Pharmacokinetic Study of Busulfan in Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacokinetic Study of Intravenous Busulfan as Conditioning Regimen for Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia|
- Area Under Curve (AUC) [ Time Frame: predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
iv busulfan 1.6mg/kg given q12h
Iv busulfan 1.6mg/kg q12h D1- D4
Other Name: study group
All patients received intravenous Busulfan based conditioning regimen for allogeneic stem cell transplantation.
Intravenous Busulfan (iv-Bu) was given 1.6mg/kg twice daily for 4 days as in the conditioning regimen.
Blood samples were obtained after first and 7th dose of iv Bulsulfan.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498016
|Contact: Jiong HU, M.D.||email@example.com|
|Blood & Marrow Transplantation Center, RuiJin Hospital||Recruiting|
|Shanghai, China, 200025|
|Contact: Jiong HU, M.D. 86-21-64370045 ext 601818 firstname.lastname@example.org|
|Principal Investigator:||Jiong HU, M.D.||Rui Jin Hospital, Shanghai JiaoTong University School of Medicine|