Phase II Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Status:
Completed
Trial end date:
2003-03-01
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 acute lymphoblastic leukemia
(ALL) who have had at least 2 prior treatment regimens.
This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with
refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be
refractory to one or two induction regimens, or have relapsed < one year from the date of
confirmation of the initial complete remission (CR). There will be two phases in this study -
an Induction phase and a Consolidation phase.