Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Summary

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Description

PRIMARY OBJECTIVES: I. To assess response rate as determined by the International Working Group recommendations. SECONDARY OBJECTIVES: I. To assess safety and tolerability. II. To assess time on treatment. III. To assess overall survival. IV. To assess progression free survival. V. To assess long-te...

PRIMARY OBJECTIVES: I. To assess response rate as determined by the International Working Group recommendations. SECONDARY OBJECTIVES: I. To assess safety and tolerability. II. To assess time on treatment. III. To assess overall survival. IV. To assess progression free survival. V. To assess long-term response rate. EXPLORATORY OBJECTIVES: I. To explore biomarkers predictive of response or resistance to therapy including expression of CD38 at study entry and at relapse and response rate based on CD38 expression level. OUTLINE: Patients receive daratumumab intravenously (IV) over 3.25-6.5 hours on days 1, 8, 15 and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up monthly for 1 year, every 6 months for 1 year, and then annually thereafter.

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