A Study of the Safety of CMA-676 in Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) in First Relapse
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.
Interventional
Primary Purpose: Treatment
Mark Stanley Berger, MD
Study Chair
Wyeth is now a wholly owned subsidiary of Pfizer
United States: Federal Government
W-AR-0903B1-203-US
NCT00003673
March 1998
March 1999
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |