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 Type
OBSERVATIONAL
Enrollment
1,000
Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.
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)
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)
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Peking Union Medical College Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Beijing Hospital of Ministry of Health
Beijing, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
The First Bethune Hospital of Jilin University
Changchun, China
Xiangya Hospital of Centre-South University
Changsha, China
Third Xiangya Hospital of Central South University
Changsha, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, China
Zhujiang Hospital, Southern Medical University
Guangzhou, China
Guizhou Cancer Hospital
Guiyang, China
...and 19 more locations
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)
AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to EOS (approximately 38 months)