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

Rambam Health Care Campus

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Busulfan Pharmacokinetic Analysis GST Genetic Polymorphism

Interventions

Hematological Stem Cell TransplantationDRUG

Oral or Intravenous Busulfan as part of the preparative protocol for transplantation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Rambam Health Care Campus

Haifa, Israel

Outcomes

Primary Outcomes

Hepatic Veno-Occlusive Disease, Graft versus host disease

Time frame: every week after HSCT up to 6 month

Data from ClinicalTrials.gov

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