PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients

Status:	Archived
Conditions:	Lymphoma
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	January 2010
End Date:	September 2012

A Multi-center, Phase 2, Single-Arm, Open-Label Exploratory Study of Individually- Optimized Conditioning Using Pharmacokinetics [PK]-Directed Dose Adjustment of Once Daily Intravenous Busulfan, Followed by Autologous Hematopoietic Stem Cell Transplant in Subjects With Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma

This is a study for the outcome and safety of individualized busulfan dosing with
cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat
Non-Hodgkin or Hodgkin's Lymphoma.

Evaluation of progression-free survival, transplant related mortality, overall survival, and
overall response rate, in subjects with NHL and HL receiving an IV busulfan-based
conditioning regimen with PK-guided IV busulfan dosing, followed by autologous HSCT as well
as comparison to those receiving carmustine, etoposide, cytarabine, and melphalan (BEAM)
conditioning regimen (and its variants) obtained from registry data in the Center for
International Blood and Marrow Transplant Research (CIBMTR) Assessment of the safety profile
of a BuCyE conditioning regimen with PK-directed dosing of IV busulfan will also be
completed.

We found this trial at

sites

Sarah Cannon Cancer Center

230 25th Ave N
Nashville, Tennessee 37203

(615) 329-7274