drugset / Trial / NCT01289457

Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome

NCT01289457

Phase 1/2 Completed 282 enrolled M.D. Anderson Cancer Center
RandomizedSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can help control Acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS). The safety of these study drug combinations will also be studied.

Timeline

Start
2011-02-02
Primary completion
2017-06-28
Completion
2017-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified 15 mg/m2 Intravenous
Subject Cytarabine Small molecule 1 g Intravenous
Subject Fludarabine Small molecule 30 mg/m2 Intravenous
Subject Idarubicin Small molecule 10 mg/m2 Intravenous

Indications