Expired Study
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Baltimore, Maryland 21231


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.

Study summary:

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.


DISEASE CHARACTERISTICS: - Cytologically proven myelodysplastic syndrome (MDS) of one of the following types: - Refractory anemia with excess blasts (RAEB) - RAEB in transformation - Chronic myelomonocytic leukemia - MDS with multiple chromosomal abnormalities - MDS with life threatening cytopenias in at least 2 cell lines - Platelet count < 30,000/mm^3 OR - Absolute neutrophil count no greater than 1,000/mm^3 OR - Anemia requiring transfusion support - Leukemia out of MDS (meet any of above requirements, but greater than 30% blasts in marrow) - No acute leukemia - Medically eligible for bone marrow transplant according to standard operating procedure of the Sidney Kimmel Cancer Center at Johns Hopkins Blood and Bone Marrow Transplant PATIENT CHARACTERISTICS: Age: - 18 to 65 Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Not specified Renal: - Not specified Other: - No prior acute allergic reactions to sargramostim (GM-CSF) - Not pregnant - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified



Primary Contact:

Principal Investigator
B. Douglas Smith, MD
Sidney Kimmel Comprehensive Cancer Center

Backup Contact:


Location Contact:

Baltimore, Maryland 21231
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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