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)
This study is being done to answer the following question:
Is ponatinib more effective than imatinib in patients with Acute Lymphoblastic Leukemia (ALL)?
Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL)
-Age 18 or older
-You have been newly diagnosed with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL)
18 - n/a
Healthy Volunteers Needed
Duration of Participation
The duration that you will take study drug or imatinib will depend on your response and tolerance to the drug you are receiving. You may stop receiving either study drug or imatinib if you will undergo stem-cell transplantation. After you stop taking the study drug, you will be followed to see if you are alive and well, and to assess the status of your disease. For this survival follow-up, you will be contacted every 3 months (+/- 14 days) until death has been reported.
Your investigator will assess your individual response to the study drug and your participation may be longer or shorter than the estimated average.
Clinical Trials Information Line
Millenium Pharmaceuticals, Inc (A wholly owned subsidiary of Takeda Pharmaceutical Company Limited)