Trials / Unknown
UnknownNCT04822532
Precision Dosing of Busulfan in Children Undergoing HSCT
Implementing Pharmacogenetics in the Busulfan Dosing Method for Children Undergoing Hematopoietic Stem-cell Transplantation: a Prospective, Multicentric, Randomized Clinical Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- Sponsor
- University Hospital, Geneva · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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).
Conditions
- Hematopoietic Stem Cell Transplantation
- Allogeneic Hematopoietic Stem Cell Transplantation
- Autologous Hematopoietic Stem Cell Transplantation
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | GSTA1 genotyping | Diplotype determination based on 4 single-nucleotide polymorphisms (SNPs) occurring in the promoter region of the GSTA1 gene |
Timeline
- Start date
- 2021-06-15
- Primary completion
- 2025-06-01
- Completion
- 2025-06-01
- First posted
- 2021-03-30
- Last updated
- 2021-08-02
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT04822532. Inclusion in this directory is not an endorsement.