Comparing the timing of etoposide and dexamethasone treatment for patients with severe sporadic hemophagocytic lymphohistiocytosis in intensive care.

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What is this study about?

This study focuses on patients with Hemophagocytic lymphohistiocytosis, a rare and serious condition where the immune system becomes overactive and causes excessive inflammation. This inflammation can lead to organ failure, which occurs when vital organs like the liver, kidneys, or lungs stop working correctly. The study is being conducted to compare two different ways of starting a treatment called etoposide in patients who are receiving intensive care. All patients in the study also receive dexamethasone, a medication used to reduce inflammation.

The first group will receive etoposide very early, within 12 hours of being admitted to the study. The second group will follow a delayed strategy, where the medication is only started if the patient’s condition does not improve after 48 hours. During the course of the study, researchers will monitor how these different timing strategies affect the development or worsening of organ problems. The study will also look at various aspects of recovery, such as the length of time spent in the hospital and the need for support from machines like a ventilator, which helps a person breathe.

Who Can Join the Study?

  • You must be an adult, meaning you have reached the age of legal maturity.
  • You must have a confirmed diagnosis of Hemophagocytic lymphohistiocytosis (HLH), which is a rare and serious condition where the immune system becomes overactive and attacks the body.
  • To confirm the diagnosis, you must meet at least 5 out of 6 specific medical signs, which include fever, an enlarged spleen (the organ that filters blood), cytopenias (a low count of different types of blood cells), high levels of triglycerides (fats in the blood) or low levels of fibrinogen (a protein that helps blood clot), evidence of hemophagocytosis (specialized immune cells eating other blood cells) in the bone marrow or organs, or very high levels of ferritin (a protein that stores iron).
  • The diagnosis must be officially confirmed by a multidisciplinary team, which is a group of different medical specialists working together.
  • This must be your first episode of this condition.
  • You must be admitted to the intensive care unit, a special hospital area for patients who need constant, close monitoring and advanced support.
  • You must be experiencing one or more types of organ failure, which means one of your body’s vital organs is not working correctly.
  • Circulatory failure requirements include very low blood pressure, high levels of lactate (a substance produced when the body’s tissues do not get enough oxygen), or the need for catecholamines (strong medicines used to raise blood pressure).
  • Respiratory failure requirements include needing significant oxygen therapy (extra oxygen supplied to the body), non-invasive ventilation (a mask that helps you breathe), high-flow nasal cannula oxygen therapy (a device that delivers high amounts of oxygen through the nose), or invasive mechanical ventilation (a breathing tube placed in the airway).
  • Renal failure requirements include kidney problems where creatinine (a waste product in the blood) is much higher than your normal level, or a very low urine output (the amount of urine your body produces) over 12 hours.
  • Neurological failure requirements include a Glasgow Coma Scale (GCS) score of 13 or less, which is a medical tool used to measure a person’s level of consciousness and awareness.

Who Cannot Join the Study?

  • Patients who are in a critical state of distributive shock, which is a condition where blood vessels lose their tone and blood pressure drops dangerously low, and who require very high doses of noradrenaline (a medicine used to raise blood pressure) and are at immediate risk of death.
  • People who have recently received a live attenuated vaccine, which is a type of vaccine that uses a weakened version of a germ.
  • Anyone with an allergy or medical reason not to use dexamethasone (a type of steroid medicine) or any of the other ingredients used to make it.
  • Patients who develop severe acute malnutrition (SAM), which is a serious state of extreme weight loss and lack of nutrients, within 15 days of receiving chemotherapy for cancer or blood diseases.
  • People who are already participating in another medical research study involving an intervention.
  • Situations where it is not possible to give the medicine etoposide (a type of chemotherapy drug) within 12 hours.
  • Patients who have already received etoposide before being admitted to the intensive care unit.
  • Anyone with an allergy to etoposide or any of the other ingredients used to make it.
  • Patients who do not have social security coverage.
  • Patients who are under legal guardianship, meaning someone else has been legally appointed to make decisions for them.
  • Minors, which refers to anyone under the legal age of adulthood.
  • Women who are pregnant or lactating (breastfeeding).

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

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Victor Dupouy Argenteuil France
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Hopital Beaujon Clichy France
Centre Hospital Region Metz Thionville Metz France
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Abqpnooiat Pbqgngec Hfnezszm Da Mznoljiuw Marseille France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
15.02.2026

Trial locations

Etoposide is a type of chemotherapy medicine that is given through a vein to help treat certain severe conditions by affecting how cells grow and multiply.

Dexamethasone is a type of steroid medicine that is used to reduce swelling and calm an overactive immune system.

Hemophagocytic lymphohistiocytosis – This condition occurs when the immune system becomes overactive and begins to attack the body’s own cells. It involves an excessive inflammatory response that can lead to widespread damage. As the condition progresses, the immune cells may begin to consume various blood cells within the organs. This process often results in the dysfunction of several major organ systems.

Trial ID:
2024-511807-41-01
Protocol code:
APHP230874
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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

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