NCT00004323

Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 0 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Evaluate the efficacy of related, HLA-identical bone marrow transplantation following cyclophosphamide (CTX) and antithymocyte globulin in patients with aplastic anemia. II. Evaluate the efficacy of related, HLA-nonidentical bone marrow transplantation following CTX and total-body irradiation/total-lymphoid irradiation in patients with aplastic anemia.

Detailed description

PROTOCOL OUTLINE: Patients with HLA-identical donors receive cyclophosphamide/mesna, antithymocyte globulin (ATG), and methylprednisolone (MePRDL), followed by allogeneic marrow transplantation. Patients with HLA-nonidentical (5/6 or 4/6) donors and those with a systemic reaction to ATG receive the same dosage of myeloablative chemotherapy and rescue. In addition, these patients are treated with total-body irradiation, total-lymphoid irradiation, and methotrexate. All patients received MePRDL and cyclosporine for graft-versus-host prophylaxis.

Conditions

• Aplastic Anemia

Interventions

Type	Name	Description
DRUG	anti-thymocyte globulin
DRUG	cyclophosphamide
DRUG	cyclosporine
DRUG	mesna
DRUG	methotrexate
DRUG	methylprednisolone

Timeline

• Start date: 1995-02-01
• First posted: 1999-10-19
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States