Venetoclax, Busulfan, Cladribine, and Fludarabine for the Treatment of High-Risk Acute Myeloid Leukemia or Myelodysplastic Syndrome

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. To obtain preliminary evidence of efficacy as defined by 1-year progression free survival. SECONDARY OBJECTIVES: I. To determine safety of this regimen as per National Cancer Institute (NCI) toxicity criteria. II. To determine time to neutrophil and platelet engraftment. III. T...

PRIMARY OBJECTIVE: I. To obtain preliminary evidence of efficacy as defined by 1-year progression free survival. SECONDARY OBJECTIVES: I. To determine safety of this regimen as per National Cancer Institute (NCI) toxicity criteria. II. To determine time to neutrophil and platelet engraftment. III. To determine incidence of acute and chronic graft versus host disease (GVHD). IV. To determine relapse incidence. V. To determine non-relapse mortality. VI. To determine overall survival. VII. To determine graft versus host disease-relapse free survival (GRFS). OUTLINE: Patients receive venetoclax orally (PO) once daily (QD) on days -22 to -3, busulfan intravenously (IV) over 3 hours on days -20, -13, -6, -5, -4, and -3, and fludarabine phosphate (fludarabine) IV over 1 hour and cladribine IV over 2 hours on days -6 to -3 in the absence of disease progression or unacceptable toxicity. Patients then undergo stem cell transplantation over 1-2 hours on day 0. After completion of study treatment, patients are followed up at 7 days, at engraftment, at 1, 3, 6, and 12 months, then annually for up to 3 years.

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