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临床试验/NCT06170216
NCT06170216已完成不适用

A Single-center, Non-interventionary Clinical Study Evaluating the Efficacy and Safety of Different Immunochemotherapies in Small B-cell Non-Hodgkin Lymphoma (iNHL)

Fudan University2 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2023年1月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
206
试验地点
2
主要终点
ORR

研究概览

简要总结

Describe the application status of different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL), observe the therapeutic efficacy and safety of the treatment modalities.

详细描述

Evaluated the efficacy and safety of different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL)

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Age ≥ 18 years old
  • Initial or first recurrent iNHL confirmed by histopathology, including FL (1-3a), MZL, MCL;
  • Sign an informed consent form;
  • Researchers evaluate patients who can benefit from receiving immunochemotherapy.

排除标准

  • There are contraindications to any medication in the treatment plan;
  • Pregnant or lactating women or male and female participants of childbearing age did not take contraceptive measures during the trial period and within 30 days after the last medication;
  • Researchers believe that patients who are not suitable for enrollment.

研究组 & 干预措施

small B-cell non-Hodgkin lymphoma

Different immunochemotherapies in small B-cell non-Hodgkin lymphoma

干预措施: immunochemotherapies (Drug)

结局指标

主要结局

ORR

时间窗: up to 6 months

the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment

次要结局

  • 2-year event-free survival (EFS)(From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years)
  • 2-year progression-free survival (PFS)(From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
  • overall survival(From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years)
  • Hematology and non hematology toxicity(Throughout the treatment period,up to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yizhen Liu

Clinical Professor

Fudan University

研究点 (2)

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