A Study of the Efficacy and Safety of CMA-676 as Single Agent Treatment of Patients With Acute Myeloid Leukemia (AML) in First Relapse
18 Years
N/A
Both
Leukemia
Trial Information
A Study of the Efficacy and Safety of CMA-676 as Single Agent Treatment of Patients With Acute Myeloid Leukemia (AML) in First Relapse
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically diagnosed CD33 positive acute myeloid leukemia
(AML) in first relapse At least 6 months of complete remission No CNS leukemia No AML
secondary to exposure to chemotherapy or toxins
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC less than 30,000/mm3 at time of CMA-676 administration
Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL
Cardiovascular: No severe cardiac disease Pulmonary: No severe pulmonary disease Other:
Not pregnant or nursing Fertile patients must use an effective method of contraception Not
known to be HIV positive No prior myelodysplastic syndrome No other active malignancy No
uncontrolled infections Able to obtain bone marrow aspirate
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation No prior
anti-CD33 antibody therapy Chemotherapy: No prior chemotherapy for AML in first relapse
except hydroxyurea At least 24 hours since prior hydroxyurea Endocrine therapy: Not
specified Radiotherapy: Not specified Surgery: Not specified Other: At least 4 weeks since
prior investigational agents
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Mark Stanley Berger, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Wyeth is now a wholly owned subsidiary of Pfizer
Authority:
United States: Federal Government
Study ID:
W-AR-0903B1-201-US
NCT ID:
NCT00003131
Start Date:
February 1997
Completion Date:
February 2002
Related Keywords:
- Leukemia
- recurrent adult acute myeloid leukemia
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
| Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
| New England Medical Center Hospital | Boston, Massachusetts 02111 |
| New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
| Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
