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Tyrosine Kinase Inhibitor

Ponatinib vs Imatinib for Acute Lymphoblastic Leukemia

Phase 3

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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

Known human immunodeficiency virus (HIV) seropositivity, known active hepatitis B or C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 to 6 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare the effectiveness of two different drugs, ponatinib and imatinib, in treating adults with a specific type of leukemia.

Who is the study for?

Adults newly diagnosed with Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who are in good enough health to perform daily activities with slight limitations (ECOG <=2). They can't join if they have HIV, hepatitis B or C, recent major surgery, certain heart diseases, other cancers within the last 5 years, severe nervous system conditions, or are taking specific drugs that affect liver enzymes or cause heart rhythm problems.

What is being tested?

The trial is testing Ponatinib against Imatinib in adults with Ph+ ALL. Participants will take one of these drugs as a pill every day along with less intense chemotherapy for up to 20 months and then continue just the pills unless they need to stop according to study rules.

What are the potential side effects?

Possible side effects include liver enzyme changes due to drug interactions, pancreatitis risk from Ponatinib; cardiovascular issues like blood clots; and potential nerve damage leading to pain or numbness. Both medications may also lower resistance to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukemia is newly diagnosed and positive for Philadelphia chromosome or BCR-ABL1.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no history of major brain-related health issues like epilepsy, stroke, or dementia.

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I have HIV or active hepatitis B or C.

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I have a bleeding disorder not caused by my leukemia.

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I have been diagnosed with chronic myeloid leukemia at any stage.

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I have had pancreatitis in the past year or suffer from chronic pancreatitis.

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I have an autoimmune disease that could affect my brain or spinal cord.

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I do not have uncontrolled heart, brain, or blood vessel problems, nor a history of blood clots.

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I experience significant nerve pain or numbness.

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My leukemia affects areas outside of my lymph nodes or liver/spleen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase

Secondary study objectives

Duration of CR

Duration of MR4.5

Duration of MRD-Negative CR

+10 more

Side effects data

From 2017 Phase 2 trial • 171 Patients • NCT01935336

67%

Grade 2 hypertension

67%

Grade 3 AE

100%

80%

60%

40%

20%

Study treatment Arm

Ponatinib SISH-/ISH+

Ponatinib SISH-/ISH-

Ponatinib SISH+/ISH+

Ponatinib SISH+/ISH-

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cohort A: Ponatinib 30 milligram (mg)Experimental Treatment6 Interventions

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.

Group II: Cohort B: Imatinib 600 mgActive Control6 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Ponatinib

2015

Completed Phase 2

~830

Vincristine

2003

Completed Phase 4

~2970