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Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01071486

Enrollment

Registered

2010-02-19

Start date

2009-08-31

Completion date

2012-10-31

Last updated

2015-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Busulfan Pharmacokinetic Analysis, GST Genetic Polymorphism

Keywords

Busulfan, Glutathione S-transferase, Genetic polymorphism, HVOD, GVHD

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.

Interventions

DRUGHematological Stem Cell Transplantation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Hepatic Veno-Occlusive Disease, Graft versus host disease	every week after HSCT up to 6 month

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026