Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia
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|ClinicalTrials.gov Identifier: NCT00017654|
Recruitment Status : Unknown
Verified October 2003 by Office of Rare Diseases (ORD).
Recruitment status was: Active, not recruiting
First Posted : June 6, 2001
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease Aplastic Anemia||Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: methylprednisolone Procedure: Allogeneic Bone Marrow Transplantation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||3 participants|
|Study Start Date :||April 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017654
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Study Chair:||Richard K. Burt||Northwestern Memorial Hospital|