A Phase II Trial Investigating Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia
Patients will be stratified at the time of enrollment based on diagnosis (ALL versus AML).
Based on this two-stage optimal design, a maximum of 49 patients with ALL and a maximum of
49 patients with AML will be needed. For each disease cohort, 21 patients will be enrolled
in stage 1. If at the end of stage 1, the criteria is met for activating stage 2 (based on
success of clearing MRD, proceeding to transplant within 42 days and without excessive
toxicity) for one or both groups, stage 2 will be activated with an additional 28 patients
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients Unable to Proceed to Transplantation
The primary endpoint of this study will be to determine the impact of Clofarabine, Cyclophosphamide and Etoposide on the conversion to an minimal residual disease (MRD) negative state at day 30 (<0.01% leukemic blasts by flow cytometry) or day 42 if day 30 marrow is un-evaluable due to hypocellularity per RECIST criteria as well as the ability of patients to reach allo-HCT without significant delay due to study treatment related toxicity. Unable to proceed to transplant by Day 42 will be considered unacceptable.
Between Day 30 and Day 42
Michael Burke, M.D.
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|