Langerhans cell histiocytosis
Conditions
Interventions
Traditional chemotherapy regimens group:Treated with Traditional chemotherapy regimens
Luvomeitinib group:Treated with Luvomeitinib
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age under 18 (inclusive). 2.Patients with newly diagnosed LCH confirmed by laboratory histology. 3.Patients must be able to provide sufficient tumor tissue specimens and peripheral blood for central laboratory testing of the following biomarkers: including but not limited to ERBB3, BRAF, ARAF, HRAS, KRAS, NRAS, MEK (MAP2K1 and MAP2K2), and other MEK upstream genes. If the patient is unable to provide tissue specimens, results from local laboratory testing of MAPK signaling pathway genes are acceptable. 4.Expected survival of at least 3 months. 5.Lansky (=16 years) performance status scores >=50. 6.The patient’s parent(s) and/or the patient consents to treatment under this protocol and signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received any of the following treatments: (1) Before starting the study drug treatment, patients who have received chemotherapy, targeted therapy, immunotherapy, biological therapy, or herbal anti-tumor treatment for LCH. (2) Within 4 weeks before starting the study drug treatment, patients who have received radiotherapy or major surgery (including craniotomy, thoracotomy, laparotomy, developmental bone or joint surgery, etc.). (3) Within 4 weeks before starting the study drug treatment, patients who have participated in other interventional clinical trials. (4) For patients with brain tumors (intracranial masses), those who used anticoagulants within 7 days before starting the study drug treatment. (5) Prednisone treatment at 470 ms; patients with risk factors for prolonged QTcF, such as uncorrectable hypokalemia, congenital long QT syndrome; or taking drugs that prolong QTcF (mainly class Ia, Ic, III antiarrhythmic drugs). Drugs that may prolong QTcF are listed in Appendix 3. (2) Congestive heart failure with NYHA classification >= 2; (3) Clinically significant arrhythmias, including but not limited to complete left bundle branch block or second-degree AV block; (4) Known clinically significant coronary heart disease, cardiomyopathy, or severe valvular disease. Echocardiography shows left ventricular ejection fraction (LVEF) < 50%. 8.Patients with active bacterial, fungal, or viral infections, including active hepatitis B (HBsAg-positive with HBV DNA greater than 1,000 IU/mL or meeting the study center’s diagnostic criteria for active hepatitis B infection) or hepatitis C (HCV RNA-positive), and human immunodeficiency virus (HIV) infection. 9.Known hypersensitivity to the study drug, other MEK1/2 inhibitors, or their excipients. 10.Patients known to have MAP2K1 exon 3 deletion (del) or deletion/insertion (delins/indels) mutations based on genetic testing of tumor tissue. 11.Conditions that researchers believe would interfere with participation in the study or prevent compliance with safety requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function, Quality of life scores;Time to Response;Safety ;Progression-free;The Disease Control Rate;Overall Survival (OS);Clinical benefit rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactYanlai Tang
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed