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Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) After T-Lymphocyte Depleted Allogeneic BMT for Myelodysplastic Syndromes (NCT00003961)

National Cancer Institute (NCI)
RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. PURPOSE: Phase II trial to study the effectiveness of sargramostim after bone marrow transplantation in treating patients who have myelodysplastic syndrome.
  • Biological: sargramostim
    Ages eligible for Study
    18 Years to 65 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES:

    - Determine the effect of sargramostim (GM-CSF) on the progression-free 1-year survival of patients with myelodysplastic syndrome who have undergone T-cell-depleted CD34+ augmented allogeneic bone marrow transplantation.

    OUTLINE: All patients receive elutriated, CD34+ stem cell augmented donor bone marrow according to another protocol on day 0.

    Patients receive sargramostim (GM-CSF) subcutaneously on days 5-60.

    Patients are followed on days 120, 180, 360 and periodically thereafter.

    PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 3-4 years.

    1 locations

    United States (1)
    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      Baltimore, Maryland, United States, 21231
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 March, 1999
    Updated:
    15 April, 2014
    Participants:
    0
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