Overview

Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT

Status:
Completed

Trial end date:
2007-11-01

Target enrollment:

Participant gender:

Summary

The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40% at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.

Phase:

Phase 2

Details

Lead Sponsor:

University of California, San Francisco

Treatments:

Busulfan
Fludarabine
Fludarabine phosphate
Methotrexate
Tacrolimus
Vidarabine