Tracing stem cells after transplantatio

Conditions: <p>Allogeneic hematopoietic stem cell transplantation</p>

Registration Number: NL-OMON23273

Lead Sponsor: Princess Máxima Center for Pediatric Oncology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

(1) Allogeneic HSCT with bone marrow cells from a healthy sibling donor; (2) Age at HSCT <18 yrs; (3) First HSCT; (4) Availability of viably frozen donor bone marrow cells from the Biobank of the UMC Utrecht; (5) >95% donor chimerism; (6) No major HSCT-related complications (see 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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>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.</p>

Secondary Outcome Measures

Name	Time	Method
<p>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.</p>