Registry of Pediatric Patients Undergoing Hematopoietic Cell Transplantation
Prospective Multi Center Study of Pediatric Cellular Therapy Patients at Risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS)
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 0 Years to 26 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 3 sites (Rochester, Minnesota and 2 other locations) |
| Trial ID | NCT05090345 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children, adolescents, and young adults aged 0-26 years who are undergoing hematopoietic stem cell transplantation.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rochester, Minnesota and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.