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

Rambam Health Care Campus

Status and phase: Withdrawn; Phase 4

Conditions: Busulfan Pharmacokinetic Analysis; GST Genetic Polymorphism

Treatments: Drug: Hematological Stem Cell Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01071486

BU-AdultPK/PGx1

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Malignant or Benign Diseases who need hematological stem cell transplantation as part of their treatment
• Busulfan should be part of the preparative protocol

Exclusion criteria

• Known sensitivity or allergy to Busulfan

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)