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A Prospective Registry of Pediatric Cellular Therapy Patients at Risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS).

ConditionHematopoietic Cell Transplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-26
SponsorDuke University

About this trial

This is a prospective international multi-center registry and biorepository trial of children and adolescents/young adults (AYA) undergoing hematopoietic cell transplantation (HCT) to assess the impact of endotheliopathies in the HCT setting as a contributor of significant morbidity and mortality.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children, adolescents and young adults (AYA) 0-26 years of age undergoing HSCT.

Recipients of autologous and allogeneic HSCT.

Any preparative regimen.

Disqualifiers

Any patient who does not consent/assent to participation.

Any patient for whom 5 mL blood sample(s) drawn at specified intervals would pose any more than minimal risk, as defined by institutional guidelines and at discretion of treating physician will be ineligible for biorepository banking.

Trial population

Children, adolescents and young adults (AYA) 0-26 years of age undergoing HSCT.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biorepository Trial

    Other intervention

    participating in this arm, peripheral blood specimen(s) will be obtained at 8 specified time-points.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Biorepository trial of children and adolescents/young adults (AYA)1 intervention

Trial outcomes

Primary outcomes

1

Proportion of pediatric patients undergoing hematopoietic cell transplant (HCT) who develop endotheliopathies (SOS, TMA, DAH and IPS) and/or MODS within 100 days of such therapies.

Time frame
through study completion, an average of 1 year
2

Proportion of pediatric patients undergoing (HCT) who experience abnormal levels of circulating angiogenic factors within 100 days post HCT-CT in the setting of endotheliopathies.

Time frame
through study completion, an average of 1 year
3

Proportion of pediatric patients undergoing (HCT) who experience abnormal levels of vascular permeability within 100 days post HCT-CT in the setting of endotheliopathies.

Time frame
through study completion, an average of 1 year
4

Proportion of pediatric patients undergoing (HCT) who experience abnormal levels of inflammatory factors within 100 days post HCT-CT in the setting of endotheliopathies.

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Overall survival.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov
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