Acute Myeloid Leukemia Clinical Trial

CMA-676 in Treating Patients With Acute Myeloid Leukemia in First Relapse

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.

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Full 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.

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Eligibility 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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

55

Study ID:

NCT00003131

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 13 Locations for this study

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Arizona Cancer Center
Tucson Arizona, 85724, United States
Beckman Research Institute, City of Hope
Duarte California, 91010, United States
Sylvester Cancer Center, University of Miami
Miami Florida, 33136, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore Maryland, 21201, United States
New England Medical Center Hospital
Boston Massachusetts, 02111, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Long Island Jewish Medical Center
New Hyde Park New York, 11040, United States
New York Presbyterian Hospital - Cornell Campus
New York New York, 10021, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

55

Study ID:

NCT00003131

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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