The Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin Lymphomas: a Real-world Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Describe the treatment of B-cell non-Hodgkin lymphoma patients who receive lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs), and evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting.
详细描述
This is a multi-center prospective, observational real-world study, targeting patients with B-cell non-Hodgkin's lymphomas. This study is designed to evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting.
This study will mainly focus on the following three cohorts:
Cohort 1: patients diagnosed with CD20-positive diffuse large B-cell lymphoma; Cohort 2: patients diagnosed with CD20-positive follicle lymphoma; Cohort 3: patients on maintenance treatment who have achieved complete remission or partial remission after induction therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as B-cell non-Hodgkin's lymphoma
- •Voluntary participation in this study and the signing of an informed consent form
- •The researchers assessed that the patient will benefit from the treatment of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs)
排除标准
- •Contradictions to any drug in the treatment regimen
- •Pregnant or lactating women
- •Patients who were not considered suitable for the study by the researchers
研究组 & 干预措施
DLBCL
Treatment-naive or relapsed/refractory CD20+ diffuse large B-cell lymphoma patients who receive induction therapy containing lenalidomide.
干预措施: Lenalidomide (Drug)
FL/MCL/MZL
Treatment-naive or relapsed/refractory CD20+ follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma patients who receive induction therapy containing lenalidomide.
干预措施: Lenalidomide (Drug)
Maintenance
B-cell non-Hodgkin lymphoma patients who achieve complete or partial remission after induction therapy and receive maintenance therapy containing lenalidomide.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Objective response rate
时间窗: At the end of Cycle 6 (each cycle is 21-28 days)
Rate of objective response, defined according to Lugano 2014 criterion.
次要结局
- Partial response rate(At the end of Cycle 6 (each cycle is 21-28 days))
- Overall survival(From entry onto study to study completion, an average of 2 years.)
- Complete response rate(At the end of Cycle 6 (each cycle is 21-28 days))
- Duration of response(From response evaluation to study completion, an average of 2 years.)
- 2-year progression-free survival(2 years after entry onto study)
- Adverse event(From entry onto study to study completion, an average of 2 years.)
- Severe adverse event(From entry onto study to study completion, an average of 2 years.)
- Dosage adjustment(From entry onto study to study completion, an average of 2 years.)
研究者
Zhao Weili
First Deputy Director of Shanghai Institute of Hematology
Ruijin Hospital