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NCT Number: NCT05954910

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 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.

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Hospital of Ministry of Health, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polatuzumab Vedotin

Drug

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

Other names: POLIVY ®

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

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

    Time frame: At 24 months

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ML44616 https://forpatients.roche.com/

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2023
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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