NCT05362630Completed
Infliximab Efficacy, TDM and Serum TNFα Levels in Pediatric HSCT Recipients With aGVHD: Prospective Observational Study
Infliximab Efficacy in Relation to Therapeutic Drug Monitoring and Serum Tumor Necrosis Factor (TNF)α Levels in Pediatric HSCT Recipients With Acute Graft-versus-host Disease: a Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 5 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 28 (actual)
- First submitted
- 30 Apr 2022
- Start date
- 1 Apr 2022
- Primary completion date
- 28 Feb 2023
- Lead sponsor
- University of Pisa
- Diseases
- Childhood cancers
- NCT number
- NCT05362630
What you commit to
- Study type: Observational
- Participants enrolled: 28
- From 1 Apr 2022 to the primary completion date, 28 Feb 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active fungal or bacterial infection with life-threatening clinical condition (shock or respiratory distress that needs mechanical ventilation)
Other
- Follow up \< 6 months.
Who the study is looking for
- 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
Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Burlo Garofolo Coordinator of this site? Confirm its status | Trieste | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.