Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Phase 1/2 Dose-Escalation Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Pediatric Patients With Refractory or Relapsed Acute Leukemias.
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the
treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute
lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This use is
based on the induction of complete responses. Randomized trials demonstrating increased
survival or other clinical benefit have not been conducted.
The purpose of the phase 1 portion of this study was to determine if clofarabine added to a
combination of etoposide and cyclophosphamide is safe in children with relapsed or
refractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). The
purpose of the phase 2 portion of the study was to measure the effectiveness of the
combination therapy in children with ALL.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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