Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)
Completed · Phase 4
Conditions studied: Myelodysplastic Syndromes, Myeloproliferative Disorders, Leukemia, Lymphocytic, Myeloma, Lymphoma
In brief
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.
Key facts
- Study ID
- NCT00361140
- Run by
- H. Lee Moffitt Cancer Center and Research Institute
- People needed
- 72
- Starts
- 2005-08-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2017-03-03
Who can join
Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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