Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days -6,
-5, -4, and -3. Daily treatment doses will be adjusted to achieve target area under the
plasma concentration time curve (AUC). Day 0 is the day of hematopoietic progenitor cell
reinfusion. Supportive care will be based on institutional guidelines. Blood samples will be
collected for dose modification based on the AUC levels. Dose escalation will proceed to
determine the maximally tolerated level or AUC to evaluate the potential therapeutic benefit
of higher doses of busulfan.
Phase:
Phase 4
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute