Study on Etoposide for Patients with Severe Hemophagocytic Lymphohistiocytosis in Intensive Care

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What is this study about?

This clinical trial is focused on studying a condition called Hemophagocytic Lymphohistiocytosis (HLH), which is a severe 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 Etoposide, which is commonly used in cancer treatment, to see how it can help manage this condition when it becomes severe and requires intensive care.

The purpose of the study is to compare two different strategies for starting treatment with Etoposide in patients with severe HLH. One strategy involves starting the treatment early, within 12 hours of the patient being included in the study. The other strategy involves delaying the start of the treatment until 48 hours later, but only if the patient’s condition does not improve. This approach will help researchers understand which timing is more effective in managing the condition and preventing further organ damage.

Participants in the study will be monitored closely to see how their condition progresses with each treatment strategy. The study will look at various outcomes, such as the time it takes for symptoms to improve, the number of days patients spend on ventilators, and the overall length of their hospital stay. The study aims to provide valuable insights into the best way to use Etoposide for treating severe HLH in intensive care settings.

1 joining the study

Upon joining the study, the patient is confirmed to have a diagnosis of hemophagocytic lymphohistiocytosis (HLH) and is admitted to the intensive care unit.

The patient must meet specific criteria, including having one or more organ failures and a confirmed first episode of HLH.

2 randomization

The patient is randomly assigned to one of two treatment strategies for the initiation of etoposide, a medication used in the study.

3 early etoposide initiation

In the early strategy, etoposide is administered within 12 hours after inclusion in the study.

The medication is given through an intravenous (IV) injection or infusion.

4 delayed etoposide initiation

In the delayed strategy, etoposide is administered only if there is an unfavorable evolution after 48 hours.

The medication is given through an intravenous (IV) injection or infusion.

5 monitoring and assessment

The patient’s condition is monitored using the modified Sequential Organ Failure Assessment (SOFA) score to evaluate organ failures.

The occurrence of an event is defined as the onset or worsening of organ failures, with an increase of at least 1 point for at least two organ systems compared to Day 0.

6 follow-up and outcomes

The study tracks various outcomes, including time to death, number of ventilator-free days, and length of stay in the intensive care unit.

The cumulative dose of etoposide over the first 14 days is recorded, along with other health indicators such as normalization of fibrinogen, decrease in ferritin, and decrease in triglycerides.

Who Can Join the Study?

  • The patient must be an adult.
  • The patient must have a confirmed diagnosis of Hemophagocytic Lymphohistiocytosis (HLH). This means they must meet 5 or more of the following criteria:
    • Fever
    • Splenomegaly: This is when the spleen is larger than normal.
    • Cytopenias: This means low blood cell counts affecting 2 or 3 types of blood cells.
    • Hypertriglyceridemia or Hypofibrinogenemia: High levels of fats in the blood or low levels of a protein that helps blood clot.
    • Hemophagocytosis: This is when certain cells eat other blood cells, and it can be found in the bone marrow, spleen, or lymph nodes.
    • Hyperferritinemia: High levels of a protein that stores iron in the blood.
  • The diagnosis of HLH must be confirmed by the medical team taking care of the patient.
  • This must be the patient’s first episode of HLH.
  • The patient must be admitted to an intensive care unit (ICU), which is a special hospital department for very sick patients.
  • The patient must have one or more organ failures. This means:
    • Circulatory failure: Blood pressure is too low (mBP 2 mmol/L), or the patient needs medication called catecholamines to support blood pressure.
    • Respiratory failure: The patient needs more than 6 liters of oxygen per minute, or needs special breathing support like non-invasive ventilation, high-flow nasal cannula, or a machine to help them breathe.
    • Renal failure: The kidneys are not working well, shown by certain levels of creatinine in the blood or low urine output.
    • Neurological failure: The patient has a Glasgow Coma Scale (GCS) score of 13 or less, which means they have reduced consciousness.

Who Cannot Join the Study?

  • Patients who do not have Hemophagocytic lymphohistiocytosis (HLH) cannot participate. HLH is a condition where the body’s immune system becomes overly active and attacks its own tissues.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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
Cmkucs Hwgklovukfh Ucawadifcccpy Dy Dbnen Dijon France
Abgsjhusym Pwnnasmv Hlbdyiht Dn Mgtnawski Marseille France
Cavl Dl Ntsmb Vandoeuvre Les Nancy France

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
15.01.2025

Trial locations

Investigated drugs:

Etoposide is a medication used in this trial to treat severe hemophagocytic lymphohistiocytosis (HLH), a condition where the body’s immune system becomes overly active and attacks its own tissues. The trial is comparing two strategies for starting etoposide treatment in patients with this condition who are in intensive care. One strategy involves starting etoposide early, within 12 hours of inclusion in the trial, while the other strategy involves delaying the start of etoposide until 48 hours later if the patient’s condition does not improve.

Hemophagocytic lymphohistiocytosis (HLH) – This is a rare disease characterized by an overactive immune system, leading to excessive inflammation. It involves the body’s immune cells attacking its own tissues, causing damage to organs such as the liver, spleen, and bone marrow. Symptoms often include prolonged fever, enlarged liver or spleen, and low blood cell counts. As the disease progresses, it can lead to organ dysfunction due to the excessive immune response. HLH can be triggered by infections, autoimmune diseases, or genetic mutations. The condition requires careful monitoring to manage the immune system’s activity and prevent further organ damage.

Trial ID:
2024-511807-41-00
Protocol code:
APHP230874
Trial Phase:
Therapeutic confirmatory (Phase III)

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