Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in Adult Patients With Untreated LCH

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Langerhans Cell Histiocytosis

Treatments: Drug: Cytarabine (Ara-C); Drug: Thalidomide (100mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT07187193

NCCH006

Details and patient eligibility

About

Treatment of Adult Patients with Newly Diagnosed Langerhans Cell Histiocytosis (LCH) Using a Low-Dose Cytarabine Combined with Thalidomide Regimen.

Full description

AraC 100 mg/m² d1-5+ thalidomide 100mg d1-35, q35 days ,for a total of 12 cycles;followed by thalidomide 100mg, qd1-28 q28d,for a total of 12 cycles of monotherapy maintenance reatment;

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clearly diagnose and treat adult patients with multisystem or single-system multifocal LCH;
• Aged between 18 and 70 years;
• Multisystem involvement or single-system multifocal disease;
• No prior systemic treatment (patients who have only received local radiotherapy or surgery may be enrolled);
• ECOG performance status score ≤ 2;
• Judged by clinicians as suitable for treatment with this protocol;
• Patients or their families able to understand the study protocol and willing to participate in the study, providing written informed consent.

Exclusion criteria

• Patients with LCH involving the central nervous system;
• Single-system single-lesion LCH;
• Subjects who have undergone major surgery within 4 weeks prior to the first dose in the study;
• Subjects who have received radiotherapy within 4 weeks prior to the first dose in the study; subjects with a history of myocardial infarction within the past year;
• Patients with New York Heart Association (NYHA) class 3 or 4 congestive heart failure, or a history of NYHA class 3 or 4 congestive heart failure;
• Pregnant or lactating women;
• Abnormal liver and kidney function: creatinine level ≥176.8μmol/l (2mg/dl), transaminase and bilirubin levels more than 2 times the upper limit of normal (for LCH patients with liver involvement, bilirubin levels more than 10 times the upper limit of normal);
• Abnormal blood counts: absolute neutrophil count less than 1×10^9/L, platelet count less than 50×10^9/L;
• Patients or their families unable to understand the conditions and objectives of this study;
• Any other circumstances in which the investigator deems the patient unsuitable to participate in this trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Newly diagnosed LCH patients

Experimental group

Description:

(1) The histopathological diagnosis of LCH is confirmed; (2) Multi-system involvement or single-system with multiple lesions; (3) No prior systemic treatment (patients who have only received local radiotherapy or surgery are eligible);

Treatment:

Drug: Thalidomide (100mg)

Drug: Cytarabine (Ara-C)