Phase 2 Study of Zanubrutinib Plus RCHOP (ZR-CHOP) in Newly Diagnosed Diffuse Large B-cell Lymphoma With Specific Gene Abnormality
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 3-year progression free survival
研究概览
简要总结
This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality.
详细描述
This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality, including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation. all patients received 6 cycle therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-75 years old;
- •histological confirmed, newly-diagnosed diffuse large B-cell lymphoma with one of the following gene abnormality including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation;
- •Eastern Cooperative Oncology Group (ECOG) status of 0-1; 4) hospitalized patients and received the whole cycle treatment in Fudan University Shanghai Cancer Center-
- •normal hematological, hepatic and renal function.
- •Life expectancy of more than 3 months;
- •Patients had at least one measurable target lesion;
- •signed informed consent forms
排除标准
- •hypersensitivity to immunoglobulin;
- •primary central nerves lymphoma
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
- •With contraindication of steroid including uncontrolled diabetes;
- •Serious uncontrolled diseases and intercurrent infection;
- •Pregnant or lactating women;
- •hepatitis B infection with HBV-DNA ≥ 104
研究组 & 干预措施
ZR-CHOP
干预措施: zanubrutinib (Drug)
结局指标
主要结局
3-year progression free survival
时间窗: assessed up to 36 months
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
次要结局
- 3-year overall survival(assessed up to 36 months)
- Objective response rate(assessed up to 36 months)
- 3-year event free survival(assessed up to 36 months)
研究者
Junning Cao, MD
Principal Investigator
Fudan University