Pharmacokinetic Study of Busulfan in Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia
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|ClinicalTrials.gov Identifier: NCT01498016|
Recruitment Status : Unknown
Verified May 2016 by Jiong HU, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted : December 23, 2011
Last Update Posted : May 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute Leukemia||Drug: Busulfan||Phase 2|
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.
|Study Type :||Interventional|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetic Study of Intravenous Busulfan as Conditioning Regimen for Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||June 2017|
iv busulfan 1.6mg/kg given q12h
Iv busulfan 1.6mg/kg q12h D1- D4
Other Name: study group
- Area Under Curve (AUC) [ Time Frame: predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498016
|Contact: Jiong HU, M.D.||firstname.lastname@example.org|
|Blood & Marrow Transplantation Center, RuiJin Hospital||Recruiting|
|Shanghai, China, 200025|
|Contact: Jiong HU, M.D. 86-21-64370045 ext 601818 email@example.com|
|Principal Investigator:||Jiong HU, M.D.||Rui Jin Hospital, Shanghai JiaoTong University School of Medicine|