Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome

Johns Hopkins Medicine

Status and phase: Completed; Phase 2

Conditions: Leukemia; Myelodysplastic/Myeloproliferative Diseases; Myelodysplastic Syndromes

Treatments: Biological: sargramostim

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003961

JHOC-J9852

P30CA006973 (U.S. NIH Grant/Contract)

CDR0000067160, J9852

JHOC-98071505

NCI-G99-1544

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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