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Long-term hematopoiesis in transplantation survivors

Long-term integrity of hematopoiesis in pediatric stem cell transplantation survivors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20624
Enrollment
150
Registered
2021-07-01
Start date
2021-09-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Interventions

From each HSCT survivor, we will collect up to 50 mL peripheral blood. For participants <25 kg, the volume of blood will be adjusted to 2 mL per kg bodyweight (2.5% of total blood volume).

Sponsors

Prinses Máxima Center for Pediatric Oncology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Underwent allogeneic HSCT at age =18 yrs - A minimum survival of 5 years after HSCT. In case a patient has received multiple HSCTs, the last HSCT will be used to determine this 5-year minimum.

Exclusion criteria

Exclusion criteria: - Recipients of a “NiCord” HSCT. NiCord is a clinical trial on the safety and efficacy of transplantation of ex vivo expanded cord blood HSCs. As outcome measures of our study overlap with the outcome of this trial, NiCord recipients will be excluded. - Failure of the HSCT recipient and/or their legal representatives to understand the patient information and informed consent form (either due to intellectual disability or to language problems).

Design outcomes

Primary

MeasureTime frame
Determine the percentage of HSCT survivors with hematopoietic dysfunction, defined as: (1) cytopenia; (2) clonal hematopoiesis; (3) loss of donor chimerism; (4) bone marrow failure; (5) myelodysplasia; and (6) donor-cell leukemia.

Secondary

MeasureTime frame
Identify clinical determinants of hematopoietic dysfunction in long-term pediatric HSCT survivors compared to those without hematopoietic dysfunction. Analyze the integrity of hematopoiesis at a molecular level (pending funding).

Contacts

Public ContactKonradin Müskens

Princess Máxima Center

k.f.muskens-2@prinsesmaximacentrum.nl088 972 7272

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)