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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

N_Krivoy, Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT01608204

First received: May 25, 2012

Last updated: May 29, 2012

Last verified: May 2012

History of Changes

Purpose

The correlation between Busulfan Pharmacokinetics in AML transplanted patients and their GST (A1,T1,M1 and P1), MDR-1 genetic profile. If a pre-genetic testing of those genes can be utilized as biomarkers of SOS and/or HGVHD. This study is not an interventional study it is only checking the GST gene and MDR-1 gene

Condition
Acute Myeloid Leukemia

Study Type:	Observational
Study Design:	Time Perspective: Prospective

Resource links provided by NLM:

Genetics Home Reference related topics: familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: Busulfan

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Biospecimen Retention: Samples With DNA

Peripheral Blood was used for DNA extraction

Enrollment:	63
Study Start Date:	January 2010
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Detailed Description:

BU levels are largely unpredictable, patients are often exposed to the toxic effects of inappropriate drug regimens before dose modifications can be made. Although the importance of TDM cannot be over emphasized, it entails trial and error and does not allow for pre- treatment dose optimization. This study, which provides an integration of genetic and pharmacokinetic data analysis of patients preconditioned for HSCT with high dose oral BU, aims to define biomarkers predictive of poor BU metabolism and clearance to prevent potential drug toxicity.This study is not an interventional study, only investigates the GST and MDR-1 genes in correlation with the "routine" Busulfan AUC done during the preparative regimen in HSCT for AML patients.

Eligibility

Ages Eligible for Study:	18 Years to 67 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adults suffering from AML who were selected to be treated by Hematological Stem Cell Transplantation

Criteria

Inclusion Criteria:

Acute Myeloid Leukemia who are clinically selected for HSCT according to known protocols.

Exclusion Criteria:

Unable to give informed consent

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	N_Krivoy, Director Clinical Pharmacology Unit, Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT01608204 History of Changes
Other Study ID Numbers:	BU/MEAdultPK/PGx1
Study First Received:	May 25, 2012
Last Updated:	May 29, 2012
Health Authority:	Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:

Pharmacokinetics
Busulfan
Polymorphism

GST
MDR-1(p-Glycoprotein)
Acute Myeloid Leukemia adult patients

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013

To Top