Allogeneic hematopoietic stem cell transplantation
Conditions
Interventions
None listed
Sponsors
Princess Máxima Center for Pediatric Oncology
Eligibility
Inclusion criteria
Inclusion criteria: (1) Allogeneic HSCT with bone marrow cells from a healthy sibling donor; (2) Age at HSCT 95% donor chimerism; (6) No major HSCT-related complications (see exclusion criteria).
Exclusion criteria
Exclusion criteria: (1) Major HSCT-related complications, such as >grade 2 graft versus host disease; (2) Secondary graft failure; (3) Objection to be notified about actionable findings from whole-genome sequencing; (4) Failure of the HSCT recipient, donor and/or their legal representatives to understand the patient information and informed consent form (either due to intellectual disability or to language problems). Of note: Only include subjects in whom both the HSCT recipient and his/her donor (and, if applicable, their caregivers) agree to participate in the current study are eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study endpoints are: (1) The total number of somatic mutations acquired after HSCT in the HSCT recipient and his/her donor; (2) The frequency of HSC clones contributing to production of each of the mature blood lineages in the HSCT recipient and donor. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: (3) Identification of potential causes of HSC mutagenesis upon HSCT; (4) Generation of an experimental method to retrospectively assess the impact of common clinical parameters (donor age, conditioning regimen, etc) on HSC integrity. | — |
Contacts
Public ContactMirjam Belderbos
Princess Máxima Center for Pediatric Oncology
Outcome results
None listed