Evaluating infliximab's effectiveness in children with acute graft-versus-host disease after stem cell transplant
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
This study is trying to see if the medication infliximab can help children with acute graft-versus-host disease after a stem cell transplant by looking at how it affects their treatment and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 21 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | University of Pisa Academic / other |
| Drugs / interventions | infliximab |
| Locations | 1 site (Trieste) |
| Trial ID | NCT05362630 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between infliximab treatment and TNFalpha levels in pediatric patients who have undergone hematopoietic stem cell transplantation and are experiencing acute graft-versus-host disease (aGVHD). It aims to determine if higher levels of infliximab correlate with lower TNFalpha levels and improved clinical outcomes. Blood samples will be collected to monitor infliximab concentrations and TNFalpha levels during treatment, providing insights into the drug's efficacy and the disease's progression. The study addresses the challenges of managing steroid-refractory aGVHD in children, a condition with limited treatment options.
Who should consider this trial
Good fit: Ideal candidates include children who are allogeneic HSCT recipients with clinical signs of acute GVHD after inadequate response to steroid treatment.
Not a fit: Patients with active life-threatening infections or those unable to complete a minimum follow-up of six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for pediatric patients suffering from acute graft-versus-host disease.
How similar studies have performed: While there have been mixed results in previous studies on GVHD treatments, the use of infliximab in this context is promising but not extensively tested in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Follow up \< 6 months. * Active fungal or bacterial infection with life-threatening clinical condition (shock or respiratory distress that needs mechanical ventilation)
Where this trial is running
Trieste
- IRCCS Burlo Garofolo — Trieste, Italy (Recruiting)
Study contacts
- Study coordinator: Natalia Maximova, MD
- Email: natalia.maximova@burlo.trieste.it
- Phone: +39 040 3785276
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.