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

Busulfan Pharmacokinetic Analysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01071486
• Other study ID #: BU-AdultPK/PGx1
• Status: Withdrawn
• Phase: Phase 4
• First received: February 18, 2010
• Last updated: November 8, 2015
• Start date: August 2009
• Est. completion date: October 2012

Study information

• Verified date: November 2015
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Busulfan Pharmacokinetic Analysis
• GST Genetic Polymorphism

Intervention

Drug:
• Hematological Stem Cell Transplantation
Oral or Intravenous Busulfan as part of the preparative protocol for transplantation

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Israel Cancer Association

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic Veno-Occlusive Disease, Graft versus host disease		every week after HSCT up to 6 month	Yes