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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 to 6 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My leukemia is newly diagnosed and positive for Philadelphia chromosome or BCR-ABL1.
Select...
I can take care of myself but might not be able to do heavy physical work.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase
Secondary outcome measures
Duration of CR
Duration of MR4.5
Duration of MRD-Negative CR
+10 moreSide effects data
From 2017 Phase 2 trial • 171 Patients • NCT0193533667%
Grade 2 hypertension
67%
Grade 3 AE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ponatinib SISH-/ISH+
Ponatinib SISH-/ISH-
Ponatinib SISH+/ISH+
Ponatinib SISH+/ISH-
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
~820
Vincristine
2003
Completed Phase 4
~2910
Dexamethasone
2007
Completed Phase 4
~2590
Cytarabine
2016
Completed Phase 3
~3310
Methotrexate
2013
Completed Phase 4
~3800
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,177,771 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,210 Previous Clinical Trials
489,244 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no history of major brain-related health issues like epilepsy, stroke, or dementia.I have HIV or active hepatitis B or C.I have a bleeding disorder not caused by my leukemia.I do not have any serious infections that could interfere with my treatment.I have not taken strong CYP3A4 inhibitors or inducers in the last 14 days.I have been diagnosed with chronic myeloid leukemia at any stage.I have received cancer treatment for ALL, but only a limited initial treatment as allowed.I haven't had major surgery in the last 28 days.I have had pancreatitis in the past year or suffer from chronic pancreatitis.I haven't had another cancer, except for non-dangerous skin cancer or fully removed in-situ carcinoma, in the last 5 years.My leukemia is newly diagnosed and positive for Philadelphia chromosome or BCR-ABL1.I am not on medication that risks heart rhythm issues, or I can switch.I have an autoimmune disease that could affect my brain or spinal cord.I do not have uncontrolled heart, brain, or blood vessel problems, nor a history of blood clots.I can take care of myself but might not be able to do heavy physical work.I experience significant nerve pain or numbness.My leukemia affects areas outside of my lymph nodes or liver/spleen.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: Ponatinib 30 milligram (mg)
- Group 2: Cohort B: Imatinib 600 mg
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled spots in this trial that patients could take advantage of?
"That is correct. The trial, which was originally posted on August 10th 2018 and updated November 9th 2020, is still recruiting patients from the 21 different sites. They are looking for a total of 230 individuals to enroll in the study."
Answered by AI
Has Ponatinib been cleared by the FDA?
"Ponatinib has received a Phase 3 safety rating from our team at Power. This is due to the presence of data supporting Ponatinib's efficacy as well as multiple rounds of data affirming its safety."
Answered by AI
How many total individuals are taking part in this experiment?
"The clinical trial is currently ongoing, with the most recent update on patient recruitment happening on 11/9/2022. The study needs to recruit 230 individuals from 21 different medical facilities."
Answered by AI
How many different medical clinics are participating in this study?
"So far, this clinical trial has recruited 21 patients from locations including Duarte, Winnipeg, and Birmingham."
Answered by AI
For what purpose is Ponatinib most commonly prescribed?
"Ponatinib is effective in the treatment of pheochromocytomas as well as other conditions such as eye, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."
Answered by AI
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