
  • Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital
  • Hokkaido University Hospital
  • Fukushima Medical University Hospital
  • Kobe City Medical Center General Hospital
  • University Hospital, Kyoto Prefectural University of Medicine
  • Kindai University Hospital
  • Saitama Medical Center
  • Juntendo University Hospital
  • NTT Medical Center Tokyo
  • Kyushu University Hospital
  • Dokkyo Medical University Hospital
  • Nagasaki University Hospital
  • Osaka Metropolitan University Hospital
  • Yokohama City University Hospital
  • University of Fukui Hospital
  • Pusan National University Hospital
  • Kyungpook National University Hospital
  • Chonnam National University Hwasun Hospital
  • Asan Medical Center - PPDS
  • Samsung Medical Center - PPDS
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Hematologica Alta Especialidad S.C.
  • Capital Humano para Investigacion Clinica SC
  • Instytut Hematologii i Transfuzjologii
  • Uniwersyteckie Centrum Kliniczne, Klinika Hematologii I Transplantologii, Budynek Centrum Medycyny N
  • Uniwersyteckie Centrum Kliniczne
  • Swietokrzyskie Centrum Onkologii
  • Centrum Onkologii Ziemi Lubelskiej
  • Zaklad Diagnostyki Obrazowej SOR
  • Szpital Wojewodzki w Opolu
  • City Clinical Hospital # 40
  • North-West Federal Medical Research Center n.a. V.A. Almazov
  • Russian Research Institute of Hematology and Blood Transfusion
  • ICO lHospitalet Hospital Duran i Reynals
  • Complejo Asistencial Universitario de Leon
  • Hospital Universitario Vall d'Hebron - PPDS
  • Hospital Universitario de La Princesa
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario La Paz - PPDS
  • Complejo Asistencial Universitario de Salamanca - H. Clinico
  • Hospital Clinico Universitario de Valencia
  • Hospital Universitari i Politecnic La Fe de Valencia
  • Gazi University Medical Faculty Gazi Hospital
  • Ege University Medical Faculty
  • Mersin University Medical Faculty
  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
  • Namik Kemal University
  • Karadeniz Technical University Faculty of Medicine
  • Royal Bournemouth Hospital
  • Maidstone Hospital
  • St Bartholomew's Hospital
  • Singleton Hospital - PPDS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Azacitidine 75 mg/m^2

Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2

Arm Description

Azacitidine 75 milligram per square meter (mg/m^2) intravenous (IV) or subcutaneous (SC) injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to approximately 42 months.

Azacitidine 75 mg/m^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to approximately 42 months.

Outcomes

Primary Outcome Measures

Event-Free Survival (EFS)
EFS was defined as the time from randomization to the date of an EFS event. An EFS event was defined as death or transformation to acute myelogenous leukemia (AML) (World Health Organization [WHO] classification as a participant having greater than 20 % blasts in the blood or marrow and an increase of blast count by 50%), whichever event occurred first, in participants with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemias (CMML). An EFS event was defined as death in participants with low-blast AML.

Secondary Outcome Measures

Overall Survival (OS)
Overall survival was defined as the time from randomization to death from any cause.
Kaplan-Meier Estimates of Six-Month Survival Rate
Kaplan-Meier estimates for the probability (expressed as a percentage) of participants that survived at the end of Month 6 from randomization are presented.
Kaplan-Meier Estimates of One-Year Survival Rate
Kaplan-Meier estimates for the probability (expressed as a percentage) of participants that survived at the end of the first year from randomization are presented.
Thirty-Day Mortality Reported as Number of Participants Who Died Up to Day 30
30-day mortality was defined as number of participants who died within 30 days from the first dose of study drug.
Sixty-Day Mortality Reported as Number of Participants Who Died Up to Day 60
60-day mortality was defined as number of participants who died within 60 days from the first dose of study drug.
Time to Acute Myelogenous Leukemia (AML) Transformation in Higher-Risk Myelodysplastic Syndromes (HR MDS), Higher-Risk Chronic Myelomonocytic Leukemias (HR CMML) and HR MDS/CMML Participants
Time to AML transformation in HR MDS and CMML participants was defined as time from randomization to documented AML transformation as determined by the independent review committee (IRC) assessment. Participants who died before progression to AML were censored. Transformation to AML was defined, according to WHO classification, as a participant having 20% blasts in the blood or marrow and increase of blast count by 50%.
Number of Participants With Complete Remission (CR) and CR+ Complete Remission With Incomplete Blood Count Recovery (CRi)
CR for HR MDS or CMML is defined as <=5% myeloblasts with normal maturation of all cell lines in the bone marrow, and greater than or equal to >=11 gram per deciliter (g/dL) hemoglobin (Hgb),>=100*10^9/liter (/L) platelets (pl),>=1.0*10^9/L neutrophils and 0% blasts in peripheral blood. CR for low-blast AML: morphologic leukemia-free state, neutrophils of more than 1.0*10^9/L and pl of >=100*10^9/L, transfusion independence, and no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery (CRi) for low-blast AML: participants fulfill all of the criteria for CR except for residual neutropenia (<1.0*10^9/L) or thrombocytopenia (pl<100*10^9/L).
Number of Participants With CR and Marrow CR
Disease responses for HR MDS or CMML are based on the International Working Group (IWG) Response Criteria for MDS. CR for HR MDS or CMML is defined as <=5% myeloblasts with normal maturation of all cell lines in the bone marrow, and >=11 g/dL Hgb, >=100*10^9/L platelets (pl), >=1.0*10^9/L neutrophils and 0% blasts in peripheral blood. Marrow CR: Bone marrow: <=5% myeloblasts and decrease by >=50% over pretreatment.
Number of Participants With CR, Partial Remission (PR) and Hematologic Improvement (HI)
Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS. CR: <=5% myeloblasts with normal maturation of all bone marrow cell lines, >=11 g/dL Hgb, >=100*10^9/L pl, >=1.0*10^9/L neutrophils,0% blasts in peripheral blood. Marrow CR: Bone marrow: <=5% myeloblasts and decrease by >=50% over pretreatment. PR: all CR criteria met except bone marrow blasts >=50% decrease over pretreatment but still >5%. HI: Hgb increase >=1.5 g/dL if <11 g/dL; pl increase >=30*10^9/L if baseline>20*10^9/L or increase from <20*10^9/L to >20*10^9/L and by at least 100%; neutrophil increase by 100% and absolute increase of >0.5*10^9/L if baseline <1.0*10^9/L.
Number of Participants With CR and Marrow CR and PR
Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS. CR: <=5% myeloblasts with normal maturation of all bone marrow cell lines, >=11 g/dL Hgb, >=100*10^9/L pl, >=1.0*10^9/L neutrophils,0% blasts in peripheral blood. Marrow CR: Bone marrow: <=5% myeloblasts and decrease by >=50% over pretreatment. PR: all CR criteria met except bone marrow blasts >=50% decrease over pretreatment but still >5%.
Number of Participants With CR and Marrow CR, PR and Hematologic Improvement (HI)
Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS. CR: <=5% myeloblasts with normal maturation of all bone marrow cell lines, >=11 g/dL Hgb, >=100*10^9/L pl, >=1.0*10^9/L neutrophils,0% blasts in peripheral blood. Marrow CR: Bone marrow: <=5% myeloblasts and decrease by >=50% over pretreatment. PR: all CR criteria met except bone marrow blasts >=50% decrease over pretreatment but still>5%. HI: Hgb increase >=1.5 g/dL if baseline <11 g/dL; pl increase >=30*10^9/L if baseline>20*10^9/L or increases from <20*10^9/L to >20*10^9/L and by at least 100%; neutrophil increases by 100% and absolute increases of >0.5*10^9/L if baseline <1.0*10^9/L.
Number of Participants With Overall Response (OR)
Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS; for low-blast AML on Revised IWG Response Criteria for AML. Overall response=CR or PR for HR MDS/CMML and CR + CRi + PR for low-blast AML. CR for HR MDS/CMML: <=5% myeloblasts with normal maturation of all bone marrow cell lines, >=11 g/dL Hgb, >=100*10^9/L pl, >=1.0*10^9/L neutrophils, 0% blasts in peripheral blood and PR: all CR criteria met except bone marrow blasts >=50% decrease over pretreatment but still>5%. For low-blast AML-CR:morphologic leukemia-free state>1.0*10^9 neutrophils, >=100*10^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia; CR with incomplete blood count recovery (CRi): fulfill CR criteria except residual neutropenia <1.0*10^9/L or pl <100*10^9/L; PR: all CR hematological values but >=50% decrease in bone marrow aspirate.
Number of Participants With Overall Response 2 (OR2)
OR2=participant with best overall response of CR+PR+HI in HR MDS/CMML participants,or of CR+CRi+PR in low-blast AML participants.CR:≤5% myeloblasts with normal maturation of all bone marrow(BM)cell lines,≥11g/dL Hgb,≥100*10^9/L pl,≥1.0*10^9/L neutrophils,0% blasts in peripheral blood;PR:all CR criteria met except BM blasts ≥50% decrease over pretreatment but still >5%;HI:Hgb increase(inc) ≥1.5g/dL if baseline(BL)<11 g/dL;pl inc≥30*10^9/L if BL>20*10^9/L or inc from <20*10^9/L to >20*10^9/L and by 100%;neutrophil inc by 100%;absolute inc of >0.5*10^9/L if BL<100*10^9/L.For low-blast AML-CR:morphologic leukemia-free state >1.0*10^9 neutrophils,≥100*10^9/L pl,transfusion independence,no residual evidence of extramedullary leukemia;CR with incomplete blood count recovery:fulfill CR criteria except residual neutropenia <1.0*10^9/L or pl<100*10^9/L;PR:all CR hematological values but ≥50% decrease in BM aspirate.Number of responders determined by independent review committee(IRC) assessment.
Duration of Complete Remission (CR)
Duration of CR is first documented CR to the first documentation of PD or relapse from CR (participants with low-blast AML) or relapse after CR or PR (participants with HR MDS/CMML). Disease responses for HR MDS or CMML are based on the Modified IWG Response Criteria for MDS and for low-blast AML on the Revised IWG Response Criteria for AML. CR for HR MDS or CMML is defined as <=5% myeloblasts with normal maturation of all cell lines in the bone marrow, and greater than or equal to >=11 g/dL Hgb,>=100*10^9/L pl,>=1.0*10^9/L neutrophils and 0% blasts in peripheral blood. CR for low-blast AML: morphologic leukemia-free state, neutrophils of more than 1.0*10^9/L and pl of >=100*10^9/L, transfusion independence, and no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery (CRi) for low-blast AML: participants fulfill all of the criteria for CR except for residual neutropenia (<1.0*10^9/L) or thrombocytopenia (pl<100*10^9/L).
Duration of Complete Remission + Complete Remission With Incomplete Blood Count Recovery (CRi)
Duration of CR is first documented CR to the first documentation of PD or relapse from CR (participants with low-blast AML). Disease responses for low-blast AML were based on the Revised IWG Response Criteria for AML. CR is defined as <=5% myeloblasts with normal maturation of all cell lines in the bone marrow, and greater than or equal to >=11 g/dL hemoglobin (Hgb),>=100*10^9/liter (/L) platelets (pl),>=1.0*10^9/L neutrophils and 0% blasts in peripheral blood. CR for low-blast AML: morphologic leukemia-free state, neutrophils of more than 1.0*10^9/L and pl of >=100*10^9/L, transfusion independence, and no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery (CRi) for low-blast AML: participants fulfill all of the criteria for CR except for residual neutropenia (<1.0*10^9/L) or thrombocytopenia (pl<100*10^9/L).
Duration of Overall Response (OR)
Duration of OR: response to first documentation of PD or relapse from CR for low-blast AML or relapse after CR or PR for HR MDS/CMML. Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS; for low-blast AML on Revised IWG Response Criteria for AML. Overall response=CR+PR for HR MDS/CMML and CR+Cri+ PR for low-blast AML.CR for HR MDS/CMML:<=5% myeloblasts with normal maturation of all bone marrow cell lines,>=11 g/dL Hgb,>=100*10^9/L pl,>=1.0*10^9/L neutrophils,0% blasts in peripheral blood and PR:all CR criteria met except bone marrow blasts>=50% decrease over pretreatment but still >5%. For low-blast AML-CR: morphologic leukemia-free state >1.0*10^9 neutrophils,>=100*10^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia; CR with CRi: fulfill CR criteria except residual neutropenia <1.0*10^9/L or pl <100*10^9/L; PR: all CR hematological values but >=50% decrease in % of blasts in bone marrow aspirate.
Duration of Overall Response 2 (OR2)
Duration of OR2: from date of first documentation of CR+PR+HI to first documentation of PD/relapse after CR/PR for responders of CR+PR+HI for HR MDS/CMML and CR,CRi,PR for low-blast AML. For HR MDS/CMML-CR:<=5% myeloblasts with normal maturation of all bone marrow cell lines,>=11 g/dL Hgb, >=100*10^9/L pl,>=1.0*10^9/L neutrophils, 0% blasts in peripheral blood; PR: all CR criteria met except bone marrow blasts>=50% decrease over pretreatment, still >5%; HI:Hgb inc >=1.5 g/dL if baseline <11 g/dL; pl inc>=30*10^9/L if baseline>20*10^9/L or inc from<20*10^9/L to>20*10^9/L by at least 100%; neutrophil inc by 100% and absolute inc of >0.5*10^9/L if baseline <1.0*10^9/L.For low-blast AML-CR: morphologic leukemia-free state,>1.0*10^9 neutrophils,>=100*10^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia;CRi: fulfill CR criteria except residual neutropenia<1.0*10^9/L or pl <100*10^9/L;PR:all CR hematological values but>=50% decrease in bone marrow aspirate.
Percentage of Participants With Red Blood Cells (RBCs) and Platelet-transfusion Independence
A participant was defined as RBC or platelet-transfusion independent if he/she received no RBC or platelet transfusions for a period of at least 8 weeks before the first dose of study drug through 30 days after the last dose of any study drug. Rate of transfusion independence was defined as number of participants who became transfusion independent divided by the number of participants who were transfusion dependent at Baseline.
Duration of Red Blood Cells (RBCs) and Duration of Platelet-transfusion Independence and Duration of Red Blood Cells (RBCs) and Platelet-transfusion Independence
Duration of RBC and platelet transfusion independence was defined as the longest time between the last RBC and/or platelet transfusion before the start of the RBC and/or platelet transfusion-independent period and the first RBC and/or platelet transfusion after the start of the transfusion-independent period, which occurs >= 8 weeks later.
Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission With Incomplete Blood Count Recovery (CRi)
Time to first CR or PR is defined as the time from randomization to first documented CR or PR, whichever occurs first. Disease responses for HR MDS or CMML or low-blast AML cycle 6 are based on Modified IWG Response Criteria for MDS and for low-blast AML on Revised IWG Response Criteria for AML. For HR MDS or CMML-CR:<=5% myeloblasts with normal maturation of all bone marrow cell lines,>=11 g/dL Hgb,>=100*10^9/L pl,>=1.0*10^9/L neutrophils, 0% blasts in peripheral blood; PR: all CR criteria met except bone marrow blasts>=50% decrease over pretreatment but still>5%; For low-blast AML-CR: morphologic leukemia-free state,>1.0*10^9/L neutrophils, pl>=100*10^9/L, transfusion independence, no residual evidence of extramedullary leukemia; CR with incomplete blood count recovery: fulfill CR criteria except residual neutropenia<1.0*10^9/L or pl <100*10^9/L; PR: all CR hematological values but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate.
Number of Participants With Hematologic Improvement (HI)
Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS. HI: Hgb increase >=1.5 g/dL if baseline <11 g/dL; pl increase >=30*10^9/L if baseline >20*10^9/L or increase from <20*10^9/L to >20*10^9/L by at least 100%; neutrophil increase by 100% and absolute increase of >0.5*10^9/L if baseline <1.0*10^9/L.
Number of Participants With at Least 1 Inpatient Hospital Admissions Related to HR MDS, CMML or Low-blast AML
Inpatient hospital admission data was collected through transformation to AML (HR MDS/CMML participants) or disease progression (low-blast AML participants) or until initiation of subsequent therapy (all participants), whichever occurred first. Transformation to AML is defined, according to WHO Classification, as a participant having 20% blasts in the blood or marrow and increase of blast count by 50%.
Time to Progressive Disease (PD), Relapse After CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death
Time to PD, relapse after CR(low-blast AML), relapse after CR or PR(HR MDS/CMML), or death,defined as time from date of randomization until date of first documentation of PD,relapse after CR(low-blast AML),relapse after CR or PR(HR MDS/CMML),or death due to any cause, whichever occurs first. In HR MDS/CMML,PD: Participants with<5% blasts:>=50% inc >5% blasts, with 5%-9% blasts:>=50% inc>10% blasts, with 10%-19% blasts:>=50% inc >20% blasts,with 20%-30% blasts, at least 50% decrement from maximum remission/response in granulocytes or pl or reduction in Hgb by>=2 g/dL/new transfusion dependence.Relapse after CR or PR: return to pretreatment bone marrow blast %/Decrement of >=50% from maximum remission/response levels in granulocytes/pl/reduction in Hgb conc.>=1.5 g/dL/transfusion dependence. In AML,PD:>50% inc in bone marrow blasts to >30% blasts,>50% inc in circulating blasts to>30% blasts in peripheral blood, Development of extramedullary disease/new sites of extramedullary leukemia.
Health-Related Quality of Life (HRQOL) Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30
The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. Most of the 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL. The percentage of participants for each parameter score were categorized as improved, stable, and worsened. Only categories with at least one participant with event are reported.
Plasma Concentration of Pevonedistat
Number of Participants With Overall Response in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group
Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS; for low-blast AML on Revised IWG Response Criteria for AML. Overall response=CR + PR for HR MDS/CMML and CR + CRi + PR for low-blast AML. CR for HR MDS/CMML: <=5% myeloblasts with normal maturation of all bone marrow cell lines, >=11 g/dL Hgb, >=100*10^9/L pl, >=1.0*10^9/L neutrophils,0% blasts in peripheral blood and PR: all CR criteria met except bone marrow blasts>=50% decrease over pretreatment but still>5%. For low-blast AML-CR: morphologic leukemia-free state, >1.0*10^9 neutrophils,>=100*10^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia; CR with incomplete blood count recovery (CRi): fulfill CR criteria except residual neutropenia<1.0*10^9/L or pl<100*10^9/L; PR: all CR hematological values but>=50% decrease in the percentage of blasts to 5% to 25% in bone marrow aspirate.
Event-Free Survival in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group
Event was defined as death or transformation to AML in participants with MDS or CMML, whichever occurred first. Transformation to AML was defined, according to World Health Organization (WHO) Classification as a participant having >20% blasts in the blood or marrow and increase of blast count by 50%. Event was defined as death in participants with low-blast AML.
Overall Survival in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group
OS was calculated from date of randomization to the date of death due to any cause. Participants without documented death at the time of the analysis were censored as of the date the participant was last known to be alive.
Number of Participants With Overall Response by Cycle 6
Responses for HR MDS/CMML are based on Modified International Working Group (IWG) Response Criteria for MDS and for low-blast AML on Revised IWG Response Criteria for AML. Overall response=CR and PR for HR MDS/CMML and CR+CR with incomplete blood count recovery(CRi)+PR for low-blast AML. CR for HR MDS/CMML:<=5% myeloblasts with normal maturation of all bone marrow cell lines,>=11g/dL hemoglobin (Hgb),>=100*10^9/L platelet (pl),>=1.0*10^9/L neutrophils, 0% blasts in peripheral blood, and PR:all CR criteria met except bone marrow blasts >=50% decrease over pretreatment but still >5%. For low-blast AML-CR:morphologic leukemia-free state,>1.0*10^9 neutrophils, >=100*10^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia;CRi:fulfill CR criteria except residual neutropenia <1.0*10^9/L/thrombocytopenia (pl<100*10^9/L); PR:all CR hematological values but>=50% decrease in percentage of blasts to 5%-25% in bone marrow aspirate.

Full Information

First Posted
August 30, 2017
Last Updated
August 22, 2023
Sponsor
Takeda
Collaborators
Takeda Development Center Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03268954
Brief Title
Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)
Acronym
PANTHER
Official Title
A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
Collaborators
Takeda Development Center Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML).
Detailed Description
The drug being tested in this study is called pevonedistat. Pevonedistat is being tested to treat people with higher-risk myelodysplastic syndromes (HR MDS), chronic myelomonocytic leukemia (CMML) and low-blast acute myelogenous leukemia (AML) as a combination treatment with azacitidine. This study will look at the overall survival, event-free survival and response to treatment in people who take pevonedistat and azacitidine when compared to people who take single-agent azacitidine. The study will enroll approximately 450 participants. Once enrolled, participants will be randomly assigned in 1:1 ratio (by chance, like flipping a coin) to one of the two treatment groups in 28-day treatment cycles: Pevonedistat 20 mg/m^2 and azacitidine 75 mg/m^2 combination Single-agent azacitidine 75 mg/m^2 All participants will receive azacitidine via intravenous or subcutaneous route. Participants randomized to the combination arm will also receive pevonedistat intravenous infusion. This multi-center trial will be conducted Spain, Belgium, Brazil, Canada, Czech Republic, France, Germany, Israel, Italy, the United States, Australia, Greece, Japan, Mexico, Poland, Russia, Korea, Turkey, China and United Kingdom. The overall time to participate in this study is approximately 63 months. Participants will attend the end-of-treatment visit 30 days after the last dose of study drug or before the start of subsequent anti-neoplastic therapy if that occurs sooner. Participants with HR MDS or CMML will have EFS follow-up study visits every month if their disease has not transformed to AML and they have not started subsequent therapy. Participants with low-blast AML will have response follow-up study visits every month until they relapse from CR or meet the criteria for PD. All participants will enter OS follow-up (contacted every 3 months) when they have confirmed transformation to AML (for participants with HR MDS or CMML at enrollment) or experienced PD (for participants with low-blast AML at study enrollment).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Keywords
Drug therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
454 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azacitidine 75 mg/m^2
Arm Type
Experimental
Arm Description
Azacitidine 75 milligram per square meter (mg/m^2) intravenous (IV) or subcutaneous (SC) injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to approximately 42 months.
Arm Title
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2
Arm Type
Experimental
Arm Description
Azacitidine 75 mg/m^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to approximately 42 months.
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Azacitidine intravenous or subcutaneous formulation.
Intervention Type
Drug
Intervention Name(s)
Pevonedistat
Intervention Description
Pevonedistat intravenous infusion.
Primary Outcome Measure Information:
Title
Event-Free Survival (EFS)
Description
EFS was defined as the time from randomization to the date of an EFS event. An EFS event was defined as death or transformation to acute myelogenous leukemia (AML) (World Health Organization [WHO] classification as a participant having greater than 20 % blasts in the blood or marrow and an increase of blast count by 50%), whichever event occurred first, in participants with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemias (CMML). An EFS event was defined as death in participants with low-blast AML.
Time Frame
From randomization until transformation to acute myeloid leukemia, or death due to any cause up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival was defined as the time from randomization to death from any cause.
Time Frame
Up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Kaplan-Meier Estimates of Six-Month Survival Rate
Description
Kaplan-Meier estimates for the probability (expressed as a percentage) of participants that survived at the end of Month 6 from randomization are presented.
Time Frame
Up to Month 6
Title
Kaplan-Meier Estimates of One-Year Survival Rate
Description
Kaplan-Meier estimates for the probability (expressed as a percentage) of participants that survived at the end of the first year from randomization are presented.
Time Frame
Up to Year 1
Title
Thirty-Day Mortality Reported as Number of Participants Who Died Up to Day 30
Description
30-day mortality was defined as number of participants who died within 30 days from the first dose of study drug.
Time Frame
Up to Day 30
Title
Sixty-Day Mortality Reported as Number of Participants Who Died Up to Day 60
Description
60-day mortality was defined as number of participants who died within 60 days from the first dose of study drug.
Time Frame
Up to Day 60
Title
Time to Acute Myelogenous Leukemia (AML) Transformation in Higher-Risk Myelodysplastic Syndromes (HR MDS), Higher-Risk Chronic Myelomonocytic Leukemias (HR CMML) and HR MDS/CMML Participants
Description
Time to AML transformation in HR MDS and CMML participants was defined as time from randomization to documented AML transformation as determined by the independent review committee (IRC) assessment. Participants who died before progression to AML were censored. Transformation to AML was defined, according to WHO classification, as a participant having 20% blasts in the blood or marrow and increase of blast count by 50%.
Time Frame
From randomization until transformation to AML till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Number of Participants With Complete Remission (CR) and CR+ Complete Remission With Incomplete Blood Count Recovery (CRi)
Description
CR for HR MDS or CMML is defined as <=5% myeloblasts with normal maturation of all cell lines in the bone marrow, and greater than or equal to >=11 gram per deciliter (g/dL) hemoglobin (Hgb),>=100*10^9/liter (/L) platelets (pl),>=1.0*10^9/L neutrophils and 0% blasts in peripheral blood. CR for low-blast AML: morphologic leukemia-free state, neutrophils of more than 1.0*10^9/L and pl of >=100*10^9/L, transfusion independence, and no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery (CRi) for low-blast AML: participants fulfill all of the criteria for CR except for residual neutropenia (<1.0*10^9/L) or thrombocytopenia (pl<100*10^9/L).
Time Frame
From randomization until CR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Number of Participants With CR and Marrow CR
Description
Disease responses for HR MDS or CMML are based on the International Working Group (IWG) Response Criteria for MDS. CR for HR MDS or CMML is defined as <=5% myeloblasts with normal maturation of all cell lines in the bone marrow, and >=11 g/dL Hgb, >=100*10^9/L platelets (pl), >=1.0*10^9/L neutrophils and 0% blasts in peripheral blood. Marrow CR: Bone marrow: <=5% myeloblasts and decrease by >=50% over pretreatment.
Time Frame
From randomization until CR or marrow CR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Number of Participants With CR, Partial Remission (PR) and Hematologic Improvement (HI)
Description
Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS. CR: <=5% myeloblasts with normal maturation of all bone marrow cell lines, >=11 g/dL Hgb, >=100*10^9/L pl, >=1.0*10^9/L neutrophils,0% blasts in peripheral blood. Marrow CR: Bone marrow: <=5% myeloblasts and decrease by >=50% over pretreatment. PR: all CR criteria met except bone marrow blasts >=50% decrease over pretreatment but still >5%. HI: Hgb increase >=1.5 g/dL if <11 g/dL; pl increase >=30*10^9/L if baseline>20*10^9/L or increase from <20*10^9/L to >20*10^9/L and by at least 100%; neutrophil increase by 100% and absolute increase of >0.5*10^9/L if baseline <1.0*10^9/L.
Time Frame
From randomization until, CR, PR or HI till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Number of Participants With CR and Marrow CR and PR
Description
Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS. CR: <=5% myeloblasts with normal maturation of all bone marrow cell lines, >=11 g/dL Hgb, >=100*10^9/L pl, >=1.0*10^9/L neutrophils,0% blasts in peripheral blood. Marrow CR: Bone marrow: <=5% myeloblasts and decrease by >=50% over pretreatment. PR: all CR criteria met except bone marrow blasts >=50% decrease over pretreatment but still >5%.
Time Frame
From randomization until CR or Marrow CR and PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Number of Participants With CR and Marrow CR, PR and Hematologic Improvement (HI)
Description
Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS. CR: <=5% myeloblasts with normal maturation of all bone marrow cell lines, >=11 g/dL Hgb, >=100*10^9/L pl, >=1.0*10^9/L neutrophils,0% blasts in peripheral blood. Marrow CR: Bone marrow: <=5% myeloblasts and decrease by >=50% over pretreatment. PR: all CR criteria met except bone marrow blasts >=50% decrease over pretreatment but still>5%. HI: Hgb increase >=1.5 g/dL if baseline <11 g/dL; pl increase >=30*10^9/L if baseline>20*10^9/L or increases from <20*10^9/L to >20*10^9/L and by at least 100%; neutrophil increases by 100% and absolute increases of >0.5*10^9/L if baseline <1.0*10^9/L.
Time Frame
From randomization until CR, marrow CR, PR or HI till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Number of Participants With Overall Response (OR)
Description
Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS; for low-blast AML on Revised IWG Response Criteria for AML. Overall response=CR or PR for HR MDS/CMML and CR + CRi + PR for low-blast AML. CR for HR MDS/CMML: <=5% myeloblasts with normal maturation of all bone marrow cell lines, >=11 g/dL Hgb, >=100*10^9/L pl, >=1.0*10^9/L neutrophils, 0% blasts in peripheral blood and PR: all CR criteria met except bone marrow blasts >=50% decrease over pretreatment but still>5%. For low-blast AML-CR:morphologic leukemia-free state>1.0*10^9 neutrophils, >=100*10^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia; CR with incomplete blood count recovery (CRi): fulfill CR criteria except residual neutropenia <1.0*10^9/L or pl <100*10^9/L; PR: all CR hematological values but >=50% decrease in bone marrow aspirate.
Time Frame
From randomization until CR and PR or CR, CRi and PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Number of Participants With Overall Response 2 (OR2)
Description
OR2=participant with best overall response of CR+PR+HI in HR MDS/CMML participants,or of CR+CRi+PR in low-blast AML participants.CR:≤5% myeloblasts with normal maturation of all bone marrow(BM)cell lines,≥11g/dL Hgb,≥100*10^9/L pl,≥1.0*10^9/L neutrophils,0% blasts in peripheral blood;PR:all CR criteria met except BM blasts ≥50% decrease over pretreatment but still >5%;HI:Hgb increase(inc) ≥1.5g/dL if baseline(BL)<11 g/dL;pl inc≥30*10^9/L if BL>20*10^9/L or inc from <20*10^9/L to >20*10^9/L and by 100%;neutrophil inc by 100%;absolute inc of >0.5*10^9/L if BL<100*10^9/L.For low-blast AML-CR:morphologic leukemia-free state >1.0*10^9 neutrophils,≥100*10^9/L pl,transfusion independence,no residual evidence of extramedullary leukemia;CR with incomplete blood count recovery:fulfill CR criteria except residual neutropenia <1.0*10^9/L or pl<100*10^9/L;PR:all CR hematological values but ≥50% decrease in BM aspirate.Number of responders determined by independent review committee(IRC) assessment.
Time Frame
From randomization until, CR, PR or HI or CR, CRi or PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Duration of Complete Remission (CR)
Description
Duration of CR is first documented CR to the first documentation of PD or relapse from CR (participants with low-blast AML) or relapse after CR or PR (participants with HR MDS/CMML). Disease responses for HR MDS or CMML are based on the Modified IWG Response Criteria for MDS and for low-blast AML on the Revised IWG Response Criteria for AML. CR for HR MDS or CMML is defined as <=5% myeloblasts with normal maturation of all cell lines in the bone marrow, and greater than or equal to >=11 g/dL Hgb,>=100*10^9/L pl,>=1.0*10^9/L neutrophils and 0% blasts in peripheral blood. CR for low-blast AML: morphologic leukemia-free state, neutrophils of more than 1.0*10^9/L and pl of >=100*10^9/L, transfusion independence, and no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery (CRi) for low-blast AML: participants fulfill all of the criteria for CR except for residual neutropenia (<1.0*10^9/L) or thrombocytopenia (pl<100*10^9/L).
Time Frame
From CR until first documentation of PD or relapse from CR or relapse after CR or PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Duration of Complete Remission + Complete Remission With Incomplete Blood Count Recovery (CRi)
Description
Duration of CR is first documented CR to the first documentation of PD or relapse from CR (participants with low-blast AML). Disease responses for low-blast AML were based on the Revised IWG Response Criteria for AML. CR is defined as <=5% myeloblasts with normal maturation of all cell lines in the bone marrow, and greater than or equal to >=11 g/dL hemoglobin (Hgb),>=100*10^9/liter (/L) platelets (pl),>=1.0*10^9/L neutrophils and 0% blasts in peripheral blood. CR for low-blast AML: morphologic leukemia-free state, neutrophils of more than 1.0*10^9/L and pl of >=100*10^9/L, transfusion independence, and no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery (CRi) for low-blast AML: participants fulfill all of the criteria for CR except for residual neutropenia (<1.0*10^9/L) or thrombocytopenia (pl<100*10^9/L).
Time Frame
From CR until first documentation of PD or relapse from CR or relapse after CR or PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Duration of Overall Response (OR)
Description
Duration of OR: response to first documentation of PD or relapse from CR for low-blast AML or relapse after CR or PR for HR MDS/CMML. Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS; for low-blast AML on Revised IWG Response Criteria for AML. Overall response=CR+PR for HR MDS/CMML and CR+Cri+ PR for low-blast AML.CR for HR MDS/CMML:<=5% myeloblasts with normal maturation of all bone marrow cell lines,>=11 g/dL Hgb,>=100*10^9/L pl,>=1.0*10^9/L neutrophils,0% blasts in peripheral blood and PR:all CR criteria met except bone marrow blasts>=50% decrease over pretreatment but still >5%. For low-blast AML-CR: morphologic leukemia-free state >1.0*10^9 neutrophils,>=100*10^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia; CR with CRi: fulfill CR criteria except residual neutropenia <1.0*10^9/L or pl <100*10^9/L; PR: all CR hematological values but >=50% decrease in % of blasts in bone marrow aspirate.
Time Frame
Up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Duration of Overall Response 2 (OR2)
Description
Duration of OR2: from date of first documentation of CR+PR+HI to first documentation of PD/relapse after CR/PR for responders of CR+PR+HI for HR MDS/CMML and CR,CRi,PR for low-blast AML. For HR MDS/CMML-CR:<=5% myeloblasts with normal maturation of all bone marrow cell lines,>=11 g/dL Hgb, >=100*10^9/L pl,>=1.0*10^9/L neutrophils, 0% blasts in peripheral blood; PR: all CR criteria met except bone marrow blasts>=50% decrease over pretreatment, still >5%; HI:Hgb inc >=1.5 g/dL if baseline <11 g/dL; pl inc>=30*10^9/L if baseline>20*10^9/L or inc from<20*10^9/L to>20*10^9/L by at least 100%; neutrophil inc by 100% and absolute inc of >0.5*10^9/L if baseline <1.0*10^9/L.For low-blast AML-CR: morphologic leukemia-free state,>1.0*10^9 neutrophils,>=100*10^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia;CRi: fulfill CR criteria except residual neutropenia<1.0*10^9/L or pl <100*10^9/L;PR:all CR hematological values but>=50% decrease in bone marrow aspirate.
Time Frame
Up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Percentage of Participants With Red Blood Cells (RBCs) and Platelet-transfusion Independence
Description
A participant was defined as RBC or platelet-transfusion independent if he/she received no RBC or platelet transfusions for a period of at least 8 weeks before the first dose of study drug through 30 days after the last dose of any study drug. Rate of transfusion independence was defined as number of participants who became transfusion independent divided by the number of participants who were transfusion dependent at Baseline.
Time Frame
Up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Duration of Red Blood Cells (RBCs) and Duration of Platelet-transfusion Independence and Duration of Red Blood Cells (RBCs) and Platelet-transfusion Independence
Description
Duration of RBC and platelet transfusion independence was defined as the longest time between the last RBC and/or platelet transfusion before the start of the RBC and/or platelet transfusion-independent period and the first RBC and/or platelet transfusion after the start of the transfusion-independent period, which occurs >= 8 weeks later.
Time Frame
Up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission With Incomplete Blood Count Recovery (CRi)
Description
Time to first CR or PR is defined as the time from randomization to first documented CR or PR, whichever occurs first. Disease responses for HR MDS or CMML or low-blast AML cycle 6 are based on Modified IWG Response Criteria for MDS and for low-blast AML on Revised IWG Response Criteria for AML. For HR MDS or CMML-CR:<=5% myeloblasts with normal maturation of all bone marrow cell lines,>=11 g/dL Hgb,>=100*10^9/L pl,>=1.0*10^9/L neutrophils, 0% blasts in peripheral blood; PR: all CR criteria met except bone marrow blasts>=50% decrease over pretreatment but still>5%; For low-blast AML-CR: morphologic leukemia-free state,>1.0*10^9/L neutrophils, pl>=100*10^9/L, transfusion independence, no residual evidence of extramedullary leukemia; CR with incomplete blood count recovery: fulfill CR criteria except residual neutropenia<1.0*10^9/L or pl <100*10^9/L; PR: all CR hematological values but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate.
Time Frame
From randomization until CR or PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Number of Participants With Hematologic Improvement (HI)
Description
Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS. HI: Hgb increase >=1.5 g/dL if baseline <11 g/dL; pl increase >=30*10^9/L if baseline >20*10^9/L or increase from <20*10^9/L to >20*10^9/L by at least 100%; neutrophil increase by 100% and absolute increase of >0.5*10^9/L if baseline <1.0*10^9/L.
Time Frame
From randomization until HI till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Number of Participants With at Least 1 Inpatient Hospital Admissions Related to HR MDS, CMML or Low-blast AML
Description
Inpatient hospital admission data was collected through transformation to AML (HR MDS/CMML participants) or disease progression (low-blast AML participants) or until initiation of subsequent therapy (all participants), whichever occurred first. Transformation to AML is defined, according to WHO Classification, as a participant having 20% blasts in the blood or marrow and increase of blast count by 50%.
Time Frame
From randomization until transformation to AML or until initiation of subsequent therapy till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Time to Progressive Disease (PD), Relapse After CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death
Description
Time to PD, relapse after CR(low-blast AML), relapse after CR or PR(HR MDS/CMML), or death,defined as time from date of randomization until date of first documentation of PD,relapse after CR(low-blast AML),relapse after CR or PR(HR MDS/CMML),or death due to any cause, whichever occurs first. In HR MDS/CMML,PD: Participants with<5% blasts:>=50% inc >5% blasts, with 5%-9% blasts:>=50% inc>10% blasts, with 10%-19% blasts:>=50% inc >20% blasts,with 20%-30% blasts, at least 50% decrement from maximum remission/response in granulocytes or pl or reduction in Hgb by>=2 g/dL/new transfusion dependence.Relapse after CR or PR: return to pretreatment bone marrow blast %/Decrement of >=50% from maximum remission/response levels in granulocytes/pl/reduction in Hgb conc.>=1.5 g/dL/transfusion dependence. In AML,PD:>50% inc in bone marrow blasts to >30% blasts,>50% inc in circulating blasts to>30% blasts in peripheral blood, Development of extramedullary disease/new sites of extramedullary leukemia.
Time Frame
From randomization until PD, relapse after CR, or relapse after CR or PR, or death due to any cause, whichever occurs first till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Health-Related Quality of Life (HRQOL) Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30
Description
The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. Most of the 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL. The percentage of participants for each parameter score were categorized as improved, stable, and worsened. Only categories with at least one participant with event are reported.
Time Frame
Up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Plasma Concentration of Pevonedistat
Time Frame
Cycle 1 Day 1 predose and multiple time points (up to 4 hours) post dose; Cycle 1 Days 3 and 5 predose; Cycle 2 and 4 Day 1 at multiple time points (up to 3 hours) post dose; Cycle 4 Day 3 predose (Cycle length= 28 days)
Title
Number of Participants With Overall Response in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group
Description
Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS; for low-blast AML on Revised IWG Response Criteria for AML. Overall response=CR + PR for HR MDS/CMML and CR + CRi + PR for low-blast AML. CR for HR MDS/CMML: <=5% myeloblasts with normal maturation of all bone marrow cell lines, >=11 g/dL Hgb, >=100*10^9/L pl, >=1.0*10^9/L neutrophils,0% blasts in peripheral blood and PR: all CR criteria met except bone marrow blasts>=50% decrease over pretreatment but still>5%. For low-blast AML-CR: morphologic leukemia-free state, >1.0*10^9 neutrophils,>=100*10^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia; CR with incomplete blood count recovery (CRi): fulfill CR criteria except residual neutropenia<1.0*10^9/L or pl<100*10^9/L; PR: all CR hematological values but>=50% decrease in the percentage of blasts to 5% to 25% in bone marrow aspirate.
Time Frame
From randomization until CR, CRi and PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Event-Free Survival in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group
Description
Event was defined as death or transformation to AML in participants with MDS or CMML, whichever occurred first. Transformation to AML was defined, according to World Health Organization (WHO) Classification as a participant having >20% blasts in the blood or marrow and increase of blast count by 50%. Event was defined as death in participants with low-blast AML.
Time Frame
From randomization until transformation to AML if eligible or death till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Overall Survival in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group
Description
OS was calculated from date of randomization to the date of death due to any cause. Participants without documented death at the time of the analysis were censored as of the date the participant was last known to be alive.
Time Frame
From randomization until death till data cut-off date: 28 May 2021 (up to approximately 42 months)
Title
Number of Participants With Overall Response by Cycle 6
Description
Responses for HR MDS/CMML are based on Modified International Working Group (IWG) Response Criteria for MDS and for low-blast AML on Revised IWG Response Criteria for AML. Overall response=CR and PR for HR MDS/CMML and CR+CR with incomplete blood count recovery(CRi)+PR for low-blast AML. CR for HR MDS/CMML:<=5% myeloblasts with normal maturation of all bone marrow cell lines,>=11g/dL hemoglobin (Hgb),>=100*10^9/L platelet (pl),>=1.0*10^9/L neutrophils, 0% blasts in peripheral blood, and PR:all CR criteria met except bone marrow blasts >=50% decrease over pretreatment but still >5%. For low-blast AML-CR:morphologic leukemia-free state,>1.0*10^9 neutrophils, >=100*10^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia;CRi:fulfill CR criteria except residual neutropenia <1.0*10^9/L/thrombocytopenia (pl<100*10^9/L); PR:all CR hematological values but>=50% decrease in percentage of blasts to 5%-25% in bone marrow aspirate.
Time Frame
Up to Cycle 6 (up to approximately Day 168)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has morphologically confirmed diagnosis of myelodysplastic syndromes (MDS) or CMML (i.e., with white blood cell [WBC] <13,000/microliter [mcL]) or low-blast acute myelogenous leukemia (AML). Has MDS or CMML and must also have one of the following Prognostic Risk Categories, based on the Revised International Prognostic Scoring System (IPSS-R): Very high (>6 points). High (>4.5-6 points). Intermediate (>3-4.5 points): a participant determined to be in the Intermediate Prognostic Risk Category is only allowable in the setting of >=5% bone marrow myeloblasts. Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2. Participants with AML (20%-30% blasts) must have a treatment-related mortality (TRM) score >=4 for intensive, induction chemotherapy as calculated using the simplified model described by Walter and coworkers. Calculation of TRM score: 0 for (age <61 years), +2 for (age 61-70 years), +4 for (age >=71 years). + 0 for (PS=0), +2 for (PS=1), +4 for (PS >1). + 0 for (platelets <50), +1 for (platelets >=50). Exclusion Criteria: Has previous treatment for HR MDS or CMML or low-blast AML with chemotherapy or other antineoplastic agents including hypomethylating agent (HMAs) such as decitabine or azacitidine. Previous treatment is permitted with hydroxyurea and with lenalidomide, except that lenalidomide may not be given within 8 weeks before the first dose of study drug. Has acute promyelocytic leukemia as diagnosed by morphologic examination of bone marrow, by fluorescent in situ hybridization or cytogenetics of peripheral blood or bone marrow, or by other accepted analysis. Participants with AML with a WBC count >50,000/mcL. Participants who are cytoreduced with leukapheresis or with hydroxyurea may be enrolled if they meet the eligibility criteria. Is eligible for intensive chemotherapy and/or allogeneic stem cell transplantation. The reason a participant is not eligible for intensive chemotherapy and/or allogeneic stem cell transplantation may consist of one or more of the following factors: Age >75. Comorbidities. Inability to tolerate intensive chemotherapy (e.g., participants with AML with 20%-30% blasts and TRM >=4). Physician decision (e.g., lack of available stem cell donor). The reason a participant is not eligible should be documented in the electronic case report form (eCRF). Has either clinical evidence of or history of central nervous system involvement by AML. Has active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia. Is diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Has nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection. Has prothrombin time (PT) or aPTT >1.5× upper limit of normal (ULN) or active uncontrolled coagulopathy or bleeding disorder. Participants therapeutically anticoagulated with warfarin, direct thrombin inhibitors, direct factor Xa inhibitors, or heparin are excluded from enrollment. Has known human immunodeficiency virus (HIV) seropositive. Has known hepatitis B surface antigen seropositive, or known or suspected active hepatitis C infection. Note: Participants who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Has known hepatic cirrhosis or severe preexisting hepatic impairment. Has known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure (New York Heart Association Class III or IV), and/or myocardial infarction within 6 months before first dose, or severe pulmonary hypertension. Has treatment with strong cytochrome P 3A (CYP3A) inducers within 14 days before the first dose of pevonedistat.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Southern Cancer Center - USOR
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
Southern Cancer Center - USOR
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Facility Name
Southern Cancer Center - USOR
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Southern Cancer Center- USOR
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Southeastern Regional Medical Center - CTCA - PPDS
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
Arizona Oncology Associates (Orange HOPE) - USOR
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Arizona Oncology Associates (Rudasill HOPE) - USOR
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Arizona Oncology Associates (Wilmot HOPE) - USOR
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Compassionate Cancer Care Medical Group Inc
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Emad Ibrahim, MD, Inc
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Rocky Mountain Cancer Centers (Aurora) - USOR
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Rocky Mountain Cancer Centers (Boulder) - USOR
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Rocky Mountain Cancer Centers (Colorado Springs) - USOR
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Quest Diagnostics, INC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Colorado Blood Cancer Institute - PPDS
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Presbyterian Saint Lukes Medical Center Laboratory
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Presbyterian/St. Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rocky Mountain Cancer Centers (Williams) - USOR
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rocky Mountain Cancer Centers (Denver) - USOR
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Kaiser Foundation Health Plan
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Laboratory Corporation of America
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Rocky Mountain Cancer Centers (Lakewood) - USOR
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Rocky Mountain Cancer Centers (Littleton) - USOR
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Rocky Mountain Cancer Centers (Lone Tree) - USOR
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Rocky Mountain Cancer Centers (Longmont) - USOR
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Rocky Mountain Cancer Centers (Parker) - USOR
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Rocky Mountain Cancer Centers (Pueblo) - USOR
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81008
Country
United States
Facility Name
Rocky Mountain Cancer Centers (Thornton) - USOR
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
Facility Name
Medstar Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Bonita Springs
State/Province
Florida
ZIP/Postal Code
34135
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33914
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Mayo Clinic Jacksonville - PPDS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Baptist Health System (N Kendall) - USOR
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34236
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34608
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
The Villages
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Venice
State/Province
Florida
ZIP/Postal Code
34285
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Venice
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Florida Cancer Specialists - NORTH - SCRI - PPDS
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Saint Alphonsus Caldwell Cancer Care Center
City
Caldwell
State/Province
Idaho
ZIP/Postal Code
83605
Country
United States
Facility Name
Saint Alphonsus Medical Center
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Centerpoint Medical Center
City
Independence
State/Province
Missouri
ZIP/Postal Code
64057
Country
United States
Facility Name
HCA Midwest Health - SCRI - PPDS
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
New Jersey Hematology Oncology Associates LLC
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
John Theurer Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
New Jersey Hematology and Oncology
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Weill Cornell Medical Center - Monitoring Location
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45211
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45230
Country
United States
Facility Name
Oncology Hematology Care Inc - USOR
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Oncology Hematology Care Inc - USOR
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oncology Hematology Care, Inc - Fairfield
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Hillcrest Hospital Cancer Care Center
City
Mayfield
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
St. Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
St. Luke's University Health Network
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Greenville Health System
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Greenville Health System Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Greenville Health System
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Greenville Health System
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
Greenville Health System
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
Tennessee Oncology - DICKSON - SCRI - PPDS
City
Dickson
State/Province
Tennessee
ZIP/Postal Code
37055
Country
United States
Facility Name
Tennessee Oncology - FRANKLIN - SCRI - PPDS
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Tennessee Oncology - GALLATIN - SCRI - PPDS
City
Gallatin
State/Province
Tennessee
ZIP/Postal Code
37066
Country
United States
Facility Name
Tennessee Oncology - SUMMIT - SCRI - PPDS
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Tennessee Oncology - LEBANON - SCRI - PPDS
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37090
Country
United States
Facility Name
Tennessee Oncology - MURFREESBORO - SCRI - PPDS
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37129
Country
United States
Facility Name
Sarah Cannon Center for Blood Centers - SCRI - PPDS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncolgy - BAPTIST - SCRI - PPDS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology NASH - SCRI - PPDS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology - ST THOMAS WEST - SCRI - PPDS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Tennessee Oncology SKYLINE - SCRI - PPDS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37207
Country
United States
Facility Name
Tennessee Oncology - SOUTHERN HILLS - SCRI - PPDS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Tennessee Oncology - SHELBYVILLE - SCRI - PPDS
City
Shelbyville
State/Province
Tennessee
ZIP/Postal Code
37160
Country
United States
Facility Name
Tennessee Oncology - SMYRNA - SCRI - PPDS
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Texas Oncology (West 38) - USOR
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Oncology (Balcones) - USOR
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology (James Casey) - USOR
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Oncology (Medical City) - USOR
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Oncology (Tyler) - USOR
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Texas Oncology (E Common) - USOR
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Texas Oncology (Round Rock) - USOR
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Texas Oncology - San Antonio Medical Center - USOR
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Texas Oncology (Tyler) - USOR
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia (Blacksburg) - USOR
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia (Low Moor) - USOR
City
Low Moor
State/Province
Virginia
ZIP/Postal Code
24457
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia (Roanoke) - USOR
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia Inc
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia
City
Wytheville
State/Province
Virginia
ZIP/Postal Code
24382
Country
United States
Facility Name
Icon Cancer Care Wesley
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Icon Cancer Care Chermside
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Icon Cancer Care South Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Icon Cancer Care
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Icon Cancer Care Southport
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
ZIP/Postal Code
1871
Country
Australia
Facility Name
Algemeen Ziekenhuis Klina
City
Brasschaat
State/Province
Antwerpen
ZIP/Postal Code
2930
Country
Belgium
Facility Name
CHU UCL Namur asbl - Site Godinne
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
AZ Sint-Jan AV
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Liga Norte Riograndense Contra O Cancer
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Centro de Pesquisas Oncologicas
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Universidade Federal do Rio de Janeiro - UFRJ
City
Rio De Janeiro
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Hospital Santa Marcelina
City
Sao Paulo
ZIP/Postal Code
08270-120
Country
Brazil
Facility Name
Hospital Santa Marcelina
City
Sao Paulo
ZIP/Postal Code
08270-270
Country
Brazil
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Kaye Edmonton Clinic
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z1
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
State/Province
Kralovehradeck Kraj
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Vseobecna Fakultni Nemocnice V Praze
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Hopital Cote de Nacre
City
Caen
State/Province
Calvados
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Angers
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49100
Country
France
Facility Name
Centre Hospitalier Le Mans
City
Le Mans
ZIP/Postal Code
74000
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Universitatsklinikum Tubingen
City
Tubingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
4103
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Marien Hospital Akademisches Lehrkrankenhaus
City
Dusseldorf
ZIP/Postal Code
40479
Country
Germany
Facility Name
Laiko General Hospital of Athens
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Athens General Hospital 'G Gennimatas'
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
Attikon University General Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Facility Name
University Hospital of Alexandroupolis
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Facility Name
Laiko General Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital of Ioannina
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
University General Hospital of Patras
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
Georgios Papanikolaou General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah Medical Center PPDS -
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
Country
Israel
Facility Name
ZIV Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center PPDS
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
IRCCS Centro Di Riferimento Oncologico Della Basilicata
City
Rionero in Vulture
ZIP/Postal Code
85028
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital
City
Fukuyama
State/Province
Hirosima
ZIP/Postal Code
720-0001
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060 8638
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima-shi
State/Province
Hukusima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe-City
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Saitama Medical Center
City
Kawagoe
State/Province
Saitama
ZIP/Postal Code
3508550
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka-city
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Dokkyo Medical University Hospital
City
Mibu
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
8528102
Country
Japan
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama-shi
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
University of Fukui Hospital
City
Yoshida-gun
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Jeongnam
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Asan Medical Center - PPDS
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Samsung Medical Center - PPDS
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Facility Name
Hematologica Alta Especialidad S.C.
City
Huixquilucan
ZIP/Postal Code
52787
Country
Mexico
Facility Name
Capital Humano para Investigacion Clinica SC
City
Mexico
Country
Mexico
Facility Name
Instytut Hematologii i Transfuzjologii
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii I Transplantologii, Budynek Centrum Medycyny N
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Swietokrzyskie Centrum Onkologii
City
Kielce
State/Province
Swietokrzyskie
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiej
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Zaklad Diagnostyki Obrazowej SOR
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Facility Name
Szpital Wojewodzki w Opolu
City
Opole
ZIP/Postal Code
45-372
Country
Poland
Facility Name
City Clinical Hospital # 40
City
Moscow
ZIP/Postal Code
129301
Country
Russian Federation
Facility Name
North-West Federal Medical Research Center n.a. V.A. Almazov
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Russian Research Institute of Hematology and Blood Transfusion
City
St. Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
ICO lHospitalet Hospital Duran i Reynals
City
LHospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Complejo Asistencial Universitario de Leon
City
Leon
State/Province
Castilla Y Leon
ZIP/Postal Code
24071
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Paz - PPDS
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca - H. Clinico
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Gazi University Medical Faculty Gazi Hospital
City
Ankara
ZIP/Postal Code
6500
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Mersin University Medical Faculty
City
Mersin
ZIP/Postal Code
33343
Country
Turkey
Facility Name
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Namik Kemal University
City
Tekirdag
ZIP/Postal Code
59100
Country
Turkey
Facility Name
Karadeniz Technical University Faculty of Medicine
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Maidstone Hospital
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Singleton Hospital - PPDS
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Citations:
PubMed Identifier
35728048
Citation
Ades L, Girshova L, Doronin VA, Diez-Campelo M, Valcarcel D, Kambhampati S, Viniou NA, Woszczyk D, De Paz Arias R, Symeonidis A, Anagnostopoulos A, Munhoz EC, Platzbecker U, Santini V, Fram RJ, Yuan Y, Friedlander S, Faller DV, Sekeres MA. Pevonedistat plus azacitidine vs azacitidine alone in higher-risk MDS/chronic myelomonocytic leukemia or low-blast-percentage AML. Blood Adv. 2022 Sep 13;6(17):5132-5145. doi: 10.1182/bloodadvances.2022007334.
Results Reference
derived
Links:
URL
https://clinicaltrials.takeda.com/study-detail/5f6b60294db2bf003ab499ea
Description
Related Info

Learn more about this trial

Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)

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