Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)

PHASE4CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

February 29, 2012

Study Completion Date

February 29, 2012

Conditions
Myelodysplastic SyndromesMyeloproliferative DisordersLeukemia, LymphocyticMyelomaLymphoma
Interventions
DRUG

Busulfan

"Bu IV (BusulfexR) over 3 hours on days -6, -5, -4, and -3. Day -6 and -5 doses for patients on Level 1 will be 170mg/m2. This dose is based on the dose used by DeLima (2004) adjusted proportionately to achieve an AUC of 6000uM-min. Subsequent daily doses for patients on Level 1 will be adjusted to achieve an average AUC of 6000uM-min.~Day -6 and -5 doses for patients on Level 2 will be based on the mean dose required on Level 1 to achieve target AUC then adjusted proportionally for new target AUC.~Subsequent daily doses will be adjusted to achieve target AUCs."

DRUG

Fludarabine

Fludarabine 40mg/m2 IV over 1 hour on days -6, -5, -4, and -3

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

All Listed Sponsors
lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT00361140 - Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT) | Biotech Hunter | Biotech Hunter