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Anakinra for Sepsis and Hyperinflammation in Pediatric Cancer Patients in the Intensive Care Unit

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying sepsis and hyperinflammation in children with cancer who are sick enough to need care in the intensive care unit. Sepsis is a serious body-wide reaction to infection, and hyperinflammation means the body’s defense system is overactive and may cause harm. The treatment being used is anakinra, given through a vein, together with standard hospital care. The purpose of the study is to see whether early treatment with anakinra can help children in this situation.

The study compares children who receive anakinra plus usual care with information from a past group of similar patients who received usual care only. The course of the study is simple: treatment is started early during the intensive care stay, and the children are then followed during the hospital stay and for about 28 days to see how they do. Safety is also checked, including possible side effects and signs of liver problems, new infections, and other serious health changes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of the trial treatment

    After you join the study, you receive anakinra as an added treatment to the usual care given for your illness.

    The medicine is given through a vein.

    The dose is 8 mg per kilogram of body weight.

    It is given once a day.

    The treatment is given during the study period, starting early after you are admitted to the intensive care unit with sepsis and signs of hyperinflammation.

  2. Step 2

    Monitoring during treatment

    While you are in the study, your condition is followed closely.

    The study checks for side effects, including their type, how often they happen, and how severe they are.

    Your liver tests are checked for serious changes in alanine aminotransferase (ALT) and bilirubin. ALT is a liver enzyme, and bilirubin is a substance in the blood that can rise when the liver is not working normally.

    The study also checks for new infections that happen after treatment begins.

    Your organ function is measured using the Phoenix-8 organ dysfunction score. This is a score that shows how well different organs are working.

  3. Step 3

    First three days after treatment begins

    During the first 3 days, the study compares the change in your Phoenix-8 organ dysfunction score with the score in a historical group that received standard care only.

    A historical group means patient data from an earlier time period is used for comparison.

  4. Step 4

    First seven days after treatment begins

    During the first 7 days, the study compares the change in your Phoenix-8 organ dysfunction score with the historical standard care group.

    The study also checks whether you need vasoactive medicines, which are medicines used to support blood pressure and blood flow.

    It records the highest VIS score and the total VIS score over 7 days. VIS means Vasoactive-Inotropic Score, a number that shows how much blood pressure support medicine is needed.

    The study checks whether you need CRRT or ECMO. CRRT means continuous kidney support treatment, and ECMO means a machine that supports the heart and lungs.

  5. Step 5

    Until day 28 after treatment begins

    The study follows your progress until day 28 after treatment begins.

    It checks whether you are alive at 28 days.

    It also records the number of days without a ventilator and the number of days without vasoactive medicines by day 28.

    The study compares your results with the historical standard care group.

    It records the length of time you stay in the intensive care unit, called ICU length of stay.

Who can join the trial?

7 criteria

  • Be a child or adolescent between 8 months and 18 years old.
  • Be admitted to the intensive care unit (ICU), which is the hospital area for very ill patients who need close monitoring.
  • Have an underlying malignancy, meaning a cancer diagnosis based on the medical coding system used by doctors, or have had a hematopoietic cell transplant (HCT) before or at the time of ICU admission. HCT is a transplant of blood-forming cells, often called a stem cell transplant.
  • Be admitted to the ICU with a suspected or confirmed infection, meaning doctors think an infection is present or have proven it with tests.
  • Have a Phoenix Sepsis score of at least 2. This is a medical score doctors use to measure how serious the infection-related illness is.
  • Have a serum ferritin level of at least 2000 µg/L at ICU admission. Ferritin is a blood test that can rise when there is strong inflammation in the body.
  • Have written informed consent from the patient and/or from a parent or legal guardian, depending on local laws and rules. Informed consent means agreeing to join the study after the study has been explained.

Who cannot join the trial?

13 criteria

  • Age younger than 8 months or body weight under 10 kg.
  • Severe liver dysfunction, meaning serious liver damage, including abnormal blood clotting tests that do not improve after vitamin K treatment. This includes PT of 15 seconds or more or INR of 1.5 or higher with signs of brain effects from liver failure, or PT of 20 seconds or more or INR above 2, with or without those brain effects.
  • Being in another clinical trial that does not allow participation in a second trial with an investigational medicine (a medicine being studied).
  • Being pregnant or breastfeeding.
  • Being a sexually active female who could become pregnant and is not willing to use a highly effective birth control method during the study and have pregnancy testing before joining.
  • Being a sexually active fertile male who is not willing to use an effective birth control method during the study.
  • Having a do-not-resuscitate (DNR) order, meaning no attempts to restart the heart if it stops, or any limit on using mechanical ventilation (a breathing machine), vasopressor or inotropic support (medicines that help blood pressure or heart pumping), continuous renal replacement therapy (continuous blood cleaning for kidney failure), or ECMO (a machine that supports the heart and lungs).
  • Not having informed consent, meaning permission to join the study was not properly given.
  • Having a previous serious problem with organ function, such as severe lung problems, heart failure, or chronic kidney failure, whether caused by cancer, cancer treatment, or another cause.
  • Having received a targeted anti-inflammatory treatment for hyperinflammation, such as a biologic medicine or a JAK inhibitor (a medicine that blocks certain immune signals), within the week before ICU admission.
  • Having received anakinra in the month before ICU admission.
  • Having a known allergy or hypersensitivity to anakinra, any of its other ingredients, or proteins made by Escherichia coli (a type of bacteria used to make some medicines).
  • Having received a TNF alpha blocking agent (a medicine that blocks a substance involved in inflammation) within the time period covered by 5 times that medicine’s half-life, meaning the time it takes for half of the drug to leave the body.
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Investigated drugs

Anakinra is the study medicine being tested in this trial. It is a man-made medicine that blocks a body signal called interleukin-1, which can help reduce harmful inflammation. In this study, it is given through a vein to children with cancer who are in the intensive care unit because of sepsis and signs of too much inflammation. It is being used together with standard hospital care to see if it can help improve survival and make the inflammatory response less severe.

What is already known about the treatment

Anakinra - Anakinra is given as an intravenous infusion, meaning it is delivered directly into a vein, usually in a hospital or intensive care setting. It is a well-known medicine in medical literature and is mainly used to calm harmful inflammation in the body; it has also been studied for sepsis and other severe inflammatory conditions. It is a biologic medicine called an interleukin-1 receptor antagonist, which means it blocks a signal protein called interleukin-1 so the immune system does not overreact and cause too much inflammation.

Investigated diseases

  • Sepsis

    Sepsis is a serious condition caused by the body's extreme response to an infection, which can spread through the bloodstream and affect many organs. It often begins with fever, fast breathing, fast heart rate, and weakness, and it can progress to confusion, low blood pressure, and organ dysfunction if the infection and inflammatory response continue. In some cases, the condition worsens quickly as inflammation becomes widespread and the body's normal functions begin to fail.

  • Hyperinflammation

    Hyperinflammation is an excessive and uncontrolled immune response in which the body releases too many inflammatory signals. It can develop during severe infection, cancer, or other illnesses and may cause persistent fever, swelling, and worsening organ function. The condition can progress from a strong immune reaction to widespread inflammation that affects several body systems.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2025-524541-27-00Protocol codeMB24THREstimated enrolment76 patientsSponsorPrincess Maxima Center For Pediatric Oncology

sourced from the EU Clinical Trials Register and site verification

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