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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-25

Study Completion Date

2027-05-31

Brief Summary

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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

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Conditions

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Diffuse Large B-Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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POLIVY ®

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Peking University Third Hospital

Beijing, , China

Site Status

Beijing Hospital of Ministry of Health

Beijing, , China

Site Status

Beijing Tongren Hospital, Capital Medical University

Beijing, , China

Site Status

The First Bethune Hospital of Jilin University

Changchun, , China

Site Status

Xiangya Hospital of Centre-South University

Changsha, , China

Site Status

Third Xiangya Hospital of Central South University

Changsha, , China

Site Status

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, , China

Site Status

Zhujiang Hospital, Southern Medical University

Guangzhou, , China

Site Status

Guizhou Cancer Hospital

Guiyang, , China

Site Status

Hainan Cancer Hospital

Haikou, , China

Site Status

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, , China

Site Status

Jiangxi Cancer Hospital

Nanchang, , China

Site Status

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

Nanjing, , China

Site Status

Jiangsu Cancer Hospital

Nanjing, , China

Site Status

The Affiliated Hospital Of Qingdao University

Qingdao, , China

Site Status

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status

Tongji Hospital of Tongji University

Shanghai, , China

Site Status

China Medical University (CMU) First Affiliated Hospital

Shenyang, , China

Site Status

The Fourth Hospital of Hebei Medical University

Shijiazhuang, , China

Site Status

Shanxi Province Cancer Hospital

Taiyuan, , China

Site Status

Tianjin Medical University General Hospital

Tianjin, , China

Site Status

Tianjin Cancer Hospital

Tianjin, , China

Site Status

Xinjiang Medical University Cancer Hospital

Ürümqi, , China

Site Status

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, , China

Site Status

Wuxi People's Hospital

Wuxi, , China

Site Status

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, , China

Site Status

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, , China

Site Status

Henan Cancer Hospital

Zhengzhou, , China

Site Status

Countries

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China

Other Identifiers

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ML44616

Identifier Type: -

Identifier Source: org_study_id

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