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

April 30, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100191
        • Peking University Third Hospital
      • Beijing, China, 100032
        • Peking Union Medical College Hospital
      • Beijing, China, 100730
        • Beijing Hospital of Ministry of Health
      • Beijing, China, 100730
        • Beijing Tongren Hospital, Capital Medical University
      • Changchun, China
        • The First Bethune Hospital of Jilin University
      • Changsha, China
        • Third Xiangya Hospital of Central South University
      • Changsha, China, 410008
        • Xiangya Hospital of Centre-South University
      • Chengdu, China, 610072
        • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
      • Guangzhou, China, 510280
        • Zhujiang Hospital, Southern Medical University
      • Guiyang, China, 550004
        • Guizhou Cancer Hospital
      • Haikou, China
        • Hainan Cancer Hospital
      • Hohhot, China, 010000
        • Affiliated Hospital of Inner Mongolia Medical University
      • Nanchang, China, 330029
        • Jiangxi Cancer Hospital
      • Nanjing, China, 211100
        • Jiangsu Cancer Hospital
      • Nanjing, China, 210029
        • Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
      • Qingdao, China, DUMMY_VALUE
        • The Affiliated Hospital of Qingdao University
      • Shanghai, China, 200025
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine
      • Shanghai, China, 200065
        • Tongji Hospital of Tongji University
      • Shenyang, China, 110001
        • China Medical University (CMU) First Affiliated Hospital
      • Shijiazhuang, China
        • The Fourth Hospital of Hebei Medical University
      • Taiyuan, China, 030013
        • Shanxi Province Cancer Hospital
      • Tianjin, China, 300060
        • Tianjin Cancer Hospital
      • Tianjin, China, 300052
        • Tianjin Medical University General Hospital
      • Wuhan, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuxi, China, 214023
        • Wuxi People's Hospital
      • Xi'an, China, 710061
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
      • Xuzhou, China
        • The Affiliated Hospital of Xuzhou Medical University
      • Zhengzhou, China
        • Henan Cancer Hospital
      • Ürümqi, China, 830011
        • Xinjiang Medical University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Drug: Polatuzumab Vedotin
Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.
Other Names:
  • POLIVY ®
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).
Drug: Polatuzumab Vedotin
Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.
Other Names:
  • POLIVY ®
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).
Drug: Polatuzumab Vedotin
Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.
Other Names:
  • POLIVY ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cohorts 1 and 2: Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time Frame: At 24 months
At 24 months
Cohort 3: PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time Frame: Baseline up to end of study (EOS) (approximately 38 months)
Baseline up to end of study (EOS) (approximately 38 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 3: PFS24 Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time Frame: At 24 months
At 24 months
Cohorts 1, 2 and 3: Time to Next Treatment (TTNT)
Time Frame: From the start of polatuzumab treatment to the initiation of next-line treatment (up to approximately 38 months)
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
Time Frame: Baseline up to EOS (approximately 38 months)
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
Time Frame: Baseline up to EOS (approximately 38 months)
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
Time Frame: Baseline up to EOS (approximately 38 months)
Baseline up to EOS (approximately 38 months)
Cohorts 1, 2 and 3: Duration of Response (DoR)
Time Frame: 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)
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: Disease Free Survival (DFS)
Time Frame: 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)
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)
Cohorts 1 and 2: Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time Frame: 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)
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: Overall Survival (OS)
Time Frame: From the start of polatuzumab treatment until the date of death from any cause (up to approximately 38 months)
From the start of polatuzumab treatment until the date of death from any cause (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)
Time Frame: 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.
Up to EOS (approximately 38 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2023

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML44616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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