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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03589326
Registration number
NCT03589326
Ethics application status
Date submitted
5/07/2018
Date registered
17/07/2018
Date last updated
27/10/2023
Titles & IDs
Public title
A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
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Scientific 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)
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Secondary ID [1]
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2018-000397-30
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Secondary ID [2]
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Ponatinib-3001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
0
0
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0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
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0
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Children's - Leukaemia & Lymphoma
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Cancer
0
0
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ponatinib
Treatment: Drugs - Imatinib
Treatment: Drugs - Vincristine
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Cytarabine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Prednisone
Experimental: Cohort A: Ponatinib 30 milligram (mg) - Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m^2 (max 2 mg) 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, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m^2 as 2-hour IV infusion (<60 yrs) and 250 mg/m^2 (=60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m^2 (<60 yrs) and 250 mg/m^2 (=60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase followed by ponatinib last consolidation phase dose 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 to 5 for up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022.
Active Comparator: Cohort B: Imatinib 600 mg - Imatinib 600 mg, tablets, orally, QD, 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 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, 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 each 28-day even cycles (Cycles 2, 4, and 6), 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 up to data cut-off date: 12 August 2022.
Treatment: Drugs: Ponatinib
Ponatinib Tablets.
Treatment: Drugs: Imatinib
Imatinib Tablets.
Treatment: Drugs: Vincristine
Vincristine IV injection.
Treatment: Drugs: Dexamethasone
Dexamethasone Tablets.
Treatment: Drugs: Cytarabine
Cytarabine IV infusion.
Treatment: Drugs: Methotrexate
Methotrexate IV infusion.
Treatment: Drugs: Prednisone
Prednisone Tablets.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase
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Assessment method [1]
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MRD-negative CR was achieved when a participant met the criteria for both MRD negativity and CR. MRD-negativity: =0.01 % breakpoint cluster region-Abelson (BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in complementary deoxyribonucleic acid (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 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) > 1000 per microliter (/mcL) (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L).
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Timepoint [1]
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From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length = 28 days)
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Secondary outcome [1]
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Event-free Survival (EFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to approximately 3 to 6 years
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Secondary outcome [2]
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Percentage of Participants With CR and Incomplete Complete Remission (CRi)
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Assessment method [2]
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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.
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Timepoint [2]
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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)
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Secondary outcome [3]
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Percentage of Participants With Molecular Response
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Assessment method [3]
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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.
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Timepoint [3]
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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)
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Secondary outcome [4]
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Percentage of Participants With Primary Induction Failure (PIF)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 3 months
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Secondary outcome [5]
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Percentage of Participants With Overall Response Rate (ORR)
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Assessment method [5]
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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.
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Timepoint [5]
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0
Up to 3 months
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Secondary outcome [6]
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Percentage of MRD-Negative CR
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Assessment method [6]
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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.
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Timepoint [6]
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0
Up to approximately 3 to 6 years
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Secondary outcome [7]
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Duration of MRD-Negative CR
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Assessment method [7]
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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.
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Timepoint [7]
0
0
Up to approximately 3 to 6 years
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Secondary outcome [8]
0
0
Duration of CR
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Assessment method [8]
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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.
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Timepoint [8]
0
0
Up to approximately 3 to 6 years
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Secondary outcome [9]
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Time to Treatment Failure
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Assessment method [9]
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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).
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Timepoint [9]
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Up to approximately 6 years
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Secondary outcome [10]
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Duration of MR4.5
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Assessment method [10]
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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.
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Timepoint [10]
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Up to approximately 3 to 6 years
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Secondary outcome [11]
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Percentage of On-Study Participants With Overall Survival (OS)
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Assessment method [11]
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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.
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Timepoint [11]
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Up to approximately 3 to 6 years
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Secondary outcome [12]
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Percentage of On-Study Participants With Relapse From CR
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Assessment method [12]
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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.
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Timepoint [12]
0
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Up to approximately 3 to 6 years
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Secondary outcome [13]
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Overall Survival (OS)
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Assessment method [13]
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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.
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Timepoint [13]
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Up to approximately 3 to 6 years
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/10/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/07/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
245
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal North Shore Hospital - Saint Leonards
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Recruitment hospital [2]
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Box Hill Hospital - Box Hill
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Recruitment hospital [3]
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Monash Medical Centre - Clayton
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Recruitment postcode(s) [1]
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2065 - Saint Leonards
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Recruitment postcode(s) [2]
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3128 - Box Hill
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Alabama
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United States of America
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California
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Georgia
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Maryland
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United States of America
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New Jersey
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United States of America
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New York
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Oregon
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Texas
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Argentina
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Cordoba
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Austria
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Upper Austria
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Austria
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Vienna
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Brazil
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Bahia
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Brazil
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Parana
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Brazil
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RIO Grande DO SUL
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Brazil
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SAO Paulo
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Bulgaria
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Sofiya
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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China
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Henan
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China
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Jiangsu
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China
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Jilin
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China
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Zhejiang
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China
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Tianjin
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Finland
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Helsinki
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Ile-de-france
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France
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Midi-pyrenees
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France
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PAYS DE LA Loire
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France
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Italy
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Italy
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Liguria
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Italy
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Monza E Brianza
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Italy
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Reggio Nella Emilia
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Italy
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Venezia
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Italy
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Bologna
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Lecce
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Italy
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Milano
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Modena
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Italy
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Palermo
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Italy
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Italy
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Roma
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Country [48]
0
0
Japan
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State/province [48]
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0
Chiba
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Country [49]
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0
Japan
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State/province [49]
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0
Hokkaido
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Country [50]
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Japan
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Kanagawa
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Country [51]
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Japan
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Okayama
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Japan
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Fukushima
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Country [53]
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeongsangbuk-do
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Country [55]
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Korea, Republic of
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Jeollabuk-do
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Country [56]
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Korea, Republic of
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Busan
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Country [57]
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Korea, Republic of
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Daegu
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Country [58]
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Mexico
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Nuevo LEON
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Country [59]
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Poland
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Dolnoslaskie
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Country [60]
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Poland
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State/province [60]
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Malopolskie
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Country [61]
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Poland
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State/province [61]
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Pomorskie
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Country [62]
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Poland
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Warminsko-mazurskie
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Country [63]
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Russian Federation
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State/province [63]
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Moscow CITY
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Country [64]
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Russian Federation
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State/province [64]
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Sverdlovsk
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Country [65]
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Russian Federation
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Moscow
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Country [66]
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Russian Federation
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Saint Petersburg
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Country [67]
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Spain
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Cataluna
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Country [68]
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Spain
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Barcelona
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Country [69]
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Spain
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State/province [69]
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Salamanca
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Country [70]
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Spain
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Valencia
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Country [71]
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Taiwan
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State/province [71]
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Hualien
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Country [72]
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Taiwan
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State/province [72]
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Taichung CITY
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Country [73]
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Taiwan
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State/province [73]
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Tainan CITY
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Country [74]
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Turkey
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State/province [74]
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Ankara
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Takeda
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03589326
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Public notes
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Contacts
Principal investigator
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Study Director
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Address
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Takeda
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03589326
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