NCT07187167招募中2 期
Efficacy and Safety of the RD Regimen (Lenalidomide, Dexamethasone) in the Treatment of Rosai-Dorfman Disease: 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4月12日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progression-free survival time （PFS)
研究概览
简要总结
In patients with Rosai-Dorfman disease (RDD), a treatment regimen of lenalidomide combined with dexamethasone is planned to be used.
详细描述
Patients received oral lenalidomide 25mg on days 1-21 and dexamethasone 40mg on days 1, 8, 15, 22, in 28-day cycles for 12 total cycles.
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
- •Definitively diagnosed adult RDD patients;
- •Aged between 18 and 80 years;
- •Treatment-naive or refractory/relapsed;
- •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.
排除标准
- •Subjects who have undergone major surgery within 4 weeks prior to the first dose of the study;
- •Subjects who have received radiotherapy within 4 weeks prior to the first dose of 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;
- •Patients who cannot strictly practice contraception after participating in the study;
- •Abnormal liver and kidney function: creatinine level ≥176.8 μmol/L (2 mg/dL), transaminase and bilirubin levels more than 2 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 who cannot understand the conditions and objectives of the study;
- •Any other situation where the investigator considers the patient unsuitable to participate in this trial.
研究组 & 干预措施
Patients with RDD
Experimental
Patients with RDD who are treatment-naive or have not previously received lenalidomide; aged 18-80 years; ECOG PS 0-2.
干预措施: Lenalidomide (Drug)
Patients with RDD
Experimental
Patients with RDD who are treatment-naive or have not previously received lenalidomide; aged 18-80 years; ECOG PS 0-2.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Progression-free survival time （PFS)
时间窗: From enrollment to the end of treatment at 8 weeks
PFS defined as the time from RD initiation to first documented disease progression, relapse after RD, death from any cause, or last follow-up.
次要结局
- Overall Response Rate (ORR)(From enrollment to the end of treatment at 8 weeks)
- Overall Survival (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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