drugset / Trial / NCT00363467

Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation

NCT00363467

NaSingle-groupOpen-labelOther

Summary

During the pre-transplantation phase (following completion of consolidation chemotherapy), patients will begin to receive G-CSF at 10 mcg/kg twice daily; leukapheresis will also be given until a target goal for recipient body weight is obtained, or up to a maximum of 5 days. Conditioning/Preparative therapy will follow PBSC collection for up to 30 days with Busulfan IV daily x 4 days; subsequent doses will be adjusted based on pharmacokinetic (plasma level)monitoring. Following 1 day of rest, stem cell reinfusion will begin with supportive care. During follow-up, patients will be monitored out to 730 days.

Timeline

Start
2006-05
Primary completion
2009-05
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 130 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 10 ug/kg Subcutaneous