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A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)


A Phase III Randomized, Double-Blind, Controlled Study Comparing Clofarabine and Cytarabine Versus Cytarabine Alone in Adult Patients 55 Years and Older With Acute Myelogenous Leukemia (AML) Who Have Relapsed or Are Refractory After Receiving up to Two Prior Induction Regimens




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. There is no recommended standard treatment for relapsed or refractory acute myelogenous leukemia in patients older than 59 years. Cytarabine is the most commonly used drug to treat these patients. This study will determine if there is additional benefit by combining clofarabine with cytarabine.

Study Status: Recruiting


Condition Intervention Phase
Acute Myelogenous Leukemia Drug: clofarabine (IV formulation) and cytarabine
Drug: placebo and cytarabine
Phase 3

Verified by Genzyme July, 2008

Sponsored by: Genzyme
Information provided by: Genzyme identifier: NCT00317642

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Cleveland Clinic Florida
Weston, Florida 33331
United States


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