Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases

Interventions

sargramostimBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Data from ClinicalTrials.gov

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