Trial · NCT03589326
A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
NCT03589326, Phase 3, Active not recruiting, Takeda; results first posted 2023-10-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia. Trials, record NCT03589326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03589326
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
- NCT number
- NCT03589326
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 245 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
- Interventions
- Ponatinib, Imatinib, Vincristine, Dexamethasone, Cytarabine, Methotrexate, Prednisone
- First posted
- 2018-07-17
- Last updated
- 2025-11-26
- Results first posted
- 2023-10-27
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase | From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length = 28 days) | 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). |
| Secondary | Event-free Survival (EFS) | Baseline up to approximately 3 to 6 years | 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. |
| Secondary | Percentage of Participants With CR and Incomplete Complete Remission (CRi) | 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) | 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. |
| Secondary | Percentage of Participants With Molecular Response | 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) | 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. |
| Secondary | Percentage of Participants With Primary Induction Failure (PIF) | Up to 3 months | 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. |
| Secondary | Percentage of Participants With Overall Response Rate (ORR) | Up to 3 months | 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. |
| Secondary | Percentage of MRD-Negative CR | Up to approximately 3 to 6 years | 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. |
| Secondary | Duration of MRD-Negative CR | Up to approximately 3 to 6 years | 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. |
| Secondary | Duration of CR | Up to approximately 3 to 6 years | 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. |
| Secondary | Time to Treatment Failure | Up to approximately 6 years | 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). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase | From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length = 28 days) | ITT population with p190/p210 variant was defined as all participants in the ITT population who were identified by the central laboratory as having baseline breakpoint cluster region-Abelson1 (BCR-ABL1) dominant variants of p190 or p210. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Event-free Survival (EFS) | Baseline up to approximately 3 to 6 years | |||
| SECONDARY | Percentage of Participants With CR and Incomplete Complete Remission (CRi) | 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) | |||
| SECONDARY | Percentage of Participants With Molecular Response | 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) | |||
| SECONDARY | Percentage of Participants With Primary Induction Failure (PIF) | Up to 3 months | |||
| SECONDARY | Percentage of Participants With Overall Response Rate (ORR) | Up to 3 months | |||
| SECONDARY | Percentage of MRD-Negative CR | Up to approximately 3 to 6 years | |||
| SECONDARY | Duration of MRD-Negative CR | Up to approximately 3 to 6 years | |||
| SECONDARY | Duration of CR | Up to approximately 3 to 6 years | |||
| SECONDARY | Time to Treatment Failure | Up to approximately 6 years |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase | Cohort A: Ponatinib 30 mg | 53 | Participants | ||
| Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase | Cohort B: Imatinib 600 mg | 13 | Participants |
Source ClinicalTrials.gov
Participant flow22
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| IP (Cycles 1-3) (Cycle Length=28 Days) | STARTED | Cohort A: Ponatinib 30 mg | 164 | |
| IP (Cycles 1-3) (Cycle Length=28 Days) | STARTED | Cohort B: Imatinib 600 mg | 81 | |
| IP (Cycles 1-3) (Cycle Length=28 Days) | Efficacy Evaluable Population | Cohort A: Ponatinib 30 mg | 154 | |
| IP (Cycles 1-3) (Cycle Length=28 Days) | Efficacy Evaluable Population | Cohort B: Imatinib 600 mg | 78 | |
| IP (Cycles 1-3) (Cycle Length=28 Days) | Safety Population | Cohort A: Ponatinib 30 mg | 163 | |
| IP (Cycles 1-3) (Cycle Length=28 Days) | Safety Population | Cohort B: Imatinib 600 mg | 81 | |
| IP (Cycles 1-3) (Cycle Length=28 Days) | COMPLETED | Cohort A: Ponatinib 30 mg | 0 | |
| IP (Cycles 1-3) (Cycle Length=28 Days) | COMPLETED | Cohort B: Imatinib 600 mg | 0 | |
| IP (Cycles 1-3) (Cycle Length=28 Days) | NOT COMPLETED | Cohort A: Ponatinib 30 mg | 164 | |
| IP (Cycles 1-3) (Cycle Length=28 Days) | NOT COMPLETED | Cohort B: Imatinib 600 mg | 81 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 participant flowAdverse events438
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | Cohort A: Ponatinib 30 mg | 67 | 163 | |
| other | Alanine aminotransferase increased | Investigations | Cohort B: Imatinib 600 mg | 27 | 81 | |
| other | Lipase increased | Investigations | Cohort A: Ponatinib 30 mg | 44 | 163 | |
| other | Lipase increased | Investigations | Cohort B: Imatinib 600 mg | 29 | 81 | |
| other | Platelet count decreased | Investigations | Cohort A: Ponatinib 30 mg | 39 | 163 | |
| other | Platelet count decreased | Investigations | Cohort B: Imatinib 600 mg | 26 | 81 | |
| other | Neutrophil count decreased | Investigations | Cohort A: Ponatinib 30 mg | 34 | 163 | |
| other | Neutrophil count decreased | Investigations | Cohort B: Imatinib 600 mg | 26 | 81 | |
| other | Aspartate aminotransferase increased | Investigations | Cohort A: Ponatinib 30 mg | 39 | 163 | |
| other | Aspartate aminotransferase increased | Investigations | Cohort B: Imatinib 600 mg | 15 | 81 |
1 to 10 of 438Source ClinicalTrials.gov
See all 438 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: Ponatinib 30 mg | 21 | 163 |
| Total, all-cause mortality | Cohort B: Imatinib 600 mg | 13 | 81 |
| Total, other adverse events | Cohort A: Ponatinib 30 mg | 159 | 163 |
| Total, other adverse events | Cohort B: Imatinib 600 mg | 80 | 81 |
| Total, serious adverse events | Cohort A: Ponatinib 30 mg | 97 | 163 |
| Total, serious adverse events | Cohort B: Imatinib 600 mg | 45 | 81 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A: Ponatinib 30 mg vs Cohort B: Imatinib 600 mg: deaths from any cause | Trial comparisons |
| Cohort A: Ponatinib 30 mg vs Cohort B: Imatinib 600 mg: Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase | Trial comparisons |
| Cohort A: Ponatinib 30 mg vs Cohort B: Imatinib 600 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03589326
GET https://conductscience.org/api/trials/v1/NCT03589326/flow?page=2