A Phase 1/2, Multi-center, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination with Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric
The purpose of this study is to find the best dose of Quizartinib that can be given safely with chemotherapy in children and young adults with acute myeloid leukemia (AML) which has come back or has not responded to the standard therapy. Quizartinib will be given by mouth once a day from Day 6 through Day 28. It will be given in combination with chemptherapy drugs cytarabine and fludarabine.
Are you Eligible? (Inclusion Criteria)
- Patients must have recurrent or refractory AML
- Patients must be between 1 month and ≤21 years of age
- Patients must also meet all eligibility criteria as outlined in the study protocol