2025-524541-27-00RecruitingPhase 2
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
Prinses Maxima Centrum voor Kinderoncologie B.V.2 sites in 1 country76 target enrollmentStarted: May 1, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 76
- Locations
- 2
Study Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Age younger than eight months and/or weight < 10 kg.
- •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).
- •Participation in a clinical trial which prohibits participation in another clinical trial with an IMP.
- •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).
- •Patients for whom informed consent was not obtained.
- •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.
- •Known hypersensitivity to anakinra or to any of the other ingredients, or to proteins produced by Escherichia coli.
- •Previous treatment with TNF alfa blocking agents (within 5x half-life of the drug).
Arms & Interventions
ANAKINRA
Test
Intervention: ANAKINRA (Drug)
Investigators
Dr. C. Lindemans
Scientific
Prinses Maxima Centrum voor Kinderoncologie B.V.
Study Sites (2)
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