Clinical Trial: Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) After T-Lymphocyte Depleted Allogeneic BMT for Myelodysplastic Syndromes
Brief 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 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.
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sidney Kimmel Comprehensive Cancer Center
Dates:
Date Received: November 1, 1999
Date Started: April 1999
Date Completion:
Last Updated: April 16, 2014
Last Verified: April 2014
