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

Not Applicable

Completed

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

• Registration Number: NCT00005893
• Lead Sponsor: Fairview University Medical Center

Brief 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.

Study Timeline

• Study Start: 2000-06
• Study First Submitted: 2000-06-02
• Study First Submitted QC: 2000-06-02
• Study First Posted: 2000-06-05
• Status Verified: 2004-07
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Fairview University Medical Center; 🇺🇸 Minneapolis, Minnesota, United States