Leukemia Clinical Trial
Official title:
A Study of the Safety of CMA-676 in Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) in First Relapse
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating older patients who
have acute myeloid leukemia that has recurred for the first time following at least 3 months
of complete remission.
OBJECTIVES: I. Assess the efficacy of CMA-676 in elderly patients with acute myeloid
leukemia in first relapse in terms of the number of patients attaining a complete remission.
II. Assess the safety of CMA-676 in this patient population.
OUTLINE: This is an open label, single arm, multicenter study. Patients receive 1 course of
CMA-676 IV over 2 hours on day 1 followed by a 6 hour observation period. Patients may
receive 1 additional course of therapy 15 to 28 days later. There is a 28 day follow-up
period after the last dose of study medication. Patients are followed for an additional 6
months, then every 3 months for 18 months, and then every 6 months until relapse and/or
death.
PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 12
months. Enrollment will then be extended for up to an additional 55 patients.
;
Primary Purpose: Treatment
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