2025-524541-27-00招募中2 期
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 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2026年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 2
研究概览
简要总结
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.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
ANAKINRA
Test
干预措施: ANAKINRA (Drug)
研究者
Dr. C. Lindemans
Scientific
Prinses Maxima Centrum voor Kinderoncologie B.V.
研究点 (2)
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