A Real-World Study on the Efficacy and Safety of Bispecific Antibody in the Treatment of Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Best Overall Response Rate (ORR)
研究概览
简要总结
B-cell non-Hodgkin lymphoma (B-NHL) is the most common type of lymphoma. Although first-line R-CHOP can cure a proportion of patients, approximately 30%-40% relapse or become refractory (R/R). CD20xCD3 bispecific antibodies, represented by glofitamab, have shown significant efficacy in clinical trials. However, large-scale real-world efficacy and safety data in Chinese clinical practice are still lacking, particularly regarding combination with different regimens and use in the relapsed population.
This is a prospective, multicenter, observational registry study evaluating the efficacy and safety of CD20xCD3 bispecific antibody-containing regimens in patients with relapsed or refractory B-cell non-Hodgkin lymphoma in a real-world setting. Efficacy is assessed using the Lugano 2014 response criteria. The primary endpoint is best objective response rate (ORR).
详细描述
Study design: Prospective, multicenter, observational (non-interventional) registry study.
Population: Patients aged >=18 years with histologically confirmed B-cell non-Hodgkin lymphoma who are relapsed or refractory after at least one prior line of therapy and who receive a CD20xCD3 bispecific antibody-containing regimen after study initiation.
Efficacy evaluation: Lugano 2014 response criteria.
Primary endpoint: Best objective response rate (ORR).
Secondary endpoints: Complete response rate (CRR), disease control rate (DCR), duration of response (DOR), time to next treatment (TTNT), progression-free survival (PFS), overall survival (OS), and safety.
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
- •Age >= 18 years at the start of treatment
- •Histologically confirmed B-cell non-Hodgkin lymphoma
- •Relapsed or refractory disease after at least one prior line of systemic therapy
- •Planned to receive a CD20xCD3 bispecific antibody-containing regimen after study initiation
- •Signed informed consent for the investigational treatment
排除标准
- •Currently participating in, or planning to participate in, any interventional clinical trial
- •Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study
结局指标
主要结局
Best Overall Response Rate (ORR)
时间窗: From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years
ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to the Lugano 2014 response criteria for malignant lymphoma.
次要结局
- Disease Control Rate (DCR)(From treatment initiation until disease progression, assessed up to approximately 2 years)
- Duration of Response (DOR)(From first response until disease progression or death, assessed up to approximately 2 years)
- Time to Next Treatment (TTNT)(From treatment initiation until start of next therapy or death, assessed up to approximately 2 years)
- Progression-Free Survival (PFS)(From treatment initiation until disease progression or death, assessed up to approximately 2 years)
- Overall Survival (OS)(From treatment initiation until death from any cause, assessed up to approximately 2 years)
- Incidence of Adverse Events (Safety)(From treatment initiation until 90 days after last dose, assessed up to approximately 2 years)
- Complete Response Rate (CRR)(From treatment initiation until disease progression or start of new therapy, assessed up to approximately 2 years)
研究者
Yanyan Liu
Professor
Henan Cancer Hospital