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Precision Dosing of Busulfan in Children Undergoing HSCT — BuGenes01  

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:
Implementing Pharmacogenetics in the Busulfan Dosing Method for Children Undergoing Hematopoietic Stem-cell Transplantation: a Prospective, Multicentric, Randomized Clinical Trial

Clinical Trial Summary

The objective of this clinical trial is to evaluate the personalization the conditioning regimen prior to the hematopoietic stem cell transplant (HSCT) in children and adolescents, to improve HSCT efficacy while reducing conditioning-related toxicities. Namely, we are going to compare the accuracy of two methods for determining the first dose of busulfan, one of the medicines used during the conditioning regimen. First doses will be determined based either only on anthropometric information such as age and weight or by adding a genetic factor that influences the individual ability of busulfan metabolization.

Clinical Trial Description

Participants will be randomly assigned (1:1 ratio, stratified by conditioning regimen - the presence of fludarabine) to receive their first dose of busulfan according to: 1. the most performing method based on age and weight - McCune's model (control arm) 2. a method that also considers a pharmacogenetic factor (variants occurring in the promoter region of the GSTA1 gene) in association with the co-administered chemotherapeutic agent fludarabine in the dose personalization (experimental arm) This is an international study being carried out in five countries (Canada, Italy, Switzerland, France, and Denmark). ;

Study Design

Related Conditions & MeSH terms

  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Autologous Hematopoietic Stem Cell Transplantation
  • Hematopoietic Stem Cell Transplantation
Clinical Trial Details
NCT number NCT04822532
Study type Interventional
Source University Hospital, Geneva
Contact Marc Ansari, MD Prof
Phone +41795536100
Email research@cansearch.ch
Status Recruiting
Phase N/A
Start date June 15, 2021
Completion date June 2025
View Details
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