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New treatment option for Langerhans Cell Histiocytosis (LCH)
Official title Real-world Study of Darafenib or Trametinib and Clofarabine for High-risk/Recurrent/Refractory Langerhans Cell Histiocytosis in Children
ClinicalTrials.gov ID: NCT07022834
What this study is testing
What is Dabrafenib or Trametinib and Clofarabine?
Dabrafenib or Trametinib and Clofarabine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for langerhans cell histiocytosis (lch).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 18
You may be able to join if
- Children aged 0-18 with LCH (CD1a+/CD207+);
- Initial LCH diagnosis with hematopoietic, liver, or spleen involvement;
- LCH patients with disease progression or reactivation after chemotherapy (e.g., prednisone, vincristine, cytarabine, clarithromycin) or targeted...
- Consent to treatment and follow-up;
- ECOG score ≥ 2, Lansky score ≥ 50, organ function suitable for chemotherapy.
You likely can't join if
- Other underlying diseases (e.g., primary immunodeficiency, heart/kidney failure, hepatitis, HIV, organ transplant);
- Secondary tumor;
- Recent chemotherapy, radiotherapy, or MAPK inhibitor use with lingering adverse effects;
- Ongoing nephrotoxic drug use;
- Refusal to consent. Exit Criteria:
- Allergies to dabrafenib or trametinib and clofarabine；
See the full eligibility criteria
- Children aged 0-18 with LCH (CD1a+/CD207+);
- Initial LCH diagnosis with hematopoietic, liver, or spleen involvement;
- LCH patients with disease progression or reactivation after chemotherapy (e.g., prednisone, vincristine, cytarabine, clarithromycin) or targeted therapy;
- Consent to treatment and follow-up;
- ECOG score ≥ 2, Lansky score ≥ 50, organ function suitable for chemotherapy.
- Other underlying diseases (e.g., primary immunodeficiency, heart/kidney failure, hepatitis, HIV, organ transplant);
- Secondary tumor;
- Recent chemotherapy, radiotherapy, or MAPK inhibitor use with lingering adverse effects;
- Ongoing nephrotoxic drug use;
- Refusal to consent. Exit Criteria:
- Allergies to dabrafenib or trametinib and clofarabine；
- Disease progression after 3 months on dabrafenib or trametinib；
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.