Zanubrutinib and Lenalidomide as Maintenance Therapy in Patients With Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- EFS
研究概览
简要总结
The goal of this phase 2 trial is to test the safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with DLBCL.
详细描述
The investigators will evaluate safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with diffuse large B-cell lymphoma post complete remission and have completed planed courses of chemotherapy . Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification;
- •Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- •Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
- •Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
- •Patient has recieved complete remission and has completed planed courses of chemotherapy
- •Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10^9/L (≥ 1 x 10^9/L if bone marrow (BM) involvement by lymphoma)；Platelet ≥ 75 x 10^9/L (≥ 50 x 10^9/L if BM involvement by lymphoma)； Hemoglobin ≥ 8 g/dL. Anticipated life expectancy at least 3 months
排除标准
- •Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
- •Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;
- •Pregnant or lactating women
研究组 & 干预措施
Maintenance Therapy
Patients were treated by Zanubrutinib plus Lenalidomide as Maintenance Therapy
干预措施: Zanubrutinib plus Lenalidomide as Maintenance Therapy (Drug)
结局指标
主要结局
EFS
时间窗: 2 years
EFS was defined as the time from treatment initiation to progression, relapse, new treatment, or death by any cause, whichever occurred first.
次要结局
- PFS(2 years)
- OS(2 years)
研究者
Liren Qian
Vice Director
Navy General Hospital, Beijing