NCT01608204

Busulfan Pharmacokinetic Analysis and GST Pharmacogenetic Profile in Adults Undergoing Hematological Stem Cell Transplantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 18 Years – 67 Years
• Healthy volunteers: Not accepted

Summary

The correlation between Busulfan Pharmacokinetics in AML transplanted patients and their GST (A1,T1,M1 and P1), MDR-1 genetic profile. If a pre-genetic testing of those genes can be utilized as biomarkers of SOS and/or HGVHD. This study is not an interventional study it is only checking the GST gene and MDR-1 gene

Detailed description

BU levels are largely unpredictable, patients are often exposed to the toxic effects of inappropriate drug regimens before dose modifications can be made. Although the importance of TDM cannot be over emphasized, it entails trial and error and does not allow for pre- treatment dose optimization. This study, which provides an integration of genetic and pharmacokinetic data analysis of patients preconditioned for HSCT with high dose oral BU, aims to define biomarkers predictive of poor BU metabolism and clearance to prevent potential drug toxicity.This study is not an interventional study, only investigates the GST and MDR-1 genes in correlation with the "routine" Busulfan AUC done during the preparative regimen in HSCT for AML patients.

Conditions

• Acute Myeloid Leukemia

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2012-05-30
• Last updated: 2013-06-11