AuthorisedTherapeutic exploratory (Phase II)Interventional

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

This research, called THRILL, is looking into a medicine called anakinra for children with cancer admitted to intensive care. These children are battling a severe type of infection called sepsis and their bodies are overreacting with dangerous inflammation, known as hyperinflammation. The study wants to find out if giving anakinra alongside standard care can improve their chances of survival within 28 days, compared to what we've seen in similar children in the past who only received standard care. Researchers will also be checking for any side effects and how anakinra affects how well different body organs are working.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Prinses Maxima Centrum voor Kinderoncologie B.V.

Enrolment target

Start

18 May 2026

Hyperinflammation, Sepsis

What is this study about?

When children with cancer become seriously ill in intensive care, they can sometimes develop a life-threatening response called sepsis. This is when their body overreacts to an infection, leading to widespread inflammation called hyperinflammation. This overreaction can damage their organs and make them even sicker. This study aims to find out if a medicine called anakinra can help these children.

Anakinra works by blocking certain signals in the body that cause inflammation. The researchers want to see if giving this medicine early, alongside the usual treatments, can calm down the body's overreaction and ultimately help more children recover. They will compare the health of children who receive anakinra to information gathered from similar children in the past who received only standard care.

This research is important because it could lead to better ways of treating very sick children with cancer, helping to reduce the serious complications of sepsis and hyperinflammation. By carefully studying anakinra, doctors hope to improve the chances of survival and recovery for these vulnerable patients.

Key takeaways

This study investigates if the drug anakinra can help seriously ill children with cancer who have sepsis and dangerous inflammation.
The goal is to improve survival rates compared to standard care alone.
Anakinra works by calming the body's overactive inflammatory response.
Children will receive anakinra alongside their usual intensive care treatments.
Researchers will monitor for improved health and any side effects for 28 days.

Who may be eligible?

This study is for children with cancer who are currently in intensive care. They must have developed a severe infection (sepsis) and show signs that their body is having a strong, harmful inflammatory reaction (hyperinflammation).

If your child fits this description, their medical team might consider if this study is suitable for them. The study is open to all ages and genders within the paediatric intensive care setting.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child currently in intensive care?
Does your child have a cancer diagnosis?
Does your child have a severe infection (sepsis)?
Does your child show signs of a strong, harmful inflammatory reaction (hyperinflammation)?

Answer every question to see your result.

What does participation involve?

If your child is eligible and you agree for them to take part, they will receive the study medicine, anakinra, in addition to their usual care. Doctors will closely monitor your child's health, including taking blood tests and observing their general condition, to see how the treatment is working and check for any side effects.

Researchers will also collect information about how long your child needs support for breathing difficulties or other organ problems while in intensive care. All of this monitoring is part of the standard care for very ill children, but additional data will be collected specifically for the study. The main focus will be on your child's health for the first 28 days after starting treatment.

Potential risks and benefits

The potential benefit of joining this study is that anakinra might help calm your child’s body’s dangerous inflammatory response, potentially improving their recovery and survival. However, like all medicines, anakinra can have side effects, which doctors will monitor closely. There is also the possibility that it may not help. You are free to withdraw your child from the study at any time without affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is 'sepsis'?

Sepsis is a life-threatening reaction by the body to an infection. It can cause organs to be damaged.

What does 'hyperinflammation' mean?

Hyperinflammation is when the body's immune system overreacts with too much inflammation, which can be harmful, during a severe infection like sepsis.

What is anakinra?

Anakinra is a medicine that helps to block certain signals in the body that cause inflammation, aiming to reduce the harmful overreaction seen in severe sepsis and hyperinflammation.

Will my child receive only anakinra if they join?

No, your child will receive anakinra in addition to all the standard treatments and care they would normally get in intensive care for their condition.

How long will my child be in the study?

The main focus of the study's monitoring is for the first 28 days after your child starts the treatment.