Busulfan Pharmacokinetic Analysis and GST Polymorphism in Adults Undergoing Hematological Stem Cell Transplantation
- Conditions
- Busulfan Pharmacokinetic AnalysisGST Genetic Polymorphism
- Registration Number
- NCT01071486
- Lead Sponsor
- Rambam Health Care Campus
- Brief Summary
Between 100 up to 200 adults undergoing HSCT for their primary disease will be included in this pharmacokinetic/pharmacogenetic study. In the preparative protocol Busulfan (BU)will be included as indicated in a known protocol. The GST polymorphism (A1,M1,T1 and P1) will be investigated using real time PCR. A correlation between pharmacokinetic parameters and patients polymorphism will be performed using known statistical technics for comparison. The aims of this study are, to correlate the demographic data, clinical presentation, clinical outcomes of the included individuals, the BU kinetics and the GST polymorphism and to establish an outcome "map" for those who receive HSCT for their primary disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Malignant or Benign Diseases who need hematological stem cell transplantation as part of their treatment
- Busulfan should be part of the preparative protocol
- Known sensitivity or allergy to Busulfan
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Hepatic Veno-Occlusive Disease, Graft versus host disease every week after HSCT up to 6 month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rambam Health Care Campus
🇮🇱Haifa, Israel