NCT00017654

Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (planned)
• Sponsor: Northwestern Memorial Hospital · Academic / Other
• Sex: All
• Age: 15 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Graft Versus Host Disease
• Aplastic Anemia

Interventions

Type	Name	Description
DRUG	anti-thymocyte globulin
DRUG	cyclophosphamide
DRUG	cyclosporine
DRUG	methylprednisolone
PROCEDURE	Allogeneic Bone Marrow Transplantation

Timeline

• Start date: 2001-04-01
• First posted: 2001-06-06
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States