At a glance
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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)
In Brief
A Phase 3 clinical trial evaluating Ponatinib, Imatinib, and 5 other interventions for Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL). Active but no longer recruiting, targeting 245 participants across 92 sites in 20 countries.
Detailed 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.
Study Details
Timeline
Interventions
Ponatinib Tablets.
Imatinib Tablets.
Vincristine IV injection.
Dexamethasone Tablets.
Cytarabine IV infusion.
Methotrexate IV infusion.
Prednisone Tablets.