NCT00005893

Study of Allogeneic Bone Marrow Transplantation Using Matched, Related Donors in Patients With Nonmalignant Hematologic Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Fairview University Medical Center · Academic / Other
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Determine the efficacy of bone marrow transplantation using matched related donors in patients with nonmalignant hematologic disorders. II. Determine the quality of life, absence of adverse effects (e.g., graft versus host disease and B cell lymphoproliferative disease), and completeness of recovery of their underlying condition in these patients with this treatment regimen.

Detailed description

PROTOCOL OUTLINE: Patients receive IV or oral busulfan every 6 hours on days -9 to -6; cyclophosphamide IV on days -5 to -2; anti-thymocyte globulin IV on days -4 to -2; and allogeneic bone marrow transplantation (BMT) on day 0. Patients with class 3 thalassemia (liver edge greater than 2 cm below costal margin, a history of inconsistent chelation, and portal fibrosis) receive a less intensive conditioning regimen consisting of oral busulfan every 6 hours on days -7 to -4; anti-thymocyte globulin IV on days -5 to -1 and days 1-5; cyclophosphamide IV on days -3 to -2; and allogeneic BMT on day 0. Patients are followed at day 28, and then at 3, 6, 12, and 24 months.

Conditions

• Neutropenia
• Sickle Cell Anemia
• Thalassemia Major
• Red-Cell Aplasia, Pure

Interventions

Type	Name	Description
DRUG	anti-thymocyte globulin
DRUG	busulfan
DRUG	cyclophosphamide
PROCEDURE	Bone marrow transplantation

Timeline

• Start date: 2000-06-01
• First posted: 2000-06-05
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States