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Real-world Study of Darafenib or Trametinib and Clofarabine for High-risk/Recurrent/Refractory Langerhans Cell Histiocytosis in Children

RecruitingPhase 2Ages 0 Years - 18 YearsAllWest China Second University Hospital
NCT07022834 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Langerhans cell histiocytosis (LCH) is the most common histiocytosis in children, with an incidence of 2.6-8.9 per million. It is an inflammatory myeloid tumor with varied symptoms. Mild cases often resolve spontaneously, while severe cases can affect multiple organs and be life-threatening. LCH affecting the liver, spleen, or hematopoietic system has a poor prognosis and is high-risk group. The LCH-III study showed that low-risk children respond well to prednisone and vinblastine, with nearly 100% survival, but high-risk children's survival is about 80%, with a 30% reactivation rate.Long-term studies reveal that about 50% of patients are resistant to prednisone and vinblastine, leading to progression and recurrence. Except combination of prednisone and vinblastine, cladribine (introduced in 1998) and MAPK inhibitors (introduced in 2014), have lowered the mortality rate of LCH in childr

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Children aged 0-18 with LCH (CD1a+/CD207+); 2. Initial LCH diagnosis with hematopoietic, liver, or spleen involvement; 3. LCH patients with disease progression or reactivation after chemotherapy (e.g., prednisone, vincristine, cytarabine, clarithromycin) or targeted therapy; 4. Consent to treatment and follow-up; 5. ECOG score ≥ 2, Lansky score ≥ 50, organ function suitable for chemotherapy. Exclusion Criteria: 1. Other underlying diseases (e.g., primary immunodeficiency, heart/kidney failure, hepatitis, HIV, organ transplant); 2. Secondary tumor; 3. Recent chemotherapy, radiotherapy, or MAPK inhibitor use with lingering adverse effects; 4. Ongoing nephrotoxic drug use; 5. Refusal to consent. Exit Criteria: 1. Allergies to dabrafenib or trametinib and clofarabine； 2. Disease progression after 3 months on dabrafenib or trametinib； 3. Severe toxic side effects from clofarabine (grade 4 non-infectious non-hematological toxicity, SIRS, capillary leak syndrome)； 4）The doctor recommends halting the current treatment plan for the patient's benefit.
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What it tests

  • Dabrafenib or Trametinib and Clofarabine
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Where

1 site
Department of Pediatric Hematology and Oncology, West China Second University Hospital, Sichuan University, Chengdu, China
Chengdu, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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