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| Sponsor: | 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 |
| 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 | |
| Study Chair: | Richard K. Burt | Northwestern Memorial Hospital |
More Information
| Study ID Numbers: | 199/14983, NU-96AA1T, NU-96H |
| Study First Received: | June 6, 2001 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00017654 History of Changes |
| Health Authority: | Unspecified |
|
aplastic anemia disease-related problem/condition graft versus host disease hematologic disorders rare disease |
|
Anti-Inflammatory Agents Anti-Infective Agents Cyclosporine Immunologic Factors Molecular Mechanisms of Pharmacological Action Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Cyclophosphamide Hormones Neuroprotective Agents Cyclosporins |
Antifungal Agents Therapeutic Uses Anemia, Aplastic Dermatologic Agents Alkylating Agents Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Gastrointestinal Agents Anemia Methylprednisolone acetate Enzyme Inhibitors Glucocorticoids Protective Agents |