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Diffuse Large B-Cell LymphomaNCT05954910

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

An observational study of Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 29 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
Polatuzumab Vedotin
How many people
1,000 participants
Where
29 sitesChina
Study dates
25 Aug 2023to 31 May 2027
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

China29 sites

  • Peking Union Medical College Hospital

    Beijing, 100032

  • Peking University Third Hospital

    Beijing, 100191

  • Beijing Hospital of Ministry of Health

    Beijing, 100730

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, 100730

  • The First Bethune Hospital of Jilin University

    Changchun

  • Xiangya Hospital of Centre-South University

    Changsha, 410008

  • Third Xiangya Hospital of Central South University

    Changsha

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, 610072

  • Zhujiang Hospital, Southern Medical University

    Guangzhou, 510280

  • Guizhou Cancer Hospital

    Guiyang, 550004

  • Hainan Cancer Hospital

    Haikou

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, 010000

  • Jiangxi Cancer Hospital

    Nanchang, 330029

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

    Nanjing, 210029

  • Jiangsu Cancer Hospital

    Nanjing, 211100

  • The Affiliated Hospital Of Qingdao University

    Qingdao, DUMMY_VALUE

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200025

  • Tongji Hospital of Tongji University

    Shanghai, 200065

  • China Medical University (CMU) First Affiliated Hospital

    Shenyang, 110001

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang

  • Shanxi Province Cancer Hospital

    Taiyuan, 030013

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Xinjiang Medical University Cancer Hospital

    Ürümqi, 830011

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022

  • Wuxi People's Hospital

    Wuxi, 214023

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

    Xi'an, 710061

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

About this study

Official title: 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.

Being tested
Polatuzumab Vedotin
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polatuzumab VedotinDrug

    Also called POLIVY ®

    Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.

Study groups in NCT05954910
Study groupRoleWhat they receive
Cohort 1Unfit/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).
Receives: Drug: Polatuzumab Vedotin
Cohort 2Participants 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).
Receives: Drug: Polatuzumab Vedotin
Cohort 3Participants 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).
Receives: Drug: Polatuzumab Vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohorts 1 and 2: Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

    Measured: At 24 months

  2. Cohort 3: PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

    Measured: Baseline up to end of study (EOS) (approximately 38 months)

Secondary outcomes (10)

  1. Cohort 3: PFS24 Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

    Measured: At 24 months

  2. Cohorts 1, 2 and 3: Time to Next Treatment (TTNT)

    Measured: From the start of polatuzumab treatment to the initiation of next-line treatment (up to approximately 38 months)

  3. Cohorts 1, 2 and 3: Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

    Measured: Baseline up to EOS (approximately 38 months)

  4. Cohorts 1, 2 and 3: Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

    Measured: Baseline up to EOS (approximately 38 months)

  5. Cohorts 1 and 2: Disease Control Rate (DCR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

    Measured: Baseline up to EOS (approximately 38 months)

  6. Cohorts 1, 2 and 3: Duration of Response (DoR)

    Measured: 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)

  7. Cohorts 1 and 2: Disease Free Survival (DFS)

    Measured: 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)

  8. Cohorts 1 and 2: Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

    Measured: 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)

  9. Cohorts 1, 2 and 3: Overall Survival (OS)

    Measured: From the start of polatuzumab treatment until the date of death from any cause (up to approximately 38 months)

  10. Cohorts 1, 2 and 3: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)

    AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Up to EOS (approximately 38 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2023
  2. Study start25 Aug 2023
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05954910
Sponsor's protocol ID
ML44616
Status last verified
Oct 2026
First submitted
12 Jul 2023
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

An observational study of Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 29 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05954910.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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