Trial · NCT07497438
Comparison of Two Etoposide Initiation Strategies for Severe Hemophagocytic Lymphohistiocytosis
NCT07497438, Phase 3, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Two Etoposide Initiation Strategies for Severe Hemophagocytic Lymphohistiocytosis. Trials, record NCT07497438. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07497438
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Two Etoposide Initiation Strategies for Severe Hemophagocytic Lymphohistiocytosis
- NCT number
- NCT07497438
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 176 participants, estimated
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Hemophagocytic Lymphohistiocytosis
- Interventions
- Etoposide (Early strategy), Etoposide (Delayed strategy)
- First posted
- 2026-03-27
- Last updated
- 2026-04-23
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Increase of at least 1 point in the modified SOFA score (excluding the hematologic component) 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 | every 12 hours from Day 1 to Day 5 (Day 0 = inclusion), and then every 24 hours from Day 6 to Day 14 | 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, from 0 to 20 points), calculated every 12 hours from Day 1 to Day 5 (Day 0 = inclusion), and then every 24 hours from Day 6 to Day 14. 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 | Survival | 60 days | Time to death after inclusion (with a maximum follow-up duration of 60 days) |
| Secondary | Duration of mechanical ventilation | 14 days after inclusion | Number of ventilator-free days between inclusion and Day 14. A live discharge from the intensive care unit will be considered equivalent to no mechanical ventilation (event) from the date of discharge. Patients who died before day 14 will be assigned a value of 0 days, corresponding to no days alive without ventilation. |
| Secondary | Duration of catecholamine therapy | 14 days after inclusion | Number of catecholamine-free days between inclusion and Day 14. A live discharge from the intensive care unit will be considered equivalent to an absence of catecholamines (event) from the date of discharge. Patients who died before D14 will be assigned a value of 0 days, corresponding to an absence of live days without catecholamines. |
| Secondary | Need for renal replacement therapy. | 14 days after inclusion | Proportion of patients receiving at least one session of renal replacement therapy between inclusion and Day 14. Discharge from intensive care without prior extrarenal purification will be considered a non-event. Death without prior extrarenal purification will be considered a non-event. |
| Secondary | Length of stay in the intensive care unit | 60 days | Length of stay in the intensive care unit |
| Secondary | Length of hospital stay | 60 days | Length of hospital stay |
| Secondary | Proportion of patients receiving etoposide treatment | 60 days | Proportion of patients receiving a dose of etoposide |
| Secondary | Cumulative dose of etoposide | 14 days after inclusion | Cumulative dose of etoposide over the first 14 days, within the total study population and among those receiving at least one dose of treatment |
| Secondary | Time to initiation of etoposide treatment | 60 days | Number of days between inclusion and initiation of etoposide treatment in patients who received etoposide. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07497438
GET https://conductscience.org/api/trials/v1/NCT07497438/registered