Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia
Recruitment status was: Active, not recruiting
I. Determine the effect of supplementation with donor T-cell depleted, CD34+ peripheral blood stem cells on durable engraftment and incidence of graft-versus-host disease in patients with aplastic anemia undergoing allogeneic bone marrow transplantation.
|Graft Versus Host Disease Aplastic Anemia||Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: methylprednisolone Procedure: Allogeneic Bone Marrow Transplantation|
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||April 2001|
PROTOCOL OUTLINE: Bone marrow and peripheral blood stem cells (PBSC) are harvested from a HLA identical or 1 antigen mismatched related donor. PBSC are selected for CD34+ cells and T cells are depleted.
Patients receive cyclophosphamide IV over 2 hours on days -6 to -3 and anti-thymocyte globulin IV with methylprednisolone IV over 10-12 hours on days -5 to -3. T-cell depleted PBSC and bone marrow are infused on day 0. Patients receive cyclosporine IV over 12-24 hours on days -1 to 120 followed by a taper and methylprednisolone IV on days 7-64 for graft-versus-host disease prophylaxis.
Patients are followed every 30 days for 1 year, every 60 days for 2 years, and then as needed for a minimum of 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017654
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Study Chair:||Richard K. Burt||Northwestern Memorial Hospital|