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
Elizabeth Martin
Primary Investigator
Brief description of study
The primary objective of the study is to compare the efficacy of ponatinib versus imatinib, administered as first-line therapy in combination with reduced-intensity chemotherapy, in patients with newly diagnosed Ph+ ALL, as measured by the MRD-negative CR rate at the end of induction
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
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Age: Between 18 Years - 100 Years
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Gender: All
In order to be eligible to take part in this trial, patients must meet the following criteria:
- Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2017 national comprehensive cancer network (NCCN) guidelines.
- Cannot have any active serious infection requiring antibiotics within 14 days before the first dose of study drug.
For a full list of participation criteria, please visit clinicaltrials.gov.
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