The Effectiveness and Safety of Polatuzumab in Real-World Clinical Practice Among Chinese Adult Patients With Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter, Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 53
- 主要终点
- Cohort 3: PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
研究概览
简要总结
The purpose of this study is to assess the progression free survival (PFS) in the real-world settings of polatuzumab among Chinese diffuse large B cell lymphoma (DLBCL) participants.
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
- •Be diagnosed as DLBCL
- •Cohort 1: diagnosed as unfit/frail DLBCL. The unfit/frail is defined as aged 80 years or older, or younger than 80 years but with comorbidity and not tolerant to the standardized dose of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy according to investigator's judgment
- •Cohort 2: diagnosis as DLBCL but could not be classified into unfit/frail
- •Cohort 3: relapse or refractory to previous treatment
排除标准
- •Participant who currently participates in or with plan to participate in any interventional clinical trial
- •Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
研究组 & 干预措施
Cohort 2
Participants with DLBCL who can not be classified into unfit/frail but are untreated before the administration of polatuzumab and who have started receiving polatuzumab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 3 years).
干预措施: Polatuzumab Vedotin (Drug)
Cohort 3
Participants with relapsed or refractory (R/R) DLBCL who have started receiving polatuzumab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 3 years).
干预措施: Polatuzumab Vedotin (Drug)
Cohort 1
Unfit/frail participants with DLBCL who are untreated before the administration of polatuzumab and who have started receiving polatuzumab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 3 years).
干预措施: Polatuzumab Vedotin (Drug)
结局指标
主要结局
Cohort 3: PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
时间窗: Baseline up to end of study (EOS) (approximately 38 months)
Cohorts 1 and 2: Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
时间窗: At 24 months
次要结局
- Cohort 3: PFS24 Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma(At 24 months)
- Cohorts 1, 2 and 3: Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma(Baseline up to EOS (approximately 38 months))
- Cohorts 1, 2 and 3: Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma(Baseline up to EOS (approximately 38 months))
- Cohorts 1, 2 and 3: Overall Survival (OS)(From the start of polatuzumab treatment until the date of death from any cause (up to approximately 38 months))
- Cohorts 1, 2 and 3: Duration of Response (DoR)(From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 38 months))
- Cohorts 1 and 2: Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma(From the start of polatuzumab treatment to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first (up to approximately 38 months))
- Cohorts 1, 2 and 3: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)(Up to EOS (approximately 38 months))
- Cohorts 1, 2 and 3: Time to Next Treatment (TTNT)(From the start of polatuzumab treatment to the initiation of next-line treatment (up to approximately 38 months))
- Cohorts 1 and 2: Disease Control Rate (DCR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma(Baseline up to EOS (approximately 38 months))
- Cohorts 1 and 2: Disease Free Survival (DFS)(From the date of the first occurrence of a documented CR, to the date of relapse or death from any cause, whichever occurs first (up to approximately 38 months))