Leukemia, Myelocytic, Acute, Pediatric Clinical Trial
Official title:
A Phase II, Open Label Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the
treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia
(ALL) who have had at least 2 prior treatment regimens.
The purpose of this study is to determine whether Clofarabine is safe and effective in the
treatment of Acute Myelogenous Leukemia (AML.)
This is a non-randomized, open label, Phase II study of Clofarabine in pediatric patients with refractory or relapsed acute myelogenous leukemia (AML). Eligible patients must be in first or subsequent relapse or be refractory. Forty eligible patients will be enrolled in a Fleming 2-stage sequential study design in order to better assess the efficacy and safety of clofarabine in this patient population. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00125840 -
Clofarabine in Adult Patients With Advanced Solid Tumors
|
Phase 1 |