2025-524541-27-00Not yet recruitingPhase 2
THRILL: Treat Hyperinflammation in child oncology study
THRILL: Treat Hyperinflammation in child oncology study - A single arm, historically controlled, open label phase II study on the efficacy and safety of the recombinant interleukin (IL)-1R antagonist anakinra in pediatric cancer patients admitted to the intensive care with sepsis and signs of hyperinflammation
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Sept 2026
Brief summary (registry, in English)
To assess the efficacy of early administration of the recombinant IL-1R antagonist anakinra as adjunctive treatment to standard of care (SoC) in pediatric cancer patients admitted to ICU with sepsis and signs of hyperinflammation on 28-day all-cause mortality compared to a historical cohort receiving standard of care only.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 11 Feb 2026
- Start date
- 1 May 2026
- Lead sponsor
- Prinses Maxima Centrum voor Kinderoncologie B.V.
- Diseases
- Childhood cancers
- EU CT number
- 2025-524541-27-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 76
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with cancer (or after a stem-cell transplant) who are in intensive care with a suspected or confirmed infection and signs of strong inflammation.
- Age
- From eight months to 18 years.
- Sex
- All sexes can join.
- Disease stage
- Admitted to intensive care with suspected or confirmed infection, a Phoenix Sepsis score of 2 or more, and serum ferritin of 2000 µg/L or more at admission. An underlying malignancy or a stem-cell transplant is required.
- Earlier treatment
- Cannot have had targeted anti-inflammatory treatment (biologic or JAK inhibitor) in the week before intensive care, anakinra in the month before, or TNF alfa blocking agents (within 5 times the drug's half-life).
- Biomarker or test result
- Serum ferritin of 2000 µg/L or more at intensive care admission.
Main reasons for not taking part
- Younger than eight months or weight under 10 kg
- Severe liver dysfunction as defined in the record
- Pregnant or breastfeeding, or not willing to use contraception
- Treatment limitations in place, such as a do-not-resuscitate order
- Known allergy to anakinra or to proteins from Escherichia coli
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant or lactating patients, or sexually active female patients of childbearing potential not willing to use a highly effective method of contraception for the duration of study therapy and pregnancy testing prior to inclusion.
- Sexually active, fertile male patients, not willing to use an effective method of contraception, for the duration of study therapy.
- Patients are excluded if predefined treatment limitations are in place at the time of ICU admission. Treatment limitations are defined as a do-not-resuscitate (DNR) order or any restriction on the use of mechanical ventilation, vasopressor or inotropic support, continuous renal replacement therapy, or extracorporeal membrane oxygenation (ECMO).
- Any prior underlying severe organ toxicity, for example CF patients with severe pulmonary dysfunction, patients with cardiac failure, patients with chronic renal failure, etc. either due to cancer, cancer treatment or prior causes.
- Treatment with targeted anti-inflammatory therapy for hyperinflammation (biologic or JAK inhibitor) in the week prior to ICU admission.
- Previous treatment with anakinra in the month prior to the ICU admission.
- Previous treatment with TNF alfa blocking agents (within 5x half-life of the drug).
Other illness
- Known hypersensitivity to anakinra or to any of the other ingredients, or to proteins produced by Escherichia coli.
Lab values
- Severe liver dysfunction according to the criteria of the European and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition including biochemical evidence of severe liver injury (no chronic impairment) and coagulopathy not corrected by vitamin K (prothrombin time (PT) ≥15 sec or international normalized ratio (INR) ≥ 1.5 with evidence of hepatic encephalopathy or PT ≥ 20 sec or INR > 2 with or without encephalopathy).
Age
- Age younger than eight months and/or weight < 10 kg.
Other
- Participation in a clinical trial which prohibits participation in another clinical trial with an IMP.
- Patients for whom informed consent was not obtained.
Who the study is looking for
- Children and adolescents with an age between eight months and 18 years admitted to ICU.
- An underlying malignancy (according to ICD-10 code) or post-HCT at time of ICU admission.
- Admitted to ICU with suspected or confirmed infection.
- Phoenix Sepsis score total ≥ 2
- Serum ferritin level ≥ 2000 µg/L at ICU admission, so called Phenotype 1 patients.
- Written informed consent/assent from patients and/or from parents or legal guardians for minor patients according to local law and regulations.
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | Not yet recruiting |
| Prinses Maxima Centrum voor Kinderoncologie B.V. | Utrecht | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.