drugset / Trial / NCT00363467
Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 130 mg/m2 | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |