Hematopoietic Stem Cell Transplanation, Bone Marrow Transplant
Conditions
Interventions
DNA samples will be collected from all enrolled children by buccal swab, saliva at least 10 days prior to HSCT and will be sent for GSTA1 genotyping. The first dose of busulfan will be calculated acco
Sponsors
University Hospitals of Geneva
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: Patients must be aged from 0–18 years old on entry to the studyClinical indication of allogeneic or autologous hematopoietic stem cell transplantationThe conditioning protocol must include IV Bu formulationsThe expected length of time elapsing between recruitment and starting the conditioning regimen must be superior to 10 days Informed written consent to participate in the study has to be signed by the participant/parent/guardian.
Exclusion criteria
Exclusion criteria: Use of any drug with relevant drug-drug interaction with Bu during the days of administration of Bu up to 24h after the end of the last dose. Whenever those drugs can be stopped or replaced, a wash-out time is required prior to the first infusion of Bu. Confirmed pregnancy or refusal from the participant in guaranteeing an effective contraception during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of the first doses which result in AUCs within the therapeutic target range defined by the prescriber | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ability of the genotyping centers to deliver personalized first doses within the optimal delivery time (to be determined during the initial part of the trial). 2. retrospective incidence and severity of the following clinical outcomes during the first year after the transplantation: treatment-related toxicities (TRTs) including sinusoidal obstruction syndrome (SOS) and acute graft-versus-host disease (aGVHD) graft failure relapse or progression in patients with malignant diseases. overall survival (OS) and event-free survival (EFS) | — |
Countries
Australia, Canada, Denmark, France, Italy, Netherlands, New Zealand, Saudi Arabia, Switzerland, United Kingdom
Contacts
Public ContactR. Admiraal
Prinses Máxima Centrum voor Kinderoncologie
Outcome results
None listed