Trial · NCT07431060
Modified LCH-III Regimen With or Without Luvometinib for Multisystem Pediatric Langerhans Cell Histiocytosis
NCT07431060, Not applicable, Recruiting, West China Second University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Modified LCH-III Regimen With or Without Luvometinib for Multisystem Pediatric Langerhans Cell Histiocytosis. Trials, record NCT07431060. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07431060
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Modified LCH-III Regimen With or Without Luvometinib for Multisystem Pediatric Langerhans Cell Histiocytosis
- NCT number
- NCT07431060
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 120 participants, estimated
- Lead sponsor
- West China Second University Hospital
- Conditions
- Langerhans Cell Histiocytosis (LCH)
- Interventions
- Prednisone, Vincristine, Mercaptopurine, Luvometinib
- First posted
- 2026-02-24
- Last updated
- 2026-02-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-Free survival rate | From Day 1 until the date of first event or last follow-up, assessed up to 2 years. | Event-free survival (EFS) is defined as the time from Day 1 to the first occurrence of any event, including disease reactivation , second primary malignancy, or death from any cause. Events will be assessed by clinical examination, imaging, and laboratory tests. The 2-year EFS rate will be estimated using the Kaplan-Meier method, reported as percentage with 95% confidence interval. |
| Secondary | Objective response rate | At 1 month and 3 months post-treatment | Objective response rate (ORR) is defined as the proportion of participants achieving NAD or ADB at the specified time points. Responses will be assessed by clinical evaluation, imaging, and risk organ function (if involved). ORR will be reported separately at 1 month and 3 months as percentage of participants with NAD or ADB (combined), with exact 95% confidence intervals. |
| Secondary | Overall survival rate | From Day1 until date of death from any cause or last follow-up, assessed up to 2 years. | Overall survival (OS) is defined as Day 1 to death from any cause. Participants alive at last follow-up will be censored. The 2-year OS rate will be estimated using the Kaplan-Meier method and reported as percentage with 95% confidence interval. |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | From Day 1 until through study completion, an average of 2 years | Safety and tolerability of the combination regimen (luvometinib added to modified LCH-III chemotherapy: prednisone + Vincristine backbone) will be assessed by the number of participants experiencing treatment-related adverse events (TRAEs), and serious adverse events (SAEs). Events will be graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Data will be summarized as: Incidence of any TRAE (percentage of participants) , Incidence by maximum grade (e.g., Grade 3-5) ,Incidence of specific events of interest (e.g., skin rash, hypertriglyceridemia, cytopenias) and Rate of treatment discontinuation due to toxicity |
Source ClinicalTrials.gov
Outcomes0
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.
Papers14
The papers the trial lists on ClinicalTrials.gov.
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/NCT07431060
GET https://conductscience.org/api/trials/v1/NCT07431060/registered