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THRILL: Treat Hyperinflammation in child oncology study
EU CTIS ID: 2025-524541-27-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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).
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.