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
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
1 other identifier
observational
1,000
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Typical duration for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2023
CompletedFirst Posted
Study publicly available on registry
July 20, 2023
CompletedStudy Start
First participant enrolled
August 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
May 1, 2026
April 1, 2026
3.8 years
July 12, 2023
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Cohorts 1 and 2: Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
At 24 months
Cohort 3: PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Baseline up to end of study (EOS) (approximately 38 months)
Secondary Outcomes (10)
Cohort 3: PFS24 Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
At 24 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, 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 and 2: Disease Control Rate (DCR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Baseline up to EOS (approximately 38 months)
- +5 more secondary outcomes
Study Arms (3)
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).
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).
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).
Interventions
Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.
Eligibility Criteria
Participants who will be treated with polatuzumab (known as being recommended and having the intention to be treated with polatuzumab at the time of signing informed consent) or have initiated polatuzumab treatment within three months prior to enrollment and after the indication approval will be observed in this study.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Peking Union Medical College Hospital
Beijing, 100032, China
Peking University Third Hospital
Beijing, 100191, China
Beijing Hospital of Ministry of Health
Beijing, 100730, China
Beijing Tongren Hospital, Capital Medical University
Beijing, 100730, China
The First Bethune Hospital of Jilin University
Changchun, China
Xiangya Hospital of Centre-South University
Changsha, 410008, China
Third Xiangya Hospital of Central South University
Changsha, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, 610072, China
Zhujiang Hospital, Southern Medical University
Guangzhou, 510280, China
Guizhou Cancer Hospital
Guiyang, 550004, China
Hainan Cancer Hospital
Haikou, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, 010000, China
Jiangxi Cancer Hospital
Nanchang, 330029, China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, 210029, China
Jiangsu Cancer Hospital
Nanjing, 211100, China
The Affiliated Hospital Of Qingdao University
Qingdao, DUMMY_VALUE, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
Tongji Hospital of Tongji University
Shanghai, 200065, China
China Medical University (CMU) First Affiliated Hospital
Shenyang, 110001, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Shanxi Province Cancer Hospital
Taiyuan, 030013, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Tianjin Cancer Hospital
Tianjin, 300060, China
Xinjiang Medical University Cancer Hospital
Ürümqi, 830011, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022, China
Wuxi People's Hospital
Wuxi, 214023, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Henan Cancer Hospital
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2023
First Posted
July 20, 2023
Study Start
August 25, 2023
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing