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Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome (Verona)

Primary Purpose

Myelodysplastic Syndrome (MDS)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Venetoclax
Azacitidine
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome (MDS) focused on measuring MDS, Myelodysplastic Syndrome, Venetoclax, Azacitidine, AZA, Venclexta

Eligibility Criteria

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

Inclusion Criteria:

  • Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016 World Health Organization (WHO) classification wtih presence of < 20% bone marrow blasts per marrow biopsy/aspirate at screening.

  • Participants must meet the following disease activity criteria:

    • Overall Revised International Prognostic Scoring System (IPSS-R) score > 3 (intermediate, high or very high).
    • Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
    • Hematopoietic stem cell transplant (HSCT) eligible with no pre-arranged HSCT at the time of Study Day 1, or HSCT ineligible without plan for HSCT at the time of Study Day 1.

Exclusion Criteria:

  • Prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogenic stem cell transplantation.
  • Prior diagnosis of therapy-related MDS (t-MDS), MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.

Sites / Locations

  • Providence Medical Foundation /ID# 222633
  • University of California, Los Angeles /ID# 221760
  • Torrance Memorial Physician Network Cancer Care /ID# 222702
  • PIH Health Whittier Hospital /ID# 222647
  • Rocky Mountain Cancer Centers /ID# 223723
  • Yale University /ID# 222764
  • Helen F. Graham Cancer Center & Research Institute /ID# 223731
  • Florida Cancer Specialists - Fort Myers /ID# 221319
  • Memorial Healthcare System /ID# 222703
  • Florida Cancer Specialists - North /ID# 221318
  • Florida Cancer Specialists - Panhandle /ID# 221315
  • Florida Cancer Specialists - East /ID# 221317
  • St. Luke's Mountain State Tumor Institute /ID# 220838
  • Northwestern University Feinberg School of Medicine /ID# 220843
  • Rush University Medical Center /ID# 221007
  • Ingalls Memorial Hosp /ID# 220844
  • Illinois Cancer Care, PC /ID# 220840
  • Parkview Cancer Institute /ID# 223620
  • Cancer Center of Kansas /ID# 222648
  • Hematology/Oncology Clinic /ID# 224257
  • Pontchartrain Cancer Center - Covington /ID# 221005
  • Maryland Oncology Hematology /ID# 223776
  • Massachusetts General Hospital /ID# 225068
  • Beth Israel Deaconess Medical Center /ID# 225069
  • Dana-Farber Cancer Institute /ID# 219162
  • VA Ann Arbor Healthcare System /ID# 221365
  • Cancer & Hematology Centers /ID# 220848
  • Mmcorc /Id# 221321
  • MidAmerica Division, Inc. /ID# 221895
  • Comprehensive Cancer Centers of Nevada - Horizon Ridge /ID# 222635
  • Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 221003
  • The Valley Hospital /ID# 232337
  • New York Oncology Hematology - Albany Cancer Center /ID# 223778
  • University at Buffalo /ID# 221206
  • Weill Cornell Medical College /ID# 222898
  • Stony Brook University Hospital /ID# 224450
  • Novant Health Presbyterian Medical Center /ID# 222561
  • Novant Health Forsyth Medical Center /ID# 221004
  • Oncology Hematology Care, Inc. /ID# 223724
  • Bend Memorial Clinic /ID# 220999
  • Willamette Valley Cancer Institute and Research Center /ID# 223733
  • UPMC Hillman Cancer Ctr /ID# 223201
  • Avera Cancer Institute /ID# 243461
  • Tennessee Oncology - Chattanooga / McCallie /ID# 221311
  • Tennessee Oncology-Nashville Centennial /ID# 220854
  • Texas Oncology - Austin Midtown /ID# 223729
  • Texas Oncology - Medical City Dallas /ID# 223725
  • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 223727
  • Texas Oncology - Forth Worth /ID# 223777
  • MD Anderson Cancer Center at Texas Medical Center /ID# 219163
  • Texas Oncology - San Antonio Medical Center /ID# 223728
  • Baylor Scott & White Medical Center- Temple /ID# 221332
  • Texas Oncology - Northeast Texas /ID# 223734
  • Utah Cancer Specialists Salt Lake Clinic /ID# 219160
  • Virginia Cancer Specialists - Gainesville /ID# 223726
  • Virginia Commonwealth University Medical Center Main Hospital /ID# 221590
  • Virginia Cancer Institute at Reynolds Crossing /ID# 221002
  • VA Puget Sound Health Care System /ID# 221358
  • Blacktown Hospital /ID# 234079
  • St George Hospital /ID# 221810
  • Port Macquarie Base Hospital /ID# 234078
  • Gold coast University Hospital /ID# 222606
  • Royal Adelaide Hospital /ID# 221805
  • St Vincent's Hospital Melbourne /ID# 221809
  • Austin Health /ID# 221807
  • Ordensklinikum Linz GmbH Elisabethinen /ID# 221387
  • Klinikum Wels-Grieskirchen GmbH /ID# 221386
  • Medizinische Universitaet Wien /ID# 221446
  • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 221092
  • Hanusch Krankenhaus /ID# 221093
  • UCL Saint-Luc /ID# 219066
  • CHU UCL Namur - site Godinne /ID# 219064
  • UZ Gent /ID# 218767
  • Universitair Ziekenhuis Leuven /ID# 218905
  • ZNA Middelheim /ID# 218907
  • AZ Sint-Jan Brugge /ID# 218212
  • Pôle Hospitalier Jolimont /ID# 218921
  • Hospital Universitario Walter Cantidio /ID# 223434
  • Liga Paranaense de Combate ao Câncer /ID# 221341
  • Sociedade Beneficente Israelita Hospital Albert Einstein /ID# 221370
  • Hospital Universitário Pedro Ernesto /ID# 223080
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 221339
  • BC Cancer - Surrey /ID# 219098
  • Ottawa Hospital Research Institute /ID# 219105
  • Sunnybrook Health Sciences Ctr /ID# 219103
  • McGill University Health Center Research Institute /ID# 222519
  • CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 218973
  • CHUQ- Hôpital de l'Enfant-Jesus /ID# 221200
  • Guangdong Provincial People's Hospital /ID# 221442
  • Zhujiang Hospital of Southern Medical University /ID# 222071
  • Nanfang Hospital of Southern Medical University /ID# 224566
  • The Second Hospital of Hebei Medical University /ID# 222919
  • Henan Provincial People's Hospital /ID# 225790
  • Henan Cancer Hospital /ID# 221447
  • Tongji Hospital Tongji Medical College of HUST /ID# 221474
  • Zhongda Hospital Southeast University /ID# 221849
  • Jiangsu Province Hospital /ID# 221342
  • The First Affiliated Hospital of Soochow University /ID# 221640
  • The First Affiliated Hospital of Nanchang University /ID# 225983
  • Shaanxi Provincial people's Hospital /ID# 225728
  • Shanghai Sixth People's Hospital /ID# 221546
  • West China Hospital, Sichuan University /ID# 221601
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 221567
  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 221494
  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 225982
  • The Fourth Affiliated Hospital Zhejiang University School of Medicine /ID# 225918
  • Peking University International Hospital /ID# 222987
  • Lanzhou University Second Hospital /ID# 225980
  • Shengjing Hospital of China Medical University /ID# 222945
  • Tianjin Medical University General Hospital /ID# 226810
  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 221475
  • Fakultni Nemocnice Brno /ID# 221351
  • Fakultni nemocnice Hradec Kralove /ID# 221163
  • Fakultni nemocnice Ostrava /ID# 219143
  • Fakultni nemocnice Plzen /ID# 221162
  • Ustav hematologie a krevni transfuze /ID# 221350
  • Vseobecna fakultni nemocnice v Praze /ID# 221229
  • CHU de Nice - Hôpital Archet 1 /ID# 220992
  • CHU Bordeaux - Hopital Haut Leveque /ID# 220989
  • CHRU Lille - Hopital Claude Huriez /ID# 220991
  • CHU de Nantes, Hotel Dieu -HME /ID# 222074
  • CH Henri Duffaut /ID# 225185
  • CHU Grenoble - Hopital Michallon /ID# 220988
  • AP-HM - Hopital de la Conception /ID# 224882
  • AP-HP - Hopital Saint-Louis /ID# 222075
  • Centre Henri Becquerel /ID# 220986
  • Universitatsklinikum Mannheim /ID# 221172
  • Stauferklinikum Schwaebisch Gmuend /ID# 224917
  • Universitaetsklinikum Duesseldorf /ID# 221169
  • Universitaetsklinikum Koeln /ID# 234219
  • Universitaetsklinikum Leipzig /ID# 221168
  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 221189
  • Medizinische Hochschule Hannover /ID# 221173
  • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221170
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221705
  • Fejer Megyei Szent Gyorgy Korhaz /ID# 222953
  • Debreceni Egyetem Klinikai Kozpont /ID# 221702
  • Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 221703
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 221704
  • The Chaim Sheba Medical Center /ID# 221110
  • Tel Aviv Sourasky Medical Center /ID# 221896
  • Hadassah Medical Center-Hebrew University /ID# 222006
  • Rambam Health Care Campus /ID# 221083
  • Shaare Zedek Medical Center /ID# 233181
  • Rabin Medical Center /ID# 221184
  • Istituto Clinico Humanitas /ID# 220815
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220810
  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 220816
  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 220818
  • Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 220819
  • Nagoya University Hospital /ID# 221566
  • University of Fukui Hospital /ID# 221568
  • Kyushu University Hospital /ID# 223473
  • Fukushima Medical University Hospital /ID# 222015
  • Chugoku Central Hospital /ID# 222955
  • Sapporo Hokuyu Hospital /ID# 222133
  • Aiiku Hospital /ID# 222351
  • Kobe City Medical Center General Hospital /ID# 221977
  • National Hospital Organization Mito Medical Center /ID# 222278
  • Tohoku University Hospital /ID# 221976
  • Nagasaki University Hospital /ID# 222241
  • Okayama Medical Center /ID# 222310
  • Kindai University Hospital /ID# 222284
  • Saitama Medical Center /ID# 222016
  • NTT Medical Center Tokyo /ID# 222365
  • Yamagata University Hospital /ID# 221574
  • Seoul National University Bundang Hospital /ID# 221695
  • Yonsei University Health System Severance Hospital /ID# 233171
  • Pusan National University Hospital /ID# 232353
  • Seoul National University Hospital /ID# 221226
  • Asan Medical Center /ID# 221227
  • Samsung Medical Center /ID# 221224
  • Erasmus Medisch Centrum /ID# 218937
  • Maxima Medisch Centrum /ID# 223010
  • Medisch Spectrum Twente /ID# 223012
  • Maastricht Universitair Medisch Centrum /ID# 221630
  • Isala /ID# 223011
  • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 233321
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221784
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 221667
  • LUX MED Onkologia - Szpital Szamocka /ID# 222203
  • Uniwersyteckie Centrum Kliniczne /ID# 222069
  • Pratia Onkologia Katowice /ID# 224728
  • MTZ Clinical Research Powered by Pratia /ID# 221354
  • Pan American Center for Oncology Trials, LLC /ID# 221010
  • VA Caribbean Healthcare System /ID# 221012
  • Kaluga Regional Clinical Hospital /ID# 221211
  • Clinic UZI 4D /ID# 221215
  • Hospital n.a. V.V. Veresaev /ID# 225435
  • MMCC Kommunarka /ID# 221213
  • Republican hospital named after V.A. Baranov /ID# 221214
  • Almazov National Medical Research Centre /ID# 221449
  • Hospital Universitario Germans Trias i Pujol /ID# 221274
  • Hospital Universitario Quironsalud Madrid /ID# 221275
  • Hospital Universitario Vall d'Hebron /ID# 221323
  • Hospital Universitario Reina Sofia /ID# 221273
  • Hospital General Universitario Gregorio Maranon /ID# 221271
  • Hospital Universitario 12 de Octubre /ID# 221272
  • Hospital Universitario de Salamanca /ID# 221297
  • Hospital Universitario Virgen del Rocio /ID# 221276
  • Hospital Universitario y Politecnico La Fe /ID# 221270
  • Kaohsiung Chang Gung Memorial Hospital /ID# 223573
  • China Medical University Hospital /ID# 218987
  • National Cheng Kung University Hospital /ID# 218989
  • Chi-Mei Medical Center /ID# 218991
  • Erciyes University Medical Fac /ID# 222090
  • Hacettepe University Faculty of Medicine /ID# 222094
  • Ankara City Hospital /ID# 222093
  • Akdeniz Universitesi Tip Fakul /ID# 222095
  • Ondokuz mayis University Facul /ID# 222091
  • Acibadem Maslak Hastanesi /ID# 222072
  • University Hospitals Bristol NHS Foundation Trust /ID# 222510
  • Oxford University Hospitals NHS Foundation Trust /ID# 221231
  • Cardiff & Vale University Health Board /ID# 221236
  • NHS Grampian /ID# 222509
  • University Hospitals Birmingham NHS Foundation Trust /ID# 221233
  • University College London Hospitals NHS Foundation Trust /ID# 221240
  • The Royal Marsden NHS Foundation Trust /ID# 221232
  • University Hospital Plymouth NHS Trust /ID# 222514
  • University Hospitals Dorset NHS Foundation Trust /ID# 221237

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: Venetoclax + Azacitidine (AZA)

Arm 2: Placebo + Azacitidine

Arm Description

Participants will receive venetoclax once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.

Participants will receive placebo once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.

Outcomes

Primary Outcome Measures

Overall survival (OS)
OS is defined as the number of days from the date of randomization to the date of death of any cause, or last known date to be alive.

Secondary Outcome Measures

Modified Overall Response (mOR)
mOR [complete remission (CR) + marrow complete remission (mCR) + partial response (PR)] is defined as achieving a CR, mCR, or PR at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).
Percentage of Participants Achieving Overall Hematological Improvement (HI)
Overall HI is defined as achieving the response of HI-platelet or HI-neutrophil, or HI-erythroid at any time point during the study prior to post-treatment therapy per the modified IWG 2006 criteria for MDS.
Complete Remission (CR)
CR is defined as achieving a complete remission at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).
Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline
TI is when the participants who were transfusion dependent on red blood cell (RBC) and/or Platelet at baseline achieve transfusion independence post baseline. TI is a period of at least 56 days with no transfusion after the date of the first dose of study drug to the last dose of study drug + 30 days, or 1 day before the date of progressive disease/ relapse from CR or PR per the modified IWG 2006 criteria for MDS, or 1 day before the initiation of post-treatment therapy or 1 day before death, whichever is earliest.
Time to Deterioration in Physical Functioning as Measured by Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scale
Time to deterioration in physical functioning, as measured by the EORTC QLQ-C30 physical functioning score is defined as the time from the date of randomization to the date of death of any cause, or the first time worsening of score from baseline >= a pre-specified threshold. Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form (SF) 7a Scale Score
Fatigue will be assessed using the PROMIS Fatigue SF 7a Global Fatigue Score. PROMIS Fatigue SF 7a is a 7-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. Participants rate items on a 5-point scale, with 1 as "never" an 5 as "always".
Overall Response (OR)
OR [complete remission (CR) + partial response (PR)] is defined as achieving a CR or PR at any time point during the study per the modified IWG 2006 criteria for MDS.

Full Information

First Posted
May 22, 2020
Last Updated
April 24, 2023
Sponsor
AbbVie
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04401748
Brief Title
Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome
Acronym
Verona
Official Title
A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Azacitidine in Patients Newly Diagnosed With Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
February 14, 2025 (Anticipated)
Study Completion Date
February 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS. Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide. Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome (MDS)
Keywords
MDS, Myelodysplastic Syndrome, Venetoclax, Azacitidine, AZA, Venclexta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
531 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Venetoclax + Azacitidine (AZA)
Arm Type
Experimental
Arm Description
Participants will receive venetoclax once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.
Arm Title
Arm 2: Placebo + Azacitidine
Arm Type
Active Comparator
Arm Description
Participants will receive placebo once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199, GDC-0199, Venclexta
Intervention Description
Tablet: Oral
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Other Intervention Name(s)
AZA
Intervention Description
Subcutaneous (SC) or Intravenous (IV) injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet; Oral
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS is defined as the number of days from the date of randomization to the date of death of any cause, or last known date to be alive.
Time Frame
Up To 5 Years
Secondary Outcome Measure Information:
Title
Modified Overall Response (mOR)
Description
mOR [complete remission (CR) + marrow complete remission (mCR) + partial response (PR)] is defined as achieving a CR, mCR, or PR at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).
Time Frame
Up To 5 Years
Title
Percentage of Participants Achieving Overall Hematological Improvement (HI)
Description
Overall HI is defined as achieving the response of HI-platelet or HI-neutrophil, or HI-erythroid at any time point during the study prior to post-treatment therapy per the modified IWG 2006 criteria for MDS.
Time Frame
Up to 5 Years
Title
Complete Remission (CR)
Description
CR is defined as achieving a complete remission at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).
Time Frame
Up To 36 Months
Title
Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline
Description
TI is when the participants who were transfusion dependent on red blood cell (RBC) and/or Platelet at baseline achieve transfusion independence post baseline. TI is a period of at least 56 days with no transfusion after the date of the first dose of study drug to the last dose of study drug + 30 days, or 1 day before the date of progressive disease/ relapse from CR or PR per the modified IWG 2006 criteria for MDS, or 1 day before the initiation of post-treatment therapy or 1 day before death, whichever is earliest.
Time Frame
Up To 5 Years
Title
Time to Deterioration in Physical Functioning as Measured by Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scale
Description
Time to deterioration in physical functioning, as measured by the EORTC QLQ-C30 physical functioning score is defined as the time from the date of randomization to the date of death of any cause, or the first time worsening of score from baseline >= a pre-specified threshold. Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Time Frame
Up To 5 Years
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form (SF) 7a Scale Score
Description
Fatigue will be assessed using the PROMIS Fatigue SF 7a Global Fatigue Score. PROMIS Fatigue SF 7a is a 7-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. Participants rate items on a 5-point scale, with 1 as "never" an 5 as "always".
Time Frame
Up To 5 Years
Title
Overall Response (OR)
Description
OR [complete remission (CR) + partial response (PR)] is defined as achieving a CR or PR at any time point during the study per the modified IWG 2006 criteria for MDS.
Time Frame
Up To 5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016 World Health Organization (WHO) classification wtih presence of < 20% bone marrow blasts per marrow biopsy/aspirate at screening. Participants must meet the following disease activity criteria: Overall Revised International Prognostic Scoring System (IPSS-R) score > 3 (intermediate, high or very high). Eastern Cooperative Oncology Group (ECOG) performance status of <= 2. Hematopoietic stem cell transplant (HSCT) eligible with no pre-arranged HSCT at the time of Study Day 1, or HSCT ineligible without plan for HSCT at the time of Study Day 1. Exclusion Criteria: Prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogenic stem cell transplantation. Prior diagnosis of therapy-related MDS (t-MDS), MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Providence Medical Foundation /ID# 222633
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
University of California, Los Angeles /ID# 221760
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Torrance Memorial Physician Network Cancer Care /ID# 222702
City
Torrance
State/Province
California
ZIP/Postal Code
90505-5004
Country
United States
Facility Name
PIH Health Whittier Hospital /ID# 222647
City
Whittier
State/Province
California
ZIP/Postal Code
90602-1006
Country
United States
Facility Name
Rocky Mountain Cancer Centers /ID# 223723
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Yale University /ID# 222764
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Helen F. Graham Cancer Center & Research Institute /ID# 223731
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713-2055
Country
United States
Facility Name
Florida Cancer Specialists - Fort Myers /ID# 221319
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Memorial Healthcare System /ID# 222703
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021-3513
Country
United States
Facility Name
Florida Cancer Specialists - North /ID# 221318
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705-1449
Country
United States
Facility Name
Florida Cancer Specialists - Panhandle /ID# 221315
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308-5304
Country
United States
Facility Name
Florida Cancer Specialists - East /ID# 221317
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
St. Luke's Mountain State Tumor Institute /ID# 220838
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712-6267
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine /ID# 220843
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
Rush University Medical Center /ID# 221007
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Ingalls Memorial Hosp /ID# 220844
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Illinois Cancer Care, PC /ID# 220840
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Parkview Cancer Institute /ID# 223620
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845-1739
Country
United States
Facility Name
Cancer Center of Kansas /ID# 222648
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Hematology/Oncology Clinic /ID# 224257
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Pontchartrain Cancer Center - Covington /ID# 221005
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433-7512
Country
United States
Facility Name
Maryland Oncology Hematology /ID# 223776
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044-3128
Country
United States
Facility Name
Massachusetts General Hospital /ID# 225068
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 225069
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Dana-Farber Cancer Institute /ID# 219162
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
VA Ann Arbor Healthcare System /ID# 221365
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Cancer & Hematology Centers /ID# 220848
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mmcorc /Id# 221321
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
MidAmerica Division, Inc. /ID# 221895
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Horizon Ridge /ID# 222635
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052-2648
Country
United States
Facility Name
Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 221003
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
The Valley Hospital /ID# 232337
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
New York Oncology Hematology - Albany Cancer Center /ID# 223778
City
Albany
State/Province
New York
ZIP/Postal Code
12206-5013
Country
United States
Facility Name
University at Buffalo /ID# 221206
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
Weill Cornell Medical College /ID# 222898
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University Hospital /ID# 224450
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8183
Country
United States
Facility Name
Novant Health Presbyterian Medical Center /ID# 222561
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Novant Health Forsyth Medical Center /ID# 221004
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Oncology Hematology Care, Inc. /ID# 223724
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236-2725
Country
United States
Facility Name
Bend Memorial Clinic /ID# 220999
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Willamette Valley Cancer Institute and Research Center /ID# 223733
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401-6043
Country
United States
Facility Name
UPMC Hillman Cancer Ctr /ID# 223201
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Avera Cancer Institute /ID# 243461
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Tennessee Oncology - Chattanooga / McCallie /ID# 221311
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404-3230
Country
United States
Facility Name
Tennessee Oncology-Nashville Centennial /ID# 220854
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States
Facility Name
Texas Oncology - Austin Midtown /ID# 223729
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Oncology - Medical City Dallas /ID# 223725
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 223727
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-2003
Country
United States
Facility Name
Texas Oncology - Forth Worth /ID# 223777
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-2150
Country
United States
Facility Name
MD Anderson Cancer Center at Texas Medical Center /ID# 219163
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4000
Country
United States
Facility Name
Texas Oncology - San Antonio Medical Center /ID# 223728
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240-5251
Country
United States
Facility Name
Baylor Scott & White Medical Center- Temple /ID# 221332
City
Temple
State/Province
Texas
ZIP/Postal Code
76508-0001
Country
United States
Facility Name
Texas Oncology - Northeast Texas /ID# 223734
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Utah Cancer Specialists Salt Lake Clinic /ID# 219160
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Virginia Cancer Specialists - Gainesville /ID# 223726
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155-3257
Country
United States
Facility Name
Virginia Commonwealth University Medical Center Main Hospital /ID# 221590
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Virginia Cancer Institute at Reynolds Crossing /ID# 221002
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
VA Puget Sound Health Care System /ID# 221358
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108-1597
Country
United States
Facility Name
Blacktown Hospital /ID# 234079
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
St George Hospital /ID# 221810
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Port Macquarie Base Hospital /ID# 234078
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Gold coast University Hospital /ID# 222606
City
SouthPort
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Royal Adelaide Hospital /ID# 221805
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
St Vincent's Hospital Melbourne /ID# 221809
City
Fitzroy Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Austin Health /ID# 221807
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Ordensklinikum Linz GmbH Elisabethinen /ID# 221387
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH /ID# 221386
City
Wels
State/Province
Oberoesterreich
ZIP/Postal Code
4600
Country
Austria
Facility Name
Medizinische Universitaet Wien /ID# 221446
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 221092
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Hanusch Krankenhaus /ID# 221093
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
UCL Saint-Luc /ID# 219066
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU UCL Namur - site Godinne /ID# 219064
City
Godinne
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
UZ Gent /ID# 218767
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven /ID# 218905
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
ZNA Middelheim /ID# 218907
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
AZ Sint-Jan Brugge /ID# 218212
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Pôle Hospitalier Jolimont /ID# 218921
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Hospital Universitario Walter Cantidio /ID# 223434
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-372
Country
Brazil
Facility Name
Liga Paranaense de Combate ao Câncer /ID# 221341
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Sociedade Beneficente Israelita Hospital Albert Einstein /ID# 221370
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Facility Name
Hospital Universitário Pedro Ernesto /ID# 223080
City
Rio de Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 221339
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
BC Cancer - Surrey /ID# 219098
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
Ottawa Hospital Research Institute /ID# 219105
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Ctr /ID# 219103
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
McGill University Health Center Research Institute /ID# 222519
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 218973
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
CHUQ- Hôpital de l'Enfant-Jesus /ID# 221200
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Guangdong Provincial People's Hospital /ID# 221442
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Zhujiang Hospital of Southern Medical University /ID# 222071
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Facility Name
Nanfang Hospital of Southern Medical University /ID# 224566
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The Second Hospital of Hebei Medical University /ID# 222919
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Henan Provincial People's Hospital /ID# 225790
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Henan Cancer Hospital /ID# 221447
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Tongji Hospital Tongji Medical College of HUST /ID# 221474
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Zhongda Hospital Southeast University /ID# 221849
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Jiangsu Province Hospital /ID# 221342
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The First Affiliated Hospital of Soochow University /ID# 221640
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215031
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University /ID# 225983
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Shaanxi Provincial people's Hospital /ID# 225728
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Shanghai Sixth People's Hospital /ID# 221546
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
West China Hospital, Sichuan University /ID# 221601
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 221567
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 221494
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 225982
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310020
Country
China
Facility Name
The Fourth Affiliated Hospital Zhejiang University School of Medicine /ID# 225918
City
Yiwu
State/Province
Zhejiang
ZIP/Postal Code
322000
Country
China
Facility Name
Peking University International Hospital /ID# 222987
City
Beijing
ZIP/Postal Code
102206
Country
China
Facility Name
Lanzhou University Second Hospital /ID# 225980
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Facility Name
Shengjing Hospital of China Medical University /ID# 222945
City
Shenyang
ZIP/Postal Code
110022
Country
China
Facility Name
Tianjin Medical University General Hospital /ID# 226810
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 221475
City
Wuhan
ZIP/Postal Code
420022
Country
China
Facility Name
Fakultni Nemocnice Brno /ID# 221351
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove /ID# 221163
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava /ID# 219143
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice Plzen /ID# 221162
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Ustav hematologie a krevni transfuze /ID# 221350
City
Praha
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze /ID# 221229
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
CHU de Nice - Hôpital Archet 1 /ID# 220992
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
CHU Bordeaux - Hopital Haut Leveque /ID# 220989
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 220991
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 222074
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Facility Name
CH Henri Duffaut /ID# 225185
City
Avignon CEDEX 9
State/Province
Vaucluse
ZIP/Postal Code
84902
Country
France
Facility Name
CHU Grenoble - Hopital Michallon /ID# 220988
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
AP-HM - Hopital de la Conception /ID# 224882
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
AP-HP - Hopital Saint-Louis /ID# 222075
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Henri Becquerel /ID# 220986
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Universitatsklinikum Mannheim /ID# 221172
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Stauferklinikum Schwaebisch Gmuend /ID# 224917
City
Mutlangen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73557
Country
Germany
Facility Name
Universitaetsklinikum Duesseldorf /ID# 221169
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitaetsklinikum Koeln /ID# 234219
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsklinikum Leipzig /ID# 221168
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 221189
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Medizinische Hochschule Hannover /ID# 221173
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221170
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221705
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korhaz /ID# 222953
City
Szekesfehervar
State/Province
Fejer
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 221702
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 221703
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 221704
City
Nyiregyhaza
State/Province
Szabolcs-Szatmar-Bereg
ZIP/Postal Code
4400
Country
Hungary
Facility Name
The Chaim Sheba Medical Center /ID# 221110
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 221896
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Hadassah Medical Center-Hebrew University /ID# 222006
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 221083
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center /ID# 233181
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Rabin Medical Center /ID# 221184
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Istituto Clinico Humanitas /ID# 220815
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220810
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 220816
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 220818
City
Reggio Calabria
ZIP/Postal Code
89124
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 220819
City
Rome
ZIP/Postal Code
00189
Country
Italy
Facility Name
Nagoya University Hospital /ID# 221566
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4668560
Country
Japan
Facility Name
University of Fukui Hospital /ID# 221568
City
Yoshida-gun
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Kyushu University Hospital /ID# 223473
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Fukushima Medical University Hospital /ID# 222015
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Chugoku Central Hospital /ID# 222955
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
720-0001
Country
Japan
Facility Name
Sapporo Hokuyu Hospital /ID# 222133
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0006
Country
Japan
Facility Name
Aiiku Hospital /ID# 222351
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
064-0804
Country
Japan
Facility Name
Kobe City Medical Center General Hospital /ID# 221977
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
National Hospital Organization Mito Medical Center /ID# 222278
City
Higashi Ibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Tohoku University Hospital /ID# 221976
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Nagasaki University Hospital /ID# 222241
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Okayama Medical Center /ID# 222310
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Kindai University Hospital /ID# 222284
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Saitama Medical Center /ID# 222016
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
NTT Medical Center Tokyo /ID# 222365
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Yamagata University Hospital /ID# 221574
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Seoul National University Bundang Hospital /ID# 221695
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Yonsei University Health System Severance Hospital /ID# 233171
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Pusan National University Hospital /ID# 232353
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 221226
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 221227
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 221224
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Erasmus Medisch Centrum /ID# 218937
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Maxima Medisch Centrum /ID# 223010
City
Eindhoven
ZIP/Postal Code
5631 BM
Country
Netherlands
Facility Name
Medisch Spectrum Twente /ID# 223012
City
Enschede
ZIP/Postal Code
7512 KZ
Country
Netherlands
Facility Name
Maastricht Universitair Medisch Centrum /ID# 221630
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Isala /ID# 223011
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 233321
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221784
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 221667
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-081
Country
Poland
Facility Name
LUX MED Onkologia - Szpital Szamocka /ID# 222203
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-748
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne /ID# 222069
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Pratia Onkologia Katowice /ID# 224728
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Facility Name
MTZ Clinical Research Powered by Pratia /ID# 221354
City
Warszawa
ZIP/Postal Code
02-172
Country
Poland
Facility Name
Pan American Center for Oncology Trials, LLC /ID# 221010
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
VA Caribbean Healthcare System /ID# 221012
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
Facility Name
Kaluga Regional Clinical Hospital /ID# 221211
City
Kaluga
State/Province
Kaluzhskaya Oblast
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
Clinic UZI 4D /ID# 221215
City
Pyatigorsk
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Hospital n.a. V.V. Veresaev /ID# 225435
City
Moscow
ZIP/Postal Code
127644
Country
Russian Federation
Facility Name
MMCC Kommunarka /ID# 221213
City
Moscow
ZIP/Postal Code
129301
Country
Russian Federation
Facility Name
Republican hospital named after V.A. Baranov /ID# 221214
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Almazov National Medical Research Centre /ID# 221449
City
Sankt-Peterburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Hospital Universitario Germans Trias i Pujol /ID# 221274
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Quironsalud Madrid /ID# 221275
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron /ID# 221323
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Reina Sofia /ID# 221273
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 221271
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 221272
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario de Salamanca /ID# 221297
City
Salamanca
ZIP/Postal Code
37711
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio /ID# 221276
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 221270
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Kaohsiung Chang Gung Memorial Hospital /ID# 223573
City
Kaohsiung City
State/Province
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
China Medical University Hospital /ID# 218987
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital /ID# 218989
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Chi-Mei Medical Center /ID# 218991
City
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
Erciyes University Medical Fac /ID# 222090
City
Melikgazi
State/Province
Kayseri
ZIP/Postal Code
38030
Country
Turkey
Facility Name
Hacettepe University Faculty of Medicine /ID# 222094
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara City Hospital /ID# 222093
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Akdeniz Universitesi Tip Fakul /ID# 222095
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Ondokuz mayis University Facul /ID# 222091
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Facility Name
Acibadem Maslak Hastanesi /ID# 222072
City
Tuzla
ZIP/Postal Code
34953
Country
Turkey
Facility Name
University Hospitals Bristol NHS Foundation Trust /ID# 222510
City
Bristol
State/Province
Bristol, City Of
ZIP/Postal Code
BS1 3NU
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust /ID# 221231
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Cardiff & Vale University Health Board /ID# 221236
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
NHS Grampian /ID# 222509
City
Aberdeen
ZIP/Postal Code
AB15 6RE
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust /ID# 221233
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust /ID# 221240
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust /ID# 221232
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
University Hospital Plymouth NHS Trust /ID# 222514
City
Plymouth
ZIP/Postal Code
PL6 5FP
Country
United Kingdom
Facility Name
University Hospitals Dorset NHS Foundation Trust /ID# 221237
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Learn more about this trial

Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

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