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
NCT ID: NCT05954910
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1000 participants
OBSERVATIONAL
2023-08-25
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
Polatuzumab Vedotin
Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.
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).
Polatuzumab Vedotin
Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.
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).
Polatuzumab Vedotin
Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.
Interventions
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Polatuzumab Vedotin
Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Peking Union Medical College Hospital
Beijing, , 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, , 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, , China
Jiangxi Cancer Hospital
Nanchang, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, , China
Jiangsu Cancer Hospital
Nanjing, , China
The Affiliated Hospital Of Qingdao University
Qingdao, , China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, , China
Tongji Hospital of Tongji University
Shanghai, , China
China Medical University (CMU) First Affiliated Hospital
Shenyang, , China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, , China
Shanxi Province Cancer Hospital
Taiyuan, , China
Tianjin Medical University General Hospital
Tianjin, , China
Tianjin Cancer Hospital
Tianjin, , China
Xinjiang Medical University Cancer Hospital
Ürümqi, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , 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
Countries
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Other Identifiers
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ML44616
Identifier Type: -
Identifier Source: org_study_id
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