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A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia

Primary Purpose

Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ponatinib
Imatinib
Vincristine
Dexamethasone
Cytarabine
Methotrexate
Prednisone
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL) focused on measuring Ponatinib, Imatinib mesylate, Bcr-Abl Tyrosine Kinase, Bcr-abl fusion proteins, Iclusig, Gleevec

Eligibility Criteria

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

Inclusion Criteria:

  1. Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2017 national comprehensive cancer network (NCCN) guidelines.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of <=2.

Exclusion Criteria:

  1. With a history or current diagnosis of chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML).
  2. Prior/current treatment with any systemic anticancer therapy (including but not limited to any tyrosine kinase inhibitor [TKI]) and/or radiotherapy for ALL, with the exception of an optional prephase therapy or chemotherapy induction (no more than 1 cycle), which should be discussed with the sponsor's medical monitor/designee.
  3. Currently taking drugs that are known to have a risk of causing prolonged corrected QT (QTc) or torsades de pointes (TdP) (unless these can be changed to acceptable alternatives or discontinued).
  4. Taking any medications or herbal supplements that are known to be strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4 within at least 14 days before the first dose of study drug.
  5. Uncontrolled active serious infection that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  6. Major surgery within 28 days before randomization (minor surgical procedures such as catheter placement or BM biopsy are not exclusionary criteria).
  7. Known human immunodeficiency virus (HIV) seropositivity, known active hepatitis B or C infection.
  8. History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis.
  9. Uncontrolled hypertriglyceridemia (triglycerides >450 milligram per deciliter [mg/dL]).
  10. Diagnosed and treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  11. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
  12. Clinical manifestations of CNS or extramedullary involvement with ALL other than lymphadenopathy or hepatosplenomegaly.
  13. Autoimmune disease with potential CNS involvement.
  14. Known significant neuropathy of Grade >=2 severity.
  15. Clinically significant, uncontrolled, or active cardiovascular, cerebrovascular, or peripheral vascular disease, or history of or active venous thrombotic/embolic event (VTE) disease.
  16. Have a significant bleeding disorder unrelated to ALL.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • City of Hope - DuarteRecruiting
  • University of California Los AngelesRecruiting
  • Augusta University Georgia Cancer CenterRecruiting
  • Indiana UniversityRecruiting
  • Indiana Blood & Marrow TransplantationRecruiting
  • University of Kansas Medical Center Research InstituteRecruiting
  • University of Maryland Medical CenterRecruiting
  • Hackensack University Medical CenterRecruiting
  • Roswell Park Cancer InstituteRecruiting
  • Monter Cancer CenterRecruiting
  • Stony Brook University Medical Center
  • Oregon Health and Science UniversityRecruiting
  • The University of Texas MD Anderson Cancer CenterRecruiting
  • Methodist HospitalRecruiting
  • Sanatorio AllendeRecruiting
  • Hospital Privado Centro Medico de CordobaRecruiting
  • Royal North Shore HospitalRecruiting
  • Box Hill HospitalRecruiting
  • Monash Medical CentreRecruiting
  • Ordensklinikum Linz ElisabethinenRecruiting
  • Hanusch Krankenhaus Wiener GebietskrankenkasseRecruiting
  • Universitaetsklinik Fuer Innere Medizin IRecruiting
  • Hospital Sao Rafael-Monte TaborRecruiting
  • Hospital Erasto GaertnerRecruiting
  • Hospital da CidadeRecruiting
  • Hospital de Clinicas de Porto AlegreRecruiting
  • Hemocentro Campinas UnicampRecruiting
  • Fundacao Doutor Amaral CarvalhoRecruiting
  • Hospital das Clinicas da Faculdade de Medicina da Riberao Preto da Universidade de Sao PauloRecruiting
  • HEMORIO Instituto Estadual de HematologiaRecruiting
  • Instituto do Cancer do Estado de Sao PauloRecruiting
  • Fundacao Antonio Prudente - A.C.Camargo Cancer CenterRecruiting
  • University Multiprofile Hospital for Active Treatment Saint Ivan RilskiRecruiting
  • 855 West 12th AvenueRecruiting
  • The Ottawa HospitalRecruiting
  • Hopital Charles-LeMoyneRecruiting
  • Hopital Maisonneuve-RosemontRecruiting
  • Henan Cancer HospitalRecruiting
  • The First Affiliated Hospital of Soochow University/Suzhou First People's HospitalRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • The First Affiliated Hospital, Zhejiang UniversityRecruiting
  • Institute of Hematology & Blood Diseases Hospital of CAMS & PUMCRecruiting
  • Helsingin ja Uudenmaan sairaanhoitopiiriRecruiting
  • Centre Hospitalier de Versailles Hopital Andre MignotRecruiting
  • Institut Universitaire du Cancer de Toulouse OncopoleRecruiting
  • Center Hospitalier Universitaire d'AngersRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Evaggelismos General HospitalRecruiting
  • University General Hospital of Athens AttikonRecruiting
  • University General Hospital of Patras Panagia I VoithiaRecruiting
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriRecruiting
  • Azienda Policlinico San MartinoRecruiting
  • Azienda Ospedaliera San Gerardo di MonzaRecruiting
  • Arcispedale Santa Maria NuovaRecruiting
  • Ospedale dell'AngeloRecruiting
  • Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-MalpighiRecruiting
  • Azienda Ospedaliera Vito FazziRecruiting
  • Istituto Scientifico Universitario San RaffaeleRecruiting
  • Azienda Ospedaliero-Universitaria di Modena PoliclinicoRecruiting
  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia-CervelloRecruiting
  • Azienda USL della RomagnaRecruiting
  • Centro di Ematologia Policlinico Umberto I Universita Sapienza di RomaRecruiting
  • Fondazione Policlinico Universitario Agostino GemelliRecruiting
  • National Cancer Center Hospital EastRecruiting
  • Aiiku HospitalRecruiting
  • Tokai University HospitalRecruiting
  • Okayama University HospitalRecruiting
  • Chiba Aoba Municipal HospitalRecruiting
  • Fukushima Medical University HospitalRecruiting
  • The Catholic University of Korea St. Vincent's HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Chonbuk National University HospitalRecruiting
  • Inje University Haeundae Paik HospitalRecruiting
  • Yeungnam University HospitalRecruiting
  • Hospital Universitario Dr. Jose Eleuterio GonzalezRecruiting
  • Uniwersytecki Szpital Kliniczny we WroclawiuRecruiting
  • Szpital Uniwersytecki w KrakowieRecruiting
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-MazursRecruiting
  • City Clinical Hospital named after Vikentiy Vikentyevich Veresaev
  • Sverdlovsk Regional Clinical Hospital #1
  • National Research Center for Hematology, Dept. of Hematology/Oncology and BMT
  • Almazov Federal North-West Medical Research Centre of Department of Health of Russian Federation
  • Institut Catala d'Oncologia Badalona - Hospital Germans Trias i PujolRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Hospital Universitari i Politecnic La Fe de ValenciaRecruiting
  • Hualien Tzu Chi HospitalRecruiting
  • China Medical University HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • Ankara Universitesi Tp Fakultesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cohort A: Ponatinib 30 milligram (mg)

Cohort B: Imatinib 600 mg

Arm Description

Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m^2 intravenous(IV), on Days 1 and 14 and dexamethasone 40 mg(<60 years [yrs]) and 20 mg (>=60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 for up to 3 cycles (each cycle will be of 28-days) in induction phase followed by ponatinib last dose of induction phase tablets, orally, QD, with cytarabine, 1000 mg/m^2 every 12 hours as a 2-hour IV infusion (<60 yrs) and 250 mg/m^2 every 12 hours (>=60 yrs), IV on Days 1, 3, and 5 of Cycles 2, 4, and 6, (cytarabine dose will be reduced/ discontinued in case of impaired renal function) and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (>=60 yrs), IV infusion, on Day 1 of cycles 1, 3, and 5 in consolidation phase followed by ponatinib last dose of consolidation phase, tablets, orally, QD, with vincristine 1.4 mg/m^2, IV, on Day 1 and prednisone 200 mg (<60 yrs), 100 mg (>=60-69 yrs) and 50 mg(>=70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase.

Imatinib 600 mg,tablets, orally,QD,along with vincristine 1.4 mg/m^2 (max 2 mg),IV,on Days 1 and 14 and dexamethasone 40 mg (<60 yrs) and 20 mg (≥60 yrs),orally,once on Days 1 through 4 and Days 11 through 14 in each 28-day cycle up to 3 cycles in induction phase followed by imatinib 600 mg,tablets,orally,QD, along with cytarabine, 1000 mg/m^2 every 12 hours as a 2-hour-IV infusion (<60 yrs) and 250 mg/m^2 every 12 hours (≥60 yrs), IV on Days 1,3, and 5 of each 28-day even cycles (Cycles 2,4,and 6), (cytarabine dose reduced/discontinued for participant with impaired renal function) and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (≥60 yrs),IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1,3,and 5) in consolidation phase followed by imatinib 600 mg,tablets,orally,QD, along with vincristine 1.4 mg/m^2 (max 2 mg),IV,on Day 1 and prednisone 200 mg (<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase.

Outcomes

Primary Outcome Measures

Number of Participants with Minimal Residual Disease (MRD)-Negative Complete Remission (CR)
MRD-negative CR is achieved when a participant meets the criteria for both MRD negativity and CR. MRD-negativity: less than or equal to (<=) 0.01 percent (%) breakpoint cluster region-Abelson (BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in complementary deoxyribonucleic acid (cDNA) with greater than or equal to (>=) 10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system [CNS] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) greater than (>) 1000 per micro liter (/mcL) (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L).

Secondary Outcome Measures

Event-free survival (EFS)
EFS is defined as the dates of randomization until death due to any cause or failure to achieve CR by end of induction or relapse from CR. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system [CNS] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) greater than (>) 1000 per micro liter (/mcL) (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L).Relapse from CR: reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR.
Percentage of Participants with CR and Incomplete Complete Remission (CRi)
CR is defined as meeting all the following for at least 4 weeks (that is, no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC.
Percentage of Participants with Molecular Response
Molecule response is assessed by 3-Log Reduction (MR3), Molecular Response 4-Log Reduction (MR4) and Molecular Response 4.5-Log Reduction (MR4.5). MR3 is defined as molecular response 3-log reduction (<=0.1% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=1000 ABL1 transcripts. MR4 is defined as molecular response 4-log reduction (<=0.01% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. MR4.5 is defined as Molecular response 4.5-log reduction (<=0.0032% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=32,000 ABL1 transcripts.
Percentage of Participants with Primary Induction Failure (PIF)
PIF is defined as participants who received treatment for ALL but never achieved CR or CRi by the end of induction. PIF is not limited by the number of unsuccessful treatments; this disease status only applies to recipients who have never been in CR or CRi. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC.
Percentage of Participants with Overall Response Rate (ORR)
ORR is defined as CR + CRi by end of induction. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC.
Percentage of MRD-Negative CR
MRD is defined as the percentage of participants achieving CR who are MRD-negative at multiple intervals after end of induction. MRD negativity: <=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. Relapse from CR: Reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR.
Duration of MRD-Negative CR
Duration of MRD-negative CR is defined as interval between the first assessment at which the criteria for MRD-negative CR are met until the earliest date at which loss of MRD negativity or relapse from CR occurs. MRD negativity (MR4): <=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. CR is defined as meeting all the following for at least 4 weeks (that is, no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). Relapse from CR: Reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR.
Duration of CR
Duration of CR is defined as interval between the first assessment at which the criteria for CR are met until the earliest date at which relapse from CR occurs. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). Relapse from CR: Reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR.
Time to Treatment Failure
Time to treatment failure is defined as time to end of study randomized treatment (except for hematopoietic stem cell transplantation [HSCT] without loss of MRD-negative CR) due to safety and efficacy reasons. MRD-negative CR is achieved when a participant meets the criteria for both MRD negativity and CR. MRD-negativity: <=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L).
Duration of MR4.5
Duration of MR4.5 is defined as interval between the first assessment at which the criteria for MR4.5 are met until the earliest date at which loss of MR4.5 occurs. MR4.5 is molecular response 4.5-log reduction (<=0.0032% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=32,000 ABL1 transcripts.
Percentage of On-Study Participants with Overall Survival (OS)
On-study participants with or without HSCT will be evaluated. OS is defined as interval between randomization and death due to any cause, censored at the last contact date when the participant was alive.
Percentage of On-Study Participants with Relapse From CR
On-study participants with or without HSCT will be evaluated. Relapse from CR is defined as reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR.
Overall Survival (OS)
OS is defined as interval between the randomization and death due to any cause, censored at the last contact date when the participant was alive.

Full Information

First Posted
July 5, 2018
Last Updated
November 9, 2022
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT03589326
Brief Title
A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
Official Title
A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
August 12, 2022 (Actual)
Study Completion Date
July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

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
In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib. The main aim of this study is to compare the number of participants on each treatment that show no signs of disease. Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study.
Detailed Description
The drug being tested in this study is called ponatinib. Ponatinib is being tested to treat people who have newly diagnosed Ph+ ALL. This study will look at the efficacy of ponatinib in participants in addition to standard care. The study will enroll approximately 230 participants. Participants will be randomized in a 2:1 ratio to receive oral ponatinib or imatinib (Cohort A and Cohort B, respectively) daily throughout the study. All participants will be asked to take ponatinib or imatinib at the same time each day with reduced-intensity chemotherapy in induction phase (Cycles 1 to 3), consolidation phase (Cycles 4 to 9) and maintenance phase (Cycles 10 to 20). At the end of the 20 cycles, participants will remain on ponatinib or imatinib (administered as a single agent). The dose of ponatinib in consolidation and maintenance phase will start with the last dose given in the previous phase. The dose can be modified based on MRD-negative CR results. This multi-center trial will be conducted in Argentina, Australia, Austria, Belarus, Brazil, Bulgaria, Canada, Chile, France, Mexico, Greece, Italy, Japan, Korea, Republic Of, Poland, Romania, Russia, Spain, Taiwan, Province Of China, Turkey, Finland and the United States. Participants including those who achieve a clinical response, may receive study drug until they are deceased, have failed to achieve the primary endpoint, have experienced relapse from CR or have progressive disease, have an unacceptable toxicity, have withdrawn consent, have proceeded to HSCT, or until the sponsor terminates the study, whichever occurs first. After disease progression, all participants will be contacted every 3 months for survival follow-up. Participants will be followed until completion of the study or until the participant's death has been reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
Keywords
Ponatinib, Imatinib mesylate, Bcr-Abl Tyrosine Kinase, Bcr-abl fusion proteins, Iclusig, Gleevec

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
It is an open-label trial, therefore investigators and participants are unblinded.
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: Ponatinib 30 milligram (mg)
Arm Type
Experimental
Arm Description
Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m^2 intravenous(IV), on Days 1 and 14 and dexamethasone 40 mg(<60 years [yrs]) and 20 mg (>=60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 for up to 3 cycles (each cycle will be of 28-days) in induction phase followed by ponatinib last dose of induction phase tablets, orally, QD, with cytarabine, 1000 mg/m^2 every 12 hours as a 2-hour IV infusion (<60 yrs) and 250 mg/m^2 every 12 hours (>=60 yrs), IV on Days 1, 3, and 5 of Cycles 2, 4, and 6, (cytarabine dose will be reduced/ discontinued in case of impaired renal function) and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (>=60 yrs), IV infusion, on Day 1 of cycles 1, 3, and 5 in consolidation phase followed by ponatinib last dose of consolidation phase, tablets, orally, QD, with vincristine 1.4 mg/m^2, IV, on Day 1 and prednisone 200 mg (<60 yrs), 100 mg (>=60-69 yrs) and 50 mg(>=70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase.
Arm Title
Cohort B: Imatinib 600 mg
Arm Type
Active Comparator
Arm Description
Imatinib 600 mg,tablets, orally,QD,along with vincristine 1.4 mg/m^2 (max 2 mg),IV,on Days 1 and 14 and dexamethasone 40 mg (<60 yrs) and 20 mg (≥60 yrs),orally,once on Days 1 through 4 and Days 11 through 14 in each 28-day cycle up to 3 cycles in induction phase followed by imatinib 600 mg,tablets,orally,QD, along with cytarabine, 1000 mg/m^2 every 12 hours as a 2-hour-IV infusion (<60 yrs) and 250 mg/m^2 every 12 hours (≥60 yrs), IV on Days 1,3, and 5 of each 28-day even cycles (Cycles 2,4,and 6), (cytarabine dose reduced/discontinued for participant with impaired renal function) and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (≥60 yrs),IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1,3,and 5) in consolidation phase followed by imatinib 600 mg,tablets,orally,QD, along with vincristine 1.4 mg/m^2 (max 2 mg),IV,on Day 1 and prednisone 200 mg (<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase.
Intervention Type
Drug
Intervention Name(s)
Ponatinib
Other Intervention Name(s)
Iclusig
Intervention Description
Ponatinib Tablets.
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
Gleevec
Intervention Description
Imatinib Tablets.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Vincristine IV injection.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone Tablets.
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
Cytarabine IV infusion.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate IV infusion.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone Tablets.
Primary Outcome Measure Information:
Title
Number of Participants with Minimal Residual Disease (MRD)-Negative Complete Remission (CR)
Description
MRD-negative CR is achieved when a participant meets the criteria for both MRD negativity and CR. MRD-negativity: less than or equal to (<=) 0.01 percent (%) breakpoint cluster region-Abelson (BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in complementary deoxyribonucleic acid (cDNA) with greater than or equal to (>=) 10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system [CNS] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) greater than (>) 1000 per micro liter (/mcL) (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L).
Time Frame
From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length is equal to [=] 28 days)
Secondary Outcome Measure Information:
Title
Event-free survival (EFS)
Description
EFS is defined as the dates of randomization until death due to any cause or failure to achieve CR by end of induction or relapse from CR. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system [CNS] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) greater than (>) 1000 per micro liter (/mcL) (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L).Relapse from CR: reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR.
Time Frame
Baseline up to approximately 3 to 6 years
Title
Percentage of Participants with CR and Incomplete Complete Remission (CRi)
Description
CR is defined as meeting all the following for at least 4 weeks (that is, no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC.
Time Frame
End of Cycle 1 (approximately 1 month), Cycle 2 (approximately 2 months), Cycle 3 (approximately 3 months), and Cycle 9 (approximately 9 months) (Cycle length= 28 days)
Title
Percentage of Participants with Molecular Response
Description
Molecule response is assessed by 3-Log Reduction (MR3), Molecular Response 4-Log Reduction (MR4) and Molecular Response 4.5-Log Reduction (MR4.5). MR3 is defined as molecular response 3-log reduction (<=0.1% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=1000 ABL1 transcripts. MR4 is defined as molecular response 4-log reduction (<=0.01% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. MR4.5 is defined as Molecular response 4.5-log reduction (<=0.0032% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=32,000 ABL1 transcripts.
Time Frame
End of Cycle 1 (approximately 1 month), Cycle 2 (approximately 2 months), Cycle 3 (approximately 3 months), and Cycle 9 (approximately 9 months) (Cycle length= 28 days)
Title
Percentage of Participants with Primary Induction Failure (PIF)
Description
PIF is defined as participants who received treatment for ALL but never achieved CR or CRi by the end of induction. PIF is not limited by the number of unsuccessful treatments; this disease status only applies to recipients who have never been in CR or CRi. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC.
Time Frame
Up to 3 months
Title
Percentage of Participants with Overall Response Rate (ORR)
Description
ORR is defined as CR + CRi by end of induction. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count and/or ANC.
Time Frame
Up to 3 months
Title
Percentage of MRD-Negative CR
Description
MRD is defined as the percentage of participants achieving CR who are MRD-negative at multiple intervals after end of induction. MRD negativity: <=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. Relapse from CR: Reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR.
Time Frame
Up to approximately 3 to 6 years
Title
Duration of MRD-Negative CR
Description
Duration of MRD-negative CR is defined as interval between the first assessment at which the criteria for MRD-negative CR are met until the earliest date at which loss of MRD negativity or relapse from CR occurs. MRD negativity (MR4): <=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. CR is defined as meeting all the following for at least 4 weeks (that is, no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). Relapse from CR: Reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR.
Time Frame
Up to approximately 3 to 6 years
Title
Duration of CR
Description
Duration of CR is defined as interval between the first assessment at which the criteria for CR are met until the earliest date at which relapse from CR occurs. CR is defined as meeting all the following for at least 4 weeks (that is no recurrence): 1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). Relapse from CR: Reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR.
Time Frame
Up to approximately 3 to 6 years
Title
Time to Treatment Failure
Description
Time to treatment failure is defined as time to end of study randomized treatment (except for hematopoietic stem cell transplantation [HSCT] without loss of MRD-negative CR) due to safety and efficacy reasons. MRD-negative CR is achieved when a participant meets the criteria for both MRD negativity and CR. MRD-negativity: <=0.01% BCR-ABL1/ABL1, or undetectable BCR-ABL1 transcripts in cDNA with >=10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and <5% blasts in the BM. 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (CNS involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. ANC >1000/mcL (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L).
Time Frame
Up to approximately 6 years
Title
Duration of MR4.5
Description
Duration of MR4.5 is defined as interval between the first assessment at which the criteria for MR4.5 are met until the earliest date at which loss of MR4.5 occurs. MR4.5 is molecular response 4.5-log reduction (<=0.0032% BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in cDNA with >=32,000 ABL1 transcripts.
Time Frame
Up to approximately 3 to 6 years
Title
Percentage of On-Study Participants with Overall Survival (OS)
Description
On-study participants with or without HSCT will be evaluated. OS is defined as interval between randomization and death due to any cause, censored at the last contact date when the participant was alive.
Time Frame
Up to approximately 3 to 6 years
Title
Percentage of On-Study Participants with Relapse From CR
Description
On-study participants with or without HSCT will be evaluated. Relapse from CR is defined as reappearance of blasts in the blood or BM (>=5%) or in any extramedullary site after a CR.
Time Frame
Up to approximately 3 to 6 years
Title
Overall Survival (OS)
Description
OS is defined as interval between the randomization and death due to any cause, censored at the last contact date when the participant was alive.
Time Frame
Up to approximately 3 to 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2017 national comprehensive cancer network (NCCN) guidelines. Eastern Cooperative Oncology Group (ECOG) performance status of <=2. Exclusion Criteria: With a history or current diagnosis of chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML). Prior/current treatment with any systemic anticancer therapy (including but not limited to any tyrosine kinase inhibitor [TKI]) and/or radiotherapy for ALL, with the exception of an optional prephase therapy or chemotherapy induction (no more than 1 cycle), which should be discussed with the sponsor's medical monitor/designee. Currently taking drugs that are known to have a risk of causing prolonged corrected QT (QTc) or torsades de pointes (TdP) (unless these can be changed to acceptable alternatives or discontinued). Taking any medications or herbal supplements that are known to be strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4 within at least 14 days before the first dose of study drug. Uncontrolled active serious infection that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. Major surgery within 28 days before randomization (minor surgical procedures such as catheter placement or BM biopsy are not exclusionary criteria). Known human immunodeficiency virus (HIV) seropositivity, known active hepatitis B or C infection. History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis. Uncontrolled hypertriglyceridemia (triglycerides >450 milligram per deciliter [mg/dL]). Diagnosed and treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Clinical manifestations of CNS or extramedullary involvement with ALL other than lymphadenopathy or hepatosplenomegaly. Autoimmune disease with potential CNS involvement. Known significant neuropathy of Grade >=2 severity. Clinically significant, uncontrolled, or active cardiovascular, cerebrovascular, or peripheral vascular disease, or history of or active venous thrombotic/embolic event (VTE) disease. Have a significant bleeding disorder unrelated to ALL.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Call center
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
205-934-9591
Email
pvachhani@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Pankit Vachhani
Facility Name
City of Hope - Duarte
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
626-256-4673
Email
ialdoss@coh.org
First Name & Middle Initial & Last Name & Degree
Ibrahim Aldoss
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
310-206-6909
Email
pyoung@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Patricia Young
Facility Name
Augusta University Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
706-721-6744
Email
vkota@augusta.edu
First Name & Middle Initial & Last Name & Degree
Vamsi Kota
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
317-274-3545
Email
lcripe@iupui.edu
First Name & Middle Initial & Last Name & Degree
Larry Cripe
Facility Name
Indiana Blood & Marrow Transplantation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
317-528-5500
Email
lakard@ibmtindy.com
First Name & Middle Initial & Last Name & Degree
Luke Akard
Facility Name
University of Kansas Medical Center Research Institute
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
585-957-4381
Email
hmale@kumc.edu
First Name & Middle Initial & Last Name & Degree
Heather Male
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
410-328-8708
Email
mbaer@umm.edu
First Name & Middle Initial & Last Name & Degree
Maria Baer
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
551-996-3049
Email
james.mccloskey@hackensackmeridian.org
First Name & Middle Initial & Last Name & Degree
James McCloskey
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
716-845-3544
Email
eunice.wang@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Eunice Wang
Facility Name
Monter Cancer Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
516-734-7606
Email
bgoldberg1@northwell.edu
First Name & Middle Initial & Last Name & Degree
Bradley Goldberg
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Completed
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
503-494-8211
Email
leonard@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Jessica Leonard
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
713-563-4553
Email
ejabbour@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Elias Jabbour
Facility Name
Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
210-575-3817
Email
jose.cruz@mhshealth.com
First Name & Middle Initial & Last Name & Degree
Jose Carlos Cruz
Facility Name
Sanatorio Allende
City
Cordoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+543514269285
Email
gjarchum@sanatorioallende.com
First Name & Middle Initial & Last Name & Degree
Gustavo Jarchum
Facility Name
Hospital Privado Centro Medico de Cordoba
City
Cordoba
ZIP/Postal Code
X5014KEH
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+543514688200
Email
ana.basquiera@hospitalprivado.com.ar
First Name & Middle Initial & Last Name & Degree
Ana Lisa Basquiera
Facility Name
Royal North Shore Hospital
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+61299264393
Email
matthew.greenwood@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Matthew Greenwood
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+61390949502
Email
a.schwarer@icloud.com
First Name & Middle Initial & Last Name & Degree
Anthony Schwarer
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+61408341855
Email
pasq.fedele@gmail.com
First Name & Middle Initial & Last Name & Degree
Pasquale Fedele
Facility Name
Ordensklinikum Linz Elisabethinen
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4373276764400
Email
sigrid.machherndl-spandl@ordensklinikum.at
First Name & Middle Initial & Last Name & Degree
Sigrid Machherndl-Spandl
Facility Name
Hanusch Krankenhaus Wiener Gebietskrankenkasse
City
Wien
State/Province
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4369917979717
Email
thamer.sliwa@wgkk.at
First Name & Middle Initial & Last Name & Degree
Thamer Sliwa
Facility Name
Universitaetsklinik Fuer Innere Medizin I
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+43014040044570
Email
alexander.hauswirth@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Alexander Hauswirth
Facility Name
Hospital Sao Rafael-Monte Tabor
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41253-190
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+557132816965
Email
marcohemato@hotmail.com
First Name & Middle Initial & Last Name & Degree
Marco Aurelio de Araujo
Facility Name
Hospital Erasto Gaertner
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+554133615195
Email
jf.cordeirocamargo@gmail.com
First Name & Middle Initial & Last Name & Degree
Johnny Francisco Camargo
Facility Name
Hospital da Cidade
City
Passo Fundo
State/Province
RIO Grande DO SUL
ZIP/Postal Code
99010-260
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+555433164064
Email
denisedeal@hotmail.com
First Name & Middle Initial & Last Name & Degree
Denise Almeida
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-003
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+555132148143
Email
fogliattopesquisa@gmail.com
First Name & Middle Initial & Last Name & Degree
Laura Maria Fogliatto
Facility Name
Hemocentro Campinas Unicamp
City
Campinas
State/Province
SAO Paulo
ZIP/Postal Code
130383-878
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+551935218740
Email
kborgia@unicamp.br
First Name & Middle Initial & Last Name & Degree
Katia Barbosa Pagnano
Facility Name
Fundacao Doutor Amaral Carvalho
City
Jau
State/Province
SAO Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+5514360213971526
Email
pesquisafac.edersonmattos@gmail.com
First Name & Middle Initial & Last Name & Degree
Ederson De Mattos
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Riberao Preto da Universidade de Sao Paulo
City
Ribeirao Preto
State/Province
SAO Paulo
ZIP/Postal Code
14048-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+551636022956
Email
lorenafigdo@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Lorena Pontes
Facility Name
HEMORIO Instituto Estadual de Hematologia
City
Rio de Janeiro
ZIP/Postal Code
20211-030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+5521233286112141
Email
diretor.tecnico@hemorio.rj.gov.br
First Name & Middle Initial & Last Name & Degree
Patricia Moura
Facility Name
Instituto do Cancer do Estado de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+551145737631
Email
vanderson.rocha@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Vanderson Rocha
Facility Name
Fundacao Antonio Prudente - A.C.Camargo Cancer Center
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+551121895017
Email
jayr.filho@accamargo.org.br
First Name & Middle Initial & Last Name & Degree
Jayr Schmidt Filho
Facility Name
University Multiprofile Hospital for Active Treatment Saint Ivan Rilski
City
Sofia
State/Province
Sofiya
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+359024034838
Email
aradinoff@hotmail.com
First Name & Middle Initial & Last Name & Degree
Atanas Radinoff
Facility Name
855 West 12th Avenue
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
1 (604) 875-4863
Email
ymourad@bccancer.bc.ca
First Name & Middle Initial & Last Name & Degree
Yasser Mourad
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
1 (613) 737-8899 ext: 71284
Email
jfulcher@toh.ca
First Name & Middle Initial & Last Name & Degree
Jill Fulcher
Facility Name
Hopital Charles-LeMoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
1 (450) 466-5000 ext: 3226
Email
pierre.desjardins@rrsss16.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Pierre Desjardins
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
1 (514) 252-3400
Email
juliebergeron.hmr@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Julie Bergeron
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613703904030
Email
jnyinqingsong@163.com
First Name & Middle Initial & Last Name & Degree
Qingsong Yin
Facility Name
The First Affiliated Hospital of Soochow University/Suzhou First People's Hospital
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8651267783686
Email
qiuhuiying@aliyun.com
First Name & Middle Initial & Last Name & Degree
Huiying Qiu
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8615843073208
Email
sujung1963@163.com
First Name & Middle Initial & Last Name & Degree
Sujun Gao
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+86057187236702
Email
jiej0503@163.com
First Name & Middle Initial & Last Name & Degree
Jie Jin
Facility Name
Institute of Hematology & Blood Diseases Hospital of CAMS & PUMC
City
Tianjin
ZIP/Postal Code
300041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613821389157
Email
wangjx@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Jianxiang Wang
Facility Name
Helsingin ja Uudenmaan sairaanhoitopiiri
City
Helsinki
ZIP/Postal Code
00029 HUS
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+3580947172338
Email
kimmo.porkka@helsinki.fi
First Name & Middle Initial & Last Name & Degree
Kimmo Porkka
Facility Name
Centre Hospitalier de Versailles Hopital Andre Mignot
City
Le Chesnay
State/Province
Ile-de-france
ZIP/Postal Code
78157
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+33139639133
Email
phrousselot@ch-versailles.fr
First Name & Middle Initial & Last Name & Degree
Philippe Rousselot
Facility Name
Institut Universitaire du Cancer de Toulouse Oncopole
City
Toulouse Cedex 09
State/Province
Midi-pyrenees
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+33531156269
Email
huguet.francoise@iuct-oncopole.fr
First Name & Middle Initial & Last Name & Degree
Francoise Huguet
Facility Name
Center Hospitalier Universitaire d'Angers
City
Angers Cedex 9
State/Province
PAYS DE LA Loire
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+33241354475
Email
mahunault@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Mathilde Hunault-Berger
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite Cedex
State/Province
Rhone-alpes
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+33478862250
Email
marie.balsat01@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Marie Balsat
Facility Name
Evaggelismos General Hospital
City
Athens
State/Province
Attica
ZIP/Postal Code
10676
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+302107201000
Email
mbouzani@yahoo.com
First Name & Middle Initial & Last Name & Degree
Maria Bouzani
Facility Name
University General Hospital of Athens Attikon
City
Chaidari
State/Province
Attica
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+302105832307
Email
vaspappa@med.uoa.gr
First Name & Middle Initial & Last Name & Degree
Vassiliki Pappa
Facility Name
University General Hospital of Patras Panagia I Voithia
City
Patra
State/Province
Peloponnese
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+302613603255
Email
argiris.symeonidis@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Argiris Symeonidis
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
State/Province
Forli-cesena
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390516364077
Email
giovanni.martinelli@irst.emr.it
First Name & Middle Initial & Last Name & Degree
Giovanni Martinelli
Facility Name
Azienda Policlinico San Martino
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+39105554316
Email
germana.beltrami@hsanmartino.it
First Name & Middle Initial & Last Name & Degree
Germana Beltrami
Facility Name
Azienda Ospedaliera San Gerardo di Monza
City
Monza
State/Province
Monza E Brianza
ZIP/Postal Code
20090
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390392339553
Email
carlo.gambacorti@unimib.it
First Name & Middle Initial & Last Name & Degree
Carlo Gambacorti Passerini
Facility Name
Arcispedale Santa Maria Nuova
City
Reggio Emilia
State/Province
Reggio Nella Emilia
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390522296822
Email
annalisa.imovilli@ausl.re.it
First Name & Middle Initial & Last Name & Degree
Annalisa Imovilli
Facility Name
Ospedale dell'Angelo
City
Mestre
State/Province
Venezia
ZIP/Postal Code
30174
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390419657362
Email
renato.bassan@aulss3.veneto.it
First Name & Middle Initial & Last Name & Degree
Renato Bassan
Facility Name
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390516363827
Email
cristina.papayannidis@gmail.com
First Name & Middle Initial & Last Name & Degree
Cristina Papayannidis
Facility Name
Azienda Ospedaliera Vito Fazzi
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390832661923
Email
direnzo.ematolecce@libero.it
First Name & Middle Initial & Last Name & Degree
Nicola Di Renzo
Facility Name
Istituto Scientifico Universitario San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390226431
Email
ciceri.clinicaltrials@hsr.it
First Name & Middle Initial & Last Name & Degree
Fabio Ciceri
Facility Name
Azienda Ospedaliero-Universitaria di Modena Policlinico
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+0594225570
Email
mario.luppi@unimore.it
First Name & Middle Initial & Last Name & Degree
Mario Luppi
Facility Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390917803164
Email
a.mule@villasofia.it
First Name & Middle Initial & Last Name & Degree
Antonino Mule
Facility Name
Azienda USL della Romagna
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390544285734
Email
francesco.lanza@auslromagna.it
First Name & Middle Initial & Last Name & Degree
Francesco Lanza
Facility Name
Centro di Ematologia Policlinico Umberto I Universita Sapienza di Roma
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+3906441639824
Email
chiaretti@bce.uniroma1.it
First Name & Middle Initial & Last Name & Degree
Sabina Chiaretti
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390630155300
Email
simona.sica@unicatt.it
First Name & Middle Initial & Last Name & Degree
Simona Sica
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81783825111
Email
jyuda@east.ncc.go.jp
First Name & Middle Initial & Last Name & Degree
Junichiro Yuda
Facility Name
Aiiku Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0804
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+810115632211
Email
t-kondoh@med.hokudai.ac.jp
First Name & Middle Initial & Last Name & Degree
Takeshi Kondo
Facility Name
Tokai University Hospital
City
Isehara City
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81463931121
Email
moni5@mac.com
First Name & Middle Initial & Last Name & Degree
Makoto Onizuka
Facility Name
Okayama University Hospital
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81862237151
First Name & Middle Initial & Last Name & Degree
Noboru Asada
Facility Name
Chiba Aoba Municipal Hospital
City
Chiba
ZIP/Postal Code
260-0852
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81432271131
First Name & Middle Initial & Last Name & Degree
Akira Yokota
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81245471111
Email
ikezoet@fmu.ac.jp
First Name & Middle Initial & Last Name & Degree
Takayuki Ikezoe
Facility Name
The Catholic University of Korea St. Vincent's Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+820312497114
Email
jakimapril@gmail.com
First Name & Middle Initial & Last Name & Degree
Jeong A Kim
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Gyeongsangbuk-do
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+82534205114
Email
knuhhema@gmail.com
First Name & Middle Initial & Last Name & Degree
Sang-Kyun Sohn
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+826325018605
Email
jykwak@chonbuk.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae-Yong Kwak
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+82 51 797 0661
Email
sungnaml@gmail.com
First Name & Middle Initial & Last Name & Degree
Sung-Nam Lim
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+82536204683
Email
kmk21c@medical.yu.ac.kr
First Name & Middle Initial & Last Name & Degree
Min Kyoung Kim
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+528183486136
Email
dgomezalmaguer@gmail.com
First Name & Middle Initial & Last Name & Degree
David Gomez Almaguer
Facility Name
Uniwersytecki Szpital Kliniczny we Wroclawiu
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-367
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48717842525
Email
a.czyz@umed.wroc.pl
First Name & Middle Initial & Last Name & Degree
Anna Czyz
Facility Name
Szpital Uniwersytecki w Krakowie
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48124247751
Email
sachatom@gmail.com
First Name & Middle Initial & Last Name & Degree
Tomasz Sacha
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48585844357
Email
wpre@gumed.edu.pl
First Name & Middle Initial & Last Name & Degree
Witold Prejzner
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurs
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-228
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48602120684
Email
janusz.halka@poliklinika.net
First Name & Middle Initial & Last Name & Degree
Janusz Halka
Facility Name
City Clinical Hospital named after Vikentiy Vikentyevich Veresaev
City
Moscow
State/Province
Moscow CITY
ZIP/Postal Code
127644
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Sverdlovsk Regional Clinical Hospital #1
City
Ekaterinburg
State/Province
Sverdlovsk
ZIP/Postal Code
620102
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
National Research Center for Hematology, Dept. of Hematology/Oncology and BMT
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Almazov Federal North-West Medical Research Centre of Department of Health of Russian Federation
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Institut Catala d'Oncologia Badalona - Hospital Germans Trias i Pujol
City
Badalona
State/Province
Cataluna
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34934978417
Email
jribera@iconcologia.net
First Name & Middle Initial & Last Name & Degree
Jose-Maria Ribera Santasusana
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+9374661004897
Email
pbarba@vhio.net
First Name & Middle Initial & Last Name & Degree
Pere Barba
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34923260402
Email
jmhr@usal.es
First Name & Middle Initial & Last Name & Degree
Jesus Maria Hernandez Rivas
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34961244925
Email
montesinos_pau@gva.es
First Name & Middle Initial & Last Name & Degree
Pau Montesinos
Facility Name
Hualien Tzu Chi Hospital
City
Hualien City
State/Province
Hualien
ZIP/Postal Code
970
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8863856182517602
Email
kevinlcc1234@gmail.com
First Name & Middle Initial & Last Name & Degree
Chi-Cheng Li
Facility Name
China Medical University Hospital
City
Taichung
State/Province
Taichung CITY
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8864220521215050
Email
lybai6@gmail.com
First Name & Middle Initial & Last Name & Degree
Li-Yuan Bai
Facility Name
National Cheng Kung University Hospital
City
Tainan
State/Province
Tainan CITY
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+886623535354559
Email
teresa@mail.ncku.edu.tw
First Name & Middle Initial & Last Name & Degree
Tsai-Yun Chen
Facility Name
Ankara Universitesi Tp Fakultesi
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Individual Site Status
Active, not recruiting

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/

Learn more about this trial

A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia

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