A Prospective Registry of Pediatric Cellular Therapy Patients at Risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS).
NCT ID: NCT05090345
Last Updated: 2025-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2019-11-19
2026-02-05
Brief Summary
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Detailed Description
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* To evaluate the 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.
* To evaluate the proportion of pediatric patients undergoing hematopoietic cell transplant (HCT) who experience abnormal levels of circulating angiogenic, vascular permeability and inflammatory factors within 100 days post HCT-CT in the setting of endotheliopathies.
Secondary/Exploratory Objective(s):
* To determine the impact of endotheliopathies in the HCT setting on the overall survival.
* To assess the efficacy of specific prophylaxis and treatment strategies directed at endotheliopathies (SOS, TMA, DAH and IPS) post-HCT among enrolled children on overall survival.
* To assess whether exposure to immunotherapies (CAR-T, PD-1 Inhibitors, bispecific T-cell engager (BiTE) antibodies and antibody drug conjugates) prior to HCT affects post-HCT outcomes (endotheliopathies and MODS).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Biorepository Trial
participating in this arm, peripheral blood specimen(s) will be obtained at 8 specified time-points.
Interventions
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Biorepository Trial
participating in this arm, peripheral blood specimen(s) will be obtained at 8 specified time-points.
Eligibility Criteria
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Inclusion Criteria
* Recipients of autologous and allogeneic HSCT.
* Any preparative regimen.
Exclusion Criteria
* 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.
0 Years
26 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Kris Mahadeo
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Duke University
Durham, North Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Duke University Medical Center
Other Identifiers
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NCI-2021-11324
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00112697
Identifier Type: -
Identifier Source: org_study_id
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