CMA-676 in Treating Patients With Acute Myeloid Leukemia in First Relapse
- Conditions
- Leukemia
- Registration Number
- NCT00003131
- 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 patients with acute myeloid leukemia in first relapse.
- Detailed Description
OBJECTIVES: I. Assess the efficacy of CMA-676 in terms of the number of patients with acute myeloid leukemia 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 CMA-676 IV over 2 hours on day 1. Patients may receive 1 additional dose of therapy 15 to 28 days later. Patients who achieve complete or morphologic remission are followed for an additional 6 months and every 3-6 months thereafter until relapse and/or death.
PROJECTED ACCRUAL: 55 evaluable patients will be accrued. 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 (13)
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States