drugset / Trial / NCT00067028

Clofarabine Combinations in Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS) and Myeloid Blast Phase Chronic Myeloid Leukemia (CML)

NCT00067028

RandomizedParallel-groupOpen-labelTreatment

Summary

The goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with Acute Myeloid Leukemia, high-grade MDS, or myeloid blast phase of Chronic Myeloid Leukemia who have relapsed following their initial therapy.

Timeline

Start
2003-12
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified 22.5 mg/m2 Intravenous
Subject Clofarabine Other / unclassified 40 mg/m2 Intravenous
Subject Cytarabine Small molecule 0.75 g Intravenous
Subject Cytarabine Small molecule 1 g Intravenous
Subject Idarubicin Small molecule 6 mg/m2 Intravenous
Subject Idarubicin Small molecule 10 mg/m2 Intravenous