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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 (NCT00003673)

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 older patients who have acute myeloid leukemia that has recurred for the first time following at least 3 months of complete remission.
  • Drug: chemotherapy
    • Drug: gemtuzumab ozogamicin
      Ages eligible for Study
      60 Years and older
      Genders eligible for Study
      Accepts Healthy Volunteers
      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 death.

      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.

      10 locations

      United States (10)
      • Arizona Cancer Center
        Not specified
        Tucson, Arizona, United States, 85724
      • Jonsson Comprehensive Cancer Center, UCLA
        Not specified
        Los Angeles, California, United States, 90095-1781
      • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
        Not specified
        Chicago, Illinois, United States, 60611
      • University of Chicago Cancer Research Center
        Not specified
        Chicago, Illinois, United States, 60637
      • New England Medical Center Hospital
        Not specified
        Boston, Massachusetts, United States, 02111
      • Barbara Ann Karmanos Cancer Institute
        Not specified
        Detroit, Michigan, United States, 48201
      • Long Island Jewish Medical Center
        Not specified
        New Hyde Park, New York, United States, 11040
      • New York Presbyterian Hospital - Cornell Campus
        Not specified
        New York, New York, United States, 10021
      • State University of New York Health Sciences Center - Stony Brook
        Not specified
        Stony Brook, New York, United States, 11790-9832
      • University of Pennsylvania Cancer Center
        Not specified
        Philadelphia, Pennsylvania, United States, 19104
      28 February, 1998
      20 August, 2012
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