Diffuse Large B-Cell Lymphoma
Conditions
Brief 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.
Interventions
DRUGPolatuzumab Vedotin
Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 3: PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to end of study (EOS) (approximately 38 months) |
| Cohorts 1 and 2: Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | At 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohorts 1 and 2: Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | 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) | 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) | 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. |
| Cohort 3: PFS24 Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | At 24 months | — |
| Cohorts 1, 2 and 3: Time to Next Treatment (TTNT) | 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 | 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 | Baseline up to EOS (approximately 38 months) | — |
| Cohorts 1, 2 and 3: Duration of Response (DoR) | 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 Control Rate (DCR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to EOS (approximately 38 months) | — |
| Cohorts 1 and 2: Disease Free Survival (DFS) | 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) | — |
Countries
China
Contacts
CONTACTML44616 https://forpatients.roche.com/
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed