Myelodysplastic Syndrome Clinical Trial
Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Baltimore Maryland, 21231, United States
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