CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse
- Conditions
- Leukemia
- Registration Number
- NCT00003673
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States