drugset / Trial / NCT01677949

Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia

NCT01677949

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Study Design: This is a two-stage Phase II trial investigating the efficacy of Clofarabine, Cyclophosphamide and Etoposide in acute leukemia patients with detectable minimal residual disease (MRD) prior to allo-HCT. The primary objective is to determine the impact of the study treatment in eliminating the presence of minimal residual disease without causing a significant delay of allo-HCT due to treatment related toxicity. The intent of this study is to allow patients to proceed to transplant (independent of this study) within 42 days of Day 1 of Clofarabine based therapy.

Timeline

Start
2013-12
Primary completion
2016-01
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified 20 mg/m2 Intravenous
Subject Clofarabine Other / unclassified 30 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 300 mg/m2 Other
Subject Etoposide Small molecule 100 mg/m2 Intravenous