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A Study of the Safety of CMA-676 in Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) in First Relapse

Phase 2
60 Years
Not Enrolling

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Trial Information

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

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: CD33 positive acute myeloid leukemia in first relapse At least 3
months of complete remission No history of a secondary leukemia evolving from a known
prior myelodysplastic syndrome or resulting from exposure to chemotherapy or toxins No
active CNS leukemia

PATIENT CHARACTERISTICS: Age: 60 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 2.0 mg/dL Renal: Creatinine no greater than 3.0 mg/dL
Cardiovascular: No uncontrolled cardiac disease Pulmonary: No uncontrolled pulmonary
disease Other: No other active malignancy No uncontrolled, life-threatening infections
Able to obtain bone marrow aspirate HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow and peripheral blood stem
cells transplantation No prior anti-CD33 antibody therapy Chemotherapy: Prior cytotoxic
chemotherapy for AML allowed No prior chemotherapy for AML in first relapse except
hydroxyurea At least 24 hours since prior hydroxyurea Recovered from prior antineoplastic
therapy (except alopecia) No concurrent cytotoxic chemotherapy Endocrine therapy: No
concurrent immunosuppressive therapy Radiotherapy: Not specified Surgery: Not specified
Other: At least 4 weeks since prior investigational agents No other concurrent
antileukemic therapy

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:

March 1998

Completion Date:

March 1999

Related Keywords:

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



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