Modified LCH-III chemotherapy with or without luvometinib for multisystem pediatric LCH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, multicenter interventional trial will assign children with newly diagnosed multisystem LCH to receive a modified LCH-III chemotherapy backbone with or without the MAPK pathway inhibitor luvometinib. Treatment includes prednisone, vincristine, and mercaptopurine with scheduled dosing per the modified regimen, and luvometinib is given concurrently in the experimental arm. Investigators will compare response, relapse rates, and safety between the two arms over defined follow-up periods. The rationale is that MAPK inhibition may sensitize LCH cells to chemotherapy and reduce relapse by altering the tumor immune environment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Children aged 0-18 years, of either sex.
2. Pathologically confirmed diagnosis of Langerhans cell histiocytosis (LCH) with positive staining for CD1a and/or CD207 (Langerin), and no prior treatment specifically directed against LCH.
3. Multisystem involvement of LCH, as determined by clinical and imaging evaluation.
4. Provision of written informed consent (by parent/legal guardian and, where appropriate, assent from the child), with willingness to comply with the study treatment regimen and follow-up assessments.

Exclusion Criteria:

1. Presence of any other significant underlying medical condition, including but not limited to primary immunodeficiency disorders, congestive heart failure, renal insufficiency, chronic viral hepatitis, HIV infection, or status post solid organ transplantation.
2. History of a second (secondary) malignancy.
3. QTcF interval \> 0.47 seconds on electrocardiogram performed prior to enrollment.
4. Ophthalmologic screening prior to enrollment revealing retinal vein occlusion, retinal pigment epithelial detachment, or other clinically significant ocular abnormalities that, in the opinion of the investigator, contraindicate participation.
5. LCH harboring Class 3 MEK pathway mutations, specifically the following alterations: L98\_I103del, L98\_K104del, P105\_A106del, P105\_I107delinsL, L101\_I103delinsF, E102\_I103delinsF, E102\_I103del, E102\_I103delinsV, E102\_I103delinsVN, E102\_K104delinsQ, or I103\_A106del.
6. Refusal or inability to provide written informed consent (or assent, as applicable).

Where it's running

• West China Second Hospital, Sichuan University
  Chengdu, China Recruiting
• Affiliated Hospital of Guizhou Medical University
  Guiyang, China Recruiting
• Anhui Provincial Children's Hospital
  Hefei, China Recruiting
• The Second Affiliated Hospital of Anhui Medical University
  Hefei, China Recruiting
• Jiangxi Provincial Children's Hospital
  Jiangxi, China Recruiting
• Kunming Children's Hospital
  Kunming, China Recruiting

Study contacts

• Study coordinator: Xue Tang
• Email: txily0912@126.com
• Phone: 86+18280145819

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dabrafenib and trametinib for rare cancers with BRAF V600 mutations

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  Recruiting at 15 sites Phase 2/3 Cancer Research UK · Belfast and 26 other locations · NCT07440290

• Dabrafenib or Trametinib plus Clofarabine for high-risk or relapsed pediatric Langerhans cell histiocytosis

  This treatment will test whether adding a MAPK inhibitor (dabrafenib or trametinib) to the chemotherapy drug clofarabine helps children and teens (0–18) with high-risk, recurrent, or refractory Langerhans cell histiocytosis.

  Recruiting Phase 2 West China Second University Hospital · Chengdu, Sichuan · NCT07022834

• Treatment with mirdametinib for histiocytic disorders

  This study is testing a new treatment called mirdametinib to see if it helps people with Langerhans cell histiocytosis and other histiocytic disorders feel better with fewer side effects than current options.

  Recruiting Phase 2 Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT06153173

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.