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| Sponsored by: |
Northwestern Memorial Hospital |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00017654 |
Purpose
OBJECTIVES:
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 | Intervention |
|
Graft Versus Host Disease Aplastic Anemia |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: methylprednisolone Procedure: Allogeneic Bone Marrow Transplantation |
| MedlinePlus related topics: | Anemia Bone Marrow Transplantation |
| Drug Information available for: | Cyclophosphamide Methylprednisolone Cyclosporin Cyclosporine |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Estimated Enrollment: | 3 |
| 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.
Eligibility
| Ages Eligible for Study: | 15 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Patient Characteristics--
Contacts and Locations| United States, Illinois | |||||
| Northwestern Memorial Hospital | |||||
| Chicago, Illinois, United States, 60611 | |||||
| Northwestern Memorial Hospital |
| Study Chair: | Richard K. Burt | Northwestern Memorial Hospital |
More Information
| Study ID Numbers: | 199/14983, NU-96AA1T, NU-96H |
| First Received: | June 6, 2001 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00017654 |
| Health Authority: | Unspecified |
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