drugset / Trial / NCT02349178

Bridging Study to Eliminate Presence of MRD for Acute Leukemia Before HCT

NCT02349178

NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 2 study designed for the purpose of estimating various parameters surrounding the efficacy of Clofarabine, Cyclophosphamide and Etoposide in eliminating minimal residual disease (MRD) in acute leukemia patients otherwise in remission and without causing significant delay of HCT due to treatment related toxicity. A single course of "bridge" chemotherapy is given prior to the transplant procedure as an approach to improved disease-free survival in a patient group who historically has had inferior outcomes.

Timeline

Start
2014-12-08
Primary completion
2017-03-16
Completion
2017-03-16

Drugs

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