18 Years
67 Years
Both
Acute Myeloid Leukemia
Trial Information
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.
Inclusion Criteria:
- Acute Myeloid Leukemia who are clinically selected for HSCT according to known
protocols.
Exclusion Criteria:
- Unable to give informed consent
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
If GST and ABCB1 genes modify busulfan pharmacokinetics in AML patients who will be transplanted
Outcome Description:
If individuals diagnosed with AML carrying the GSTP1 variant allele rs1695 (heterozygotes) are at risk of developing supra-therapeutic BU AUC due to lower BU clearance, and if combined polymorphisms in GSTM1 and ABCB1 (3435 or 2677) are associated with BU clearance rates and AUC.
Outcome Time Frame:
end of BMT transplantation
Safety Issue:
No
Authority:
Israel: Ministry of Health
Study ID:
BU/MEAdultPK/PGx1
NCT ID:
NCT01608204
Start Date:
January 2010
Completion Date:
December 2011
Related Keywords:
- Acute Myeloid Leukemia
- Pharmacokinetics
- Busulfan
- Polymorphism
- GST
- MDR-1(p-Glycoprotein)
- Acute Myeloid Leukemia adult patients
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|
