Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT07022834
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
18 Years
Study:
NCT07022834
Study Brief:
Protocol Section:
NCT07022834