Use the hyperlinks, where available to access additional clinical trial information.
A Pivotal Phase 1/2, Single-Arm, Open-label Study to Evaluate the Safety and Efficacy of Ponatinib With Chemotherapy in Pediatric Patients With Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy, or Who Have the T315I Mutation
Eligible patients will asked to take ponatinib once daily. In phase 1 ponatinib will be administered in combination with chemotherapy to determine the recommended phase 2 dose (RP2D) of ponatinib. In both phase 1 and phase 2, treatment consists of two 35-day blocks of therapy (reinduction block and consolidation block). Each block will include 29 days of treatment of daily ponatinib and chemotherapy, followed by a rest period from chemotherapy for a minimum of 6 days, during which time patients will receive daily ponatinib only.