NCT00004474

Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (planned)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 59 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Compare outcome, including graft failure, graft versus host disease, and survival of HLA-identical sibling bone marrow transplants for aplastic anemia using cyclophosphamide with or without antithymocyte globulin as a conditioning regimen.

Detailed description

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive cyclophosphamide IV over 60 minutes on days -5 to -2 with or without antithymocyte globulin IV over 4 hours. All patients then receive bone marrow over 60-120 minutes on day 0, 36 hours after the last dose of cyclophosphamide. Patients are followed at day 100, at 6 months, and at 1 year posttransplant.

Conditions

• Aplastic Anemia

Interventions

Type	Name	Description
DRUG	Anti-thymocyte globulin	Given via IV over 4 hours
DRUG	Cyclophosphamide	Given via IV over 60 minutes on Days -5 to -2
PROCEDURE	Bone marrow transplantation	Given on Day 0

Timeline

• Start date: 1998-09-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 1999-10-19
• Last updated: 2018-03-12

Locations

4 sites across 1 country: United States