Hematopoietic Stem Cell Transplantation Based on Pharmacokinetic and Pharmacodynamic Modeling
In this study the investigators plan to develop a method to determine optimal busulfan dose through pharmacokinetic study.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Determination of Optimal Busulfan Dose Using Pharmacokinetic Modeling in Hematopoietic Stem Cell Transplantation|
- To develop a method to determine optimal dose of busulfan through pharmacokinetic study in hematopoietic stem cell transplantation. [ Time Frame: For 4 days used Buslufan through pharmacokinetic study in hematopoietic stem cell transplantation ] [ Designated as safety issue: Yes ]
- To evaluate survival, toxicities, engraftment rate of patients received optimal dose of busulfan. [ Time Frame: 1, 3, 6 and 12 months after transplantation ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: Busulfan, Pharmacokinetic
To develop a method to determine optimal dose of busulfan through pharmacokinetic study in hematopoietic stem cell transplantation.
First dose: busulfan (120 mg/m2 ivs once daily) (if age<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study
Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study we plan to develop a method to determine optimal busulfan dose through pharmacokinetic study.
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Daehangno, Jongno-gu, Korea, Republic of, 101|
|Principal Investigator:||Hyoung Jin Kang, M.D., Ph.D||Seoul National University Hospital|