Status:
COMPLETED
Infliximab Efficacy, TDM and Serum TNFα Levels in Pediatric HSCT Recipients With aGVHD: Prospective Observational Study
Lead Sponsor:
University of Pisa
Conditions:
Graft Versus Host Disease, Acute
Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
Up to 18 years
Brief Summary
In children receiving a hematopoietic stem cell transplant (HSCT), blood levels of TNFalpha (an inflammatory cytokine) at the onset of the acute GVHD (graft-versus-host disease) could be correlated wi...
Detailed Description
Despite significant progress in overall survival and event-free survival in Pediatric Hematopoietic Stem Cell Transplant (HSCT), therapeutic options for graft-versus-host disease (GVHD) control remain...
Eligibility Criteria
Inclusion
- Allogeneic HSCT recipient;
- Onset of clinical signs of acute skin, gastrointestinal or hepatic GVHD according to the Glucksberg classification;
- At least five days of steroid treatment (minimum 1 mg/kg of methylprednisone or equivalent) for systemic aGVHD without clinical or laboratory signs of response or no steroid treatment for onset of grade I-II hepatic/gastroesophageal/intestinal isolated aGVHD;
- Patients who consent for the off-label use of infliximab and data processing for research purposes based on the institutional model GECO;
- At least one dose of infliximab received during aGVHD management;
- Minimum follow-up after infliximab administration: 6 months
Exclusion
- Follow up \< 6 months.
- Active fungal or bacterial infection with life-threatening clinical condition (shock or respiratory distress that needs mechanical ventilation)
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05362630
Start Date
April 1 2022
End Date
May 31 2025
Last Update
June 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IRCCS Burlo Garofolo
Trieste, Italy, 37137