Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Clinical Trial
Official title:
A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission
This randomized phase II trial is studying how well cilengitide works in treating patients with acute myeloid leukemia. Cilengitide may stop the growth of cancer cells by blocking the enzymes necessary for their growth
PRIMARY OBJECTIVES:
I. Determine 10-month relapse-free survival of patients with acute myeloid leukemia in first
complete remission treated with cilengitide as maintenance therapy.
SECONDARY OBJECTIVES:
I. Determine overall survival of patients treated with this drug. II. Determine the safety
and toxicity of this drug in these patients. III. Determine the biological activity of this
drug in cells from these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.
Arm II: Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4
weeks.
In both arms, courses repeat every 4 weeks in the absence of disease relapse or unacceptable
toxicity.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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