About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Polatuzumab Vedotin
DrugPolatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.
Treatment groups
Trial outcomes
Primary outcomes
Cohorts 1 and 2: Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Cohort 3: PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Secondary outcomes
Cohort 3: PFS24 Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Cohorts 1, 2 and 3: Time to Next Treatment (TTNT)
Cohorts 1, 2 and 3: Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Cohorts 1, 2 and 3: Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Sponsors and contacts
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