NCT07204041进行中（未招募）2 期
Efficacy and Safety of XTD Regimen (Selinexor, Thalidomide and Dexamethasone) in Adult Patients With Relapsed/Refractory Langerhans Cell Histiocytosis: A Prospective, Multicenter, Single-Arm Study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
In adult patients with relapsed/refractory Langerhans cell histiocytosis (LCH), a treatment regimen of XTD regimen (Selinexor, Thalidomide and Dexamethasone) is planned to be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Organ pathology confirmed diagnosis of LCH;
- •Age 18 years or older;
- •Multi-system involvement, or single system with multiple lesions;
- •Disease not relieved after receiving at least one systemic treatment, or disease relapsed after improvement;
- •ECOG performance status score ≤2;
- •Clinical physician determines suitability for this treatment protocol;
- •Subjects can understand the study protocol and are willing to participate in this study, providing written informed consent.
排除标准
- •Single system single lesion LCH
- •Underwent major surgery within 4 weeks prior to the first administration of the study drug;
- •Underwent radiotherapy within 4 weeks prior to the first administration of the study drug;
- •History of myocardial infarction within the past year; suffers from New York Heart Association (NYHA) class 3 or 4 congestive heart failure, or has a history of NYHA class 3 or 4 congestive heart failure, unless left ventricular ejection fraction (LVEF) ≥ 50% in the echocardiogram (ECHO) screening performed within 1 month before entering the study;
- •Pregnant or breastfeeding women (women of childbearing age with positive pregnancy test at baseline or who have not undergone pregnancy testing. Postmenopausal women must have been menopausal for at least 12 months);
- •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, transaminase levels more than 10 times and bilirubin levels more than 3 times the upper limit of normal);
- •Severe hematological abnormalities: absolute neutrophil count less than 1 × 10^9/L, platelet less than 50×10^9/L;
- •Presence of uncontrolled infections;
- •Any other circumstances that the investigator believes to be inappropriate for the patient to participate in this trial;
研究组 & 干预措施
Adult patients with relapsed or refractory LCH
Experimental
(1) Relapsed or refractory LCH; (2) Age ≥ 18 years; (3) Multi-focal single system or multi-system involvement; (4) ECOG PS 0-2 score
干预措施: Selinexor (Drug)
Adult patients with relapsed or refractory LCH
Experimental
(1) Relapsed or refractory LCH; (2) Age ≥ 18 years; (3) Multi-focal single system or multi-system involvement; (4) ECOG PS 0-2 score
干预措施: Thalidomide (100mg) (Drug)
Adult patients with relapsed or refractory LCH
Experimental
(1) Relapsed or refractory LCH; (2) Age ≥ 18 years; (3) Multi-focal single system or multi-system involvement; (4) ECOG PS 0-2 score
干预措施: Dexamethasone (Drug)
结局指标
主要结局
PFS
时间窗: From enrollment to the end of treatment at 8 weeks
PFS defined as the time from XTD initiation to first documented disease progression, relapse after XTD, death from any cause, or last follow-up.
次要结局
- ORR(From enrollment to the end of treatment at 8 weeks)
- OS(From enrollment to the end of treatment at 8 weeks)
- Adverse Events(From enrollment to the end of treatment at 8 weeks)
研究者
研究点 (1)
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