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Timing is everything: new trial aims to save lives from immune storm

NCT ID NCT07497438

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two strategies for starting the drug etoposide in adults with severe hemophagocytic lymphohistiocytosis (HLH) who are in the intensive care unit. HLH is a life-threatening overreaction of the immune system that can cause organ failure. The goal is to see if giving etoposide early, when organ failure first appears, reduces worsening organ damage compared to waiting to see if other treatments work first. About 176 participants will be randomly assigned to one of the two approaches.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 176 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patient * Confirmed diagnosis of HLH: * Hscore ≥ 169 * Diagnosis of HLH established by the multidisciplinary team caring for the patient(A 24/7 hotline will be available in case of diagnostic uncertainty: this will be the direct line to the on-call intensivist at Avicenne Hospital, who can contact the coordinating investigator as needed) * First episode of HLH * Admission to intensive care unit * Presence of one or more organ failures: * Circulatory: mBP \< 65 mmHg with lactate \> 2 mmol/L, or treatment with catecholamines * Respiratory: oxygen therapy \> 6 L/min or need for non-invasive ventilation, high-flow nasal cannula oxygen therapy, or invasive mechanical ventilation * Renal: stage 2 or higher according to KDIGO criteria, defined by a creatinine increase ≥ 2 times baseline, or urine output \< 0.5 mL/kg/h for ≥ 12 hours, or initiation of renal replacement therapy * Neurological: GCS ≤ 13 Exclusion Criteria: * Moribund patient with refractory distributive shock: multi-organ failure requiring noradrenaline \> 2.5 µg/kg/min and imminent risk of death. * Inability to administer etoposide within 12 hours. * Patient treated with etoposide prior to admission to the intensive care unit. * Hypersensitivity to etoposide or any of its excipients. * Hypersensitivity or contraindication to dexamethasone or any of its excipients, as described in the package insert for the dexamethasone specialty used in the trial and in the protocol. * Patient with a history of CAR-T cell therapy. * Patient developing HLH within 15 days following chemotherapy for cancer or hematologic malignancy. * Patient not covered by social security. * Patient under legal guardianship, tutelage, or curatorship. * Minor patient. * Pregnant women (positive βhCG), women for whom pregnancy has not been excluded (βhCG not performed in women of childbearing age), or lactating women. * Recent vaccination with a live attenuated vaccine. * Participation in another interventional research study.

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Conditions

The condition(s) this trial relates to.

cytokine release syndrome hemophagocytic syndrome Lymphohistiocytosis, Hemophagocytic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Intensive Care Unit - Avicenne Hospital, Assistance Publique des Hôpitaux de Paris

    Bobigny, 93000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.