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A Study of the Efficacy and Safety of CMA-676 as Single Agent Treatment of Patients With Acute Myeloid Leukemia (AML) in First Relapse

Phase 2
18 Years
Not Enrolling

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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:


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


United States: Federal Government

Study ID:




Start Date:

February 1997

Completion Date:

February 2002

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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