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Biol Blood Marrow Transplant. Author manuscript; available in PMC 2014 Jun 11.
Published in final edited form as:
Biol Blood Marrow Transplant. 2013 Mar; 19(3): 474–480.
Published online 2012 Dec 7. doi:? 10.1016/j.bbmt.2012.12.001
PMCID: PMC4052712
NIHMSID: NIHMS580149
Dose intensification of Busulfan in the preparative regimen is associated with improved survival: A Phase I/II Controlled, Randomized Study
S Parmar,1 G Rondon,1 M deLima,1 P Thall,2 R Bassett,2 P Anderlini,1 P Kebriaei,1 I Khouri,1 P Ganesan,1 R Champlin,1 and S Giralt3
1Dept of Stem Cell Transplantation and Cellular Therapy, The University of Texas at MD Anderson Cancer Center, Houston, TX 77030
2Dept of Biostatistics, The University of Texas at MD Anderson Cancer Center, Houston, TX 77030
3Memorial Sloan Kettering Cancer Center, New York
Corresponding Author: Simrit Parmar, MD, Assistant Professor, MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, Email: gro.nosrednadm@ramraps
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Abstract
Dose intensity is important for disease control in patients undergoing allogeneic stem cell transplantation. We conducted a phase I/II controlled adoptive randomized study to determine the optimal dosing schedule of i.v. busulfan. Patients with advanced hematologic malignancies, ≤ 75 years with HLA-compatible donor were eligible. All patients received fludarabine at 30mg/m2/d for 4 days and busulfan was administered in different doses in oral or i.v. formulations. As determined by the phase I trial, i.v. busulfan at a dose of 11.2 mg/kg/d was utilized for the phase II expansion cohort. Altogether, 80 patients with a median age of 56 years were enrolled. Forty percent had active disease at the time of transplant. Engraftment occurred in 91% and a compl
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