Recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Polatuzumab Vedotin.
- Who it may be relevant to
- Registry conditions: Diffuse Large B-Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Polatuzumab Vedotin
Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.
Primary outcome measures
- 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]
- 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 outcome measures (10)
- Cohort 3: PFS24 Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Time frame: 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)]
- 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)]
- 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)]
- 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)]
- 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)]
- 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)]
- 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)]
- 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)]
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 29 centers
- Peking Union Medical College Hospital — Beijing
- Peking University Third Hospital — Beijing
- Beijing Hospital of Ministry of Health — Beijing
- Beijing Tongren Hospital, Capital Medical University — Beijing
- The First Bethune Hospital of Jilin University — Changchun
- Xiangya Hospital of Centre-South University — Changsha
- Third Xiangya Hospital of Central South University — Changsha
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital — Chengdu
- … and 21 more centers
Identifiers
NCT: NCT05954910 · ML44616