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Registry for Pediatric Cellular Therapy Patients at Risk for Complications

This study is a registry for children, adolescents, and young adults (ages 0-26) who are undergoing hematopoietic cell transplantation (HCT), also known as bone marrow transplant. The goal is to understand how certain complications, like endotheliopathies (problems with blood vessel lining such as sinusoidal obstruction syndrome, thrombotic microangiopathy, diffuse alveolar hemorrhage, and idiopathic pneumonia syndrome) and multi-organ dysfunction syndrome (MODS), affect patients after HCT. Researchers will collect blood samples at specific times to look for biomarkers and mechanisms like PD-1, BISPECIFIC, and CAR-T. The study aims to see how many patients develop these complications within 100 days of transplant and how abnormal levels of certain factors in the blood relate to these issues. You can join if you are undergoing HCT and are between 0 and 26 years old.

Study design
This is an observational study, meaning researchers will collect information without giving any specific treatments. It plans to enroll 500 participants.
What's involved
If you participate, peripheral blood samples will be taken at 8 specific time-points.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for an average of 1 year, with primary outcomes measured within 100 days of HCT.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05090345

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

Recruiting
Not specifiedAges 0–26Observational
Duke University
~500 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Biorepository Trial

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over through study completion, an average of 1 year
+3 more outcomes measured

Conditions

Hematopoietic Cell Transplantation

Explore related trials

Hematopoietic Cell Transplantation

Where it's being run

3 sites across 3 states
Minnesota1
North Carolina1
Texas1

Study leadership

  • Kris Mahadeo · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

LaTarsha Spencer
[email protected]
(919) 613-1895
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Children, adolescents and young adults (AYA) 0-26 years of age undergoing HSCT.
Recipients of autologous and allogeneic HSCT.
Any preparative regimen.

Exclusion

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.

What this trial measures

  • 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.through study completion, an average of 1 year
  • 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.through study completion, an average of 1 year
  • Proportion of pediatric patients undergoing (HCT) who experience abnormal levels of vascular permeability within 100 days post HCT-CT in the setting of endotheliopathies.through study completion, an average of 1 year
  • Proportion of pediatric patients undergoing (HCT) who experience abnormal levels of inflammatory factors within 100 days post HCT-CT in the setting of endotheliopathies.through study completion, an average of 1 year