NCT04924647招募中2 期
Lenalidomide and Dexamethasone for Rosai-Dorfman Disease: A Single Arm, Single Center, Prospective Phase 2 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Event-free survival
研究概览
简要总结
Rosai-Dorfman Disease (RDD) is a rare, heterogeneous histiocytic disorder. Because of the rarity of RDD and a lack of prospective randomized trials, the treatment strategy for RDD is mostly based on retrospective study. Steroid was suggested as frontline treatment as RDD with only lymph nodes involvement. Studies showed thalidomide or lenalidomide showed some effect in recurrent/refractory skin RDD. The investigators want to analyze the efficacy and toxicity of lenalidomide combined with dexamethasone regimens in the treatment of RDD among adult patients at our hospital.
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
- •Histologically confirmed diagnosis of RDD
- •Age ≥18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Patients must have adequate renal, liver, and bone marrow function as defined by the following criteria:
- •Absolute neutrophil count ≥1500 cells per mm3 Platelet count ≥100000 cells per mm3 Creatinine clearance [according to Cockcroft formula] ≥60 mL/min. Aspartate aminotransferase and alanine aminotransferase ≤2·5×upper limit of normal [ULN], and total bilirubin ≤2·5×ULN; or ≤10×ULN in the case of known liver involvement by RDD.
- •No active or untreated infection.
- •No cardiac abnormalities.
- •Subject provide written informed consent.
- •A female is eligible to enter and participate in this study if she is of:
- •Non-childbearing potential including ω Any female who has had a surgical procedure rendering her incapable of becoming pregnant.
- •ω Subjects have experienced total cessation of menses for more than 1 year and be greater than 45 years in age.
- •⎫ Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, and agrees to use adequate contraception.
- •Male subjects must use an effective barrier method of contraception during the study and for 90 days following the last course of MA if sexually active with a childbearing potential
排除标准
- •Patients had concurrent malignancies.
- •History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day
- •Women who were pregnant or of childbearing potential.
- •Known HIV seropositive, active hepatitis C infection, and/or hepatitis B (defined as HCV RNA≥1000 copies or HBV DNA ≥1000 copies at screening).
- •Major surgical procedure within 28 days prior to the first dose of study treatment.
- •Presence of uncontrolled infection.
- •Evidence of active bleeding or bleeding diathesis.
- •Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
研究组 & 干预措施
RD
Experimental
lenalidomide and dexamethasone
干预措施: lenalidomide and dexamethasone (Drug)
结局指标
主要结局
Event-free survival
时间窗: the duration from initiation of treatment to the date of first documented event or date of death from any cause, whichever come first, assessed up to 5 years
Events were defined as a poor response to RD, reactivation after RD therapy and death from any cause.
次要结局
- Overall response rate(on 12 months)
- Overall survival(the duration from initiation of RD treatment to the date of death or last follow-up, assessed up to 5 years)
研究者
Cao Xinxin
Associate Professor
Peking Union Medical College Hospital
研究点 (1)
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