NCT00003961

Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Diseases

Interventions

Type	Name	Description
BIOLOGICAL	sargramostim

Timeline

• Start date: 1999-04-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2003-01-27
• Last updated: 2014-04-17

Locations

1 site across 1 country: United States