A Study to Evaluate the Effectiveness and Safety of Polatuzumab in Real World Clinical Practice Among Adult Chinese Participants With Diffuse Large B-Cell Lymphoma
- Registration Number
- NCT05954910
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 2 Polatuzumab Vedotin 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). Cohort 3 Polatuzumab Vedotin 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). Cohort 1 Polatuzumab Vedotin 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).
- Primary Outcome Measures
Name Time Method Cohort 3: PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma 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 At 24 months
- Secondary Outcome Measures
Name Time Method 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) AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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)
Trial Locations
- Locations (29)
Xinjiang Medical University Cancer Hospital
🇨🇳Urumqi City, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan City, China
Wuxi People's Hospital
🇨🇳Wuxi, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
🇨🇳Xi'an, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
The Affiliated Hospital Of Qingdao University
🇨🇳Qingdao, China
Peking Union Medical College Hospital
🇨🇳Beijing City, China
Peking University Third Hospital
🇨🇳Beijing, China
Beijing Hospital of Ministry of Health
🇨🇳Beijing, China
Beijing Tongren Hospital, Capital Medical University
🇨🇳Beijing, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, China
Xiangya Hospital of Centre-South University
🇨🇳Changsha, China
Third Xiangya Hospital of Central South University
🇨🇳Changsha, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
🇨🇳Chengdu City, China
Zhujiang Hospital, Southern Medical University
🇨🇳Guangzhou, China
Guizhou Cancer Hospital
🇨🇳Guiyang, China
Hainan Cancer Hospital
🇨🇳Haikou, China
Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot City, China
Jiangxi Cancer Hospital
🇨🇳Nanchang City, China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
🇨🇳Nanjing City, China
Jiangsu Cancer Hospital
🇨🇳Nanjing City, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai City, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, China
China Medical University (CMU) First Affiliated Hospital
🇨🇳Shenyang City, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
Shanxi Province Cancer Hospital
🇨🇳Taiyuan City, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
Tianjin Cancer Hospital
🇨🇳Tianjin, China