drugset / Trial / NCT01677949
Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |