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NCT05362630
Infliximab Efficacy, TDM and Serum TNFα Levels in Pediatric HSCT Recipients With aGVHD: Prospective Observational Study
trial in Graft Versus Host Disease, Acute in 28 participants. Completed in 31 May 2025.
28 February 2023
Quick facts
| Lead sponsor | University of Pisa |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 28 |
| Start date | 1 April 2022 |
| Primary completion | 28 February 2023 |
| Estimated completion | 31 May 2025 |
| Sites | 1 location across Italy |
Conditions studied
- Graft Versus Host Disease, Acute — all drugs for Graft Versus Host Disease, Acute →
- Hematopoietic Stem Cell Transplantation — all drugs for Hematopoietic Stem Cell Transplantation →
Sponsor
University of Pisa
Who can join
Under 18, any sex, with Graft Versus Host Disease, Acute or Hematopoietic Stem Cell Transplantation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 with the severity of the disease. The hypothesis is that the highest infliximab (a biologic drug against TNFalpha) could be associated with a significant reduction in TNFa levels and, subsequently, with a faster remission of the symptoms and prevention of disease progression. Moreover, a rapid drop of infliximab serum concentration, documented by therapeutic drug monitoring (TDM), could be related to the active phase of GVHD and higher production of TNFalpha. Therefore, the study is aimed at investigating whether the drop in infliximab plasma concentrations could be associated with clinical response and production of TNFalpha. HSCT children receiving infliximab to control GVHD are enrolled. Blood samples will be collected during treatment and they serve to measure drug and TNFalpha concentrations. Drug levels are analyzed by a population pharmacokinetic modeling and results are compared with plasma concentrations of TNFalfa and clinical response.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Advantage of First-Line Therapeutic Drug Monitoring-Driven Use of Infliximab for Treating Acute Intestinal and Liver GVHD in Children: A Prospective, Single-Center Study.
Maximova N, Nisticò D, Riccio G, Maestro A, et al · · 2023 · cited 3× · PMID 37509268 · DOI 10.3390/cancers15143605
Verify or expand the search:
- PubMed search for NCT05362630
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05362630 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Pisa
- Last refreshed: 5 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05362630.
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