NCT01071486

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

Busulfan Pharmacokinetic Analysis and Glutathione S-transferase (GST)Genetic Polymorphism (A1,T1,M1,P1)in Adults Undergoing Hematological Bone Marrow Transplantation (HSCT).

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Busulfan Pharmacokinetic Analysis
• GST Genetic Polymorphism

Interventions

Type	Name	Description
DRUG	Hematological Stem Cell Transplantation	Oral or Intravenous Busulfan as part of the preparative protocol for transplantation

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2010-02-19
• Last updated: 2015-11-10

Locations

1 site across 1 country: Israel