A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
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.