Study on Ruxolitinib and Drug Combination for Critically Ill Adults with Acquired Hemophagocytic Syndrome

2 1 1 1

What is this study about?

This clinical trial is focused on studying a condition known as acquired hemophagocytic syndrome (HS), which is a serious disorder where the body’s immune system becomes overly active and starts attacking its own tissues. The study is investigating the use of a medication called ruxolitinib, which is a type of drug known as a JAK inhibitor. This medication is being tested to see if it can help improve the condition of patients with HS who are critically ill and admitted to the intensive care unit (ICU). The goal is to determine if ruxolitinib, when used alongside standard treatments, can better reverse organ failure compared to standard treatments alone.

In this study, patients will receive either ruxolitinib or a placebo, in addition to the usual care they would receive for HS. The treatment period for ruxolitinib is up to 28 days. Other medications involved in the study include lidocaine hydrochloride monohydrate, methylprednisolone acetate, etoposide, and betamethasone sodium phosphate, which are used for various supportive treatments. The study will monitor the patients’ health, focusing on improvements in organ function and overall survival, as well as any changes in symptoms related to HS.

The trial will assess the safety of ruxolitinib in these patients and track various health indicators, such as temperature, blood cell counts, and levels of certain proteins in the blood that indicate inflammation. The primary measure of success will be a significant improvement in the patients’ organ function scores after seven days of treatment. The study aims to provide valuable insights into the potential benefits of using ruxolitinib for treating critically ill patients with acquired hemophagocytic syndrome.

1 joining the study

Upon meeting the eligibility criteria, which include being an adult over 18 years old with acquired hemophagocytic syndrome (HS) and admitted to the intensive care unit (ICU), participation in the study begins.

Informed consent is required, either from the patient or a family member if the patient is unable to provide it.

2 treatment initiation

The treatment involves the administration of ruxolitinib in combination with standard care. Ruxolitinib is provided in the form of Jakavi 5 mg tablets and is taken orally.

The objective is to improve organ function as measured by the SOFA score, which assesses the extent of a patient’s organ function or rate of failure.

3 monitoring and assessment

The primary endpoint is survival with a decrease in the SOFA score by at least 3 points by day 7.

Secondary endpoints include overall survival, changes in temperature, SOFA score, and various biological markers related to HS, such as ferritin levels and white blood cell count.

Safety of ruxolitinib is also monitored throughout the study.

4 completion of the study

The study is estimated to conclude by October 16, 2025.

Upon completion, data regarding the effectiveness and safety of the treatment will be analyzed.

Who Can Join the Study?

  • Must be an adult older than 18 years.
  • Must have acquired hemophagocytic syndrome (HS), which is a condition diagnosed by specific criteria.
  • Must be admitted to the Intensive Care Unit (ICU).
  • Must need treatment for HS related to organ failure, as shown by a specific score called the SOFA score of 4 or higher. The SOFA score is a way to measure how well the organs in the body are working.
  • Must have informed consent signed by the patient or a family member/trustworthy person if the patient cannot sign due to their condition. In emergencies, consent can be obtained later when the patient is able.
  • If the patient is a woman who can have children, she must use a highly effective contraceptive method during the study and for one day after treatment ends.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
Institut Gustave Roussy Villejuif France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Toulouse Toulouse France
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Nantes Nantes France
Azqspfuour Pndvpsge Hgiejhnh Dq Pifrg Paris France
Admayavlxi Pjhilmtt Holmujji Dj Peoto Paris France
Ipnwpksu Pxazeitamlfolkk Cfxqec Cwcvak Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
16.10.2023

Trial locations

Ruxolitinib is a medication being studied for its potential to help patients with acquired hemophagocytic syndrome, especially those who are critically ill. It is being tested to see if it can improve organ function when used alongside the usual treatments. The goal is to see if it can help patients recover better than with standard treatments alone.

Hemophagocytic Syndrome – Hemophagocytic Syndrome (HS) is a severe systemic inflammatory condition characterized by excessive immune activation. It involves the overproduction of immune cells and cytokines, leading to widespread inflammation and tissue damage. The disease can cause symptoms such as prolonged fever, enlarged liver or spleen, and cytopenias, which are low blood cell counts. As the condition progresses, it can lead to organ dysfunction, including liver, kidney, and lung involvement. The progression of HS is often rapid, requiring close monitoring and management.

Trial ID:
2023-504513-77-00
Protocol code:
APHP220919
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A study of ruxolitinib as first treatment for children with haemophagocytic lymphohistiocytosis (HLH)

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France
  • Comparing the timing of etoposide and dexamethasone treatment for patients with severe sporadic hemophagocytic lymphohistiocytosis in intensive care.

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    France