Trial Information
Pharmacokinetic Study of Intravenous Busulfan as Conditioning Regimen for Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia
Inclusion Criteria:
- patient with acute myeloid or lymphoblastic leukemia in 1st or second remission
- age 18-55 years
- with inform consent
- no contraindication for allogeneic transplantation: active infection, allergy to
FLu/Bu/CTX, liver and renal function damage
- HLA matched related (6/6) or unrelated donors (at least 8/10)
Exclusion Criteria:
- age less than 18 years or over 56 years
- HLA mismatched related donor
- liver function/renal function damage (over 2 X upper normal range)
- with mental disease
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Area Under Curve (AUC)
Outcome Time Frame:
predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose
Safety Issue:
Yes
Principal Investigator
Jiong HU, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Authority:
China: Ethics Committee
Study ID:
RJH-Busulfan
NCT ID:
NCT01498016
Start Date:
November 2011
Completion Date:
June 2014
Related Keywords:
- Acute Leukemia
- acute leukemia
- allogeneic stem cell transplantation
- busulfan
- Leukemia
- Acute Disease