TIC-TAC-SAM « Comparison of two strategies of etoposide initiation in severe sporadic hemophagocytic lymphohistiocytosis in intensive care: a randomized trial »
interventional
N/A
1 country
27
Brief Summary
To compare the effect on the evolution of organ failures of two initiation strategies of etoposide in severe HLH in intensive care:
- An early strategy where etoposide is initiated within 12 hours after inclusion.
- A delayed strategy where this treatment is initiated only in case of unfavorable evolution after 48 hours
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- unknown
- Reported enrollment (type unavailable)
- Not reported
- Study completion date
Not reported
Date not reported- Listed locations
- 1 countries · 27 sites
Trial Relationships
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
October 25, 2024
Actual (reported)
Conditions
Outcome Measures
Primary Outcomes (1)
The occurrence of an event defined as the onset or worsening of organ failures, evaluated using the modified Sequential Organ Failure Assessment (SOFA) score (excluding the hematologic component). An event will be defined as an increase of at least 1 point for at least two organ systems compared to Day 0. In the delayed arm, the use of rescue etoposide treatment or in case of secondary aggravation during follow-up will also be considered an event.
Secondary Outcomes (14)
Time to death after inclusion (with a maximum follow-up duration of 60 days)
Number of ventilator-free days between inclusion and Day 14
Number of catecholamine-free days between inclusion and Day 14
Proportion of patients receiving at least one session of renal replacement therapy between inclusion and Day 14
Length of stay in the intensive care unit
- +9 more secondary outcomes
Interventions
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eligibility Criteria
You may qualify if:
- Adult patient
- Confirmed diagnosis of HLH: • Presence of 5 or more Henter criteria (HLH-04) out of the 6 achievable in routine care (fever, splenomegaly, cytopenias affecting 2 or 3 blood lineages, hypertriglyceridemia or hypofibrinogenemia, hemophagocytosis in bone marrow, spleen or lymph nodes, hyperferritinemia) • Diagnosis of HLH established by the multidisciplinary team caring for the patient
- 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 > 6L/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, either creatinine 2-2.9 times baseline, or urine output < 0.5 mL/kg/h for 12 hours • Neurological: GCS ≤ 13
You may not qualify if:
- 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
- Patient not covered by social security
- Patient under legal guardianship, tutelage, or curatorship
- Minor patient
- Pregnant or lactating woman
- Recent vaccination with a live attenuated vaccine
- Participation in another interventional research study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique Hopitaux De ParisType not reportedlead
Study Sites (27)
Assistance Publique Hopitaux De Paris
Paris Cedex 10, 75475, France
Centre Hospitalier De Versailles
Le Chesnay Rocquencourt, 78150, France
Assistance Publique Hopitaux De Paris
Paris Cedex 18, 75877, France
Assistance Publique Hopitaux De Paris
Garches, 92380, France
CHRU De Nancy
Vandoeuvre Les Nancy, 54500, France
Centre Hospitalier Sud Francilien
Corbeil Essonnes Cedex, 91106, France
Assistance Publique Hopitaux De Paris
Colombes, 92700, France
Assistance Publique Hopitaux De Paris
Paris, 75015, France
Assistance Publique Hopitaux De Paris
Paris, 75014, France
Assistance Publique Hopitaux De Paris
Creteil, 94000, France
Centre Hospitalier Universitaire De Montpellier
Montpellier Cedex 5, 34091, France
Assistance Publique Hopitaux De Paris
Clichy, 92110, France
Assistance Publique Hopitaux De Paris
Paris, 75012, France
Centre Hospitalier Victor Dupouy
Argenteuil Cedex, 95107, France
Centre Hospitalier Universitaire De Dijon
Dijon, 21000, France
Centre Hospitalier Universitaire D Orleans
Orleans Cedex 2, 45067, France
Centre Hospitalier Regional De Marseille
Marseille, 13015, France
Centre Hospitalier Universitaire de la Guadeloupe
Pointe A Pitre, 97139, France
Centre Hospitalier Universitaire Rouen
Rouen, 76000, France
Centre Hospitalier Universitaire Amiens Picardie
Amiens Cedex 1, 80054, France
Assistance Publique Hopitaux De Paris
Boulogne-Billancourt, 92100, France
Centre Hospitalier Universitaire De Lille
Lille Cedex, 59037, France
Centre Hospitalier Universitaire De Nice
Nice, 06200, France
Assistance Publique Hopitaux De Paris
Bobigny Cedex, 93009, France
Centre Hospital Region Metz Thionville
Metz Cedex 03, 57085, France
Assistance Publique Hopitaux De Paris
Paris, 75020, France
Assistance Publique Hopitaux De Paris
Le Kremlin-Bicetre, 94270, France
Central Study Contacts
Coordinating Investigator
Study Design
- Study Type
- interventional
- Phase
- phase 3
Study Record Dates
First Submitted
October 25, 2024
Source record
Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
- Registry identifier
- 2024-511807-41-00
- Data provider
- European Medicines Agency (EMA)
- Normalization version
- ctis-v1
Source retrieved:
Documents
- D1_Addendum Protocol N2_SAE Form_2024-511807-41-00
- D1_Addendum Protocol N3_Pregnancy Form_2024-511807-41-00
- D1_Protocol_2024-511807-41-00
- D1_Addendum Protocol N1_Liste investigateurs_2024-511807-41-00
- D1_Resume Protocole_2024-511807-41-00
- D1_Synopsis Protocol_2024-511807-41-00
- E2_SmPC Etoposide
- E2_SmPC Etopophos
- K1_Recruitment arrangements
- L1_SIS and ICF_adult patient pursuit
- L1_SIS and ICF_legal representative pursuit
- L1_SIS and ICF_adult patient
- L1_SIS and ICF_legal representative