Registry of Pediatric Patients Undergoing Hematopoietic Cell Transplantation
Official title: Prospective Multi Center Study of Pediatric Cellular Therapy Patients at Risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS)
Run by Duke University · NCT05090345 · Data updated 2026-11-12
This study is trying to see how common certain health problems are in kids and teens after they have a stem cell transplant and how these issues relate to their recovery and survival.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 26 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 3 sites (Rochester, Minnesota and 2 other locations) |
| Status | Recruiting |
| Started | November 19, 2019 |
| Main results expected | February 5, 2027 |
| Study ends | February 5, 2028 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT05090345 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children, adolescents, and young adults aged 0-26 years who are undergoing hematopoietic stem cell transplantation.
✕Probably not a fit
Patients who do not consent to participate or for whom blood sample collection poses more than minimal risk will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective international multi-center registry and biorepository focused on children and adolescents undergoing hematopoietic cell transplantation (HCT). The study aims to evaluate the incidence of endotheliopathies and multi-organ dysfunction syndrome (MODS) within 100 days post-transplant. It will assess the levels of various circulating factors and their correlation with patient outcomes, including overall survival. Additionally, the study will explore the effects of prior immunotherapy on post-HCT complications.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for pediatric patients undergoing HCT, potentially reducing morbidity and mortality associated with endotheliopathies.
How similar studies have gone: While this approach is focused on a specific patient population and condition, similar studies have shown promise in understanding complications post-transplant, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children, adolescents and young adults (AYA) 0-26 years of age undergoing HSCT. * Recipients of autologous and allogeneic HSCT. * Any preparative regimen. Exclusion Criteria: * 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.
Where it's running
-
Mayo Clinic
Rochester, Minnesota, United States Recruiting -
Duke University
Durham, North Carolina, United States Recruiting -
MD Anderson Cancer Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Kris Mahadeo — Duke University
- Study coordinator: LaTarsha Spencer
- Email: latarsha.spencer@duke.edu
- Phone: (919) 613-1895
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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CD62L-depleted versus CD45RA-depleted donor lymphocyte infusions after haploidentical HSCT in children
This trial tests whether using CD62L-depleted donor lymphocytes after a haploidentical HSCT works better or worse than CD45RA-depleted lymphocytes in children.
-
CD19‑CAR T‑cell consolidation after TCRαβ/CD19‑depleted haploidentical family donor transplant for relapsed/refractory CD19+ B‑cell leukemia and lymphoma
This will try giving CD19‑targeted CAR T cells shortly after a partially matched family‑donor transplant to children and young adults (≤21) with relapsed or refractory CD19+ B‑cell leukemia or lymphoma to see if the approach is safe and feasible.
-
Using parametric response mapping to detect lung injury in transplant patients
This study is testing if a new imaging method can help predict lung problems in transplant patients who have chronic graft versus host disease or chronic lung disease.
-
Population PK-guided ATG Dosing in Haploidentical Stem Cell Transplant
This trial tests a population PK-guided ATG dosing strategy in people undergoing haploidentical hematopoietic stem cell transplantation to see if it improves outcomes.
-
Population PK-guided ATG Dosing in Haplo-HSCT
This study tests a population PK-guided dosing strategy for anti-thymocyte globulin (ATG) in adults and adolescents undergoing haploidentical stem cell transplantation to see if it can reduce GVHD while keeping relapse risk acceptable.
-
Low-dose liposomal amphotericin B to prevent invasive fungal infections in neutropenic children
This study tests whether giving a fixed low dose of liposomal amphotericin B can prevent invasive fungal infections in children aged 3–17 who are severely neutropenic after hematopoietic stem cell transplantation or similar high-risk conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.