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

Roche

Status: Active, not recruiting

Conditions: Diffuse Large B-Cell Lymphoma

Treatments: Drug: Polatuzumab Vedotin

Study type: Observational

Funder types: Industry

Identifiers

NCT05954910

ML44616

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 3 patient groups

Cohort 1

Description:

Unfit/frail participants with DLBCL who are untreated before the administration of polatuzumab and who have started receiving polatuzumab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 3 years).

Treatment:

Drug: Polatuzumab Vedotin

Cohort 2

Description:

Participants with DLBCL who can not be classified into unfit/frail but are untreated before the administration of polatuzumab and who have started receiving polatuzumab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 3 years).

Treatment:

Drug: Polatuzumab Vedotin

Cohort 3

Description:

Participants with relapsed or refractory (R/R) DLBCL who have started receiving polatuzumab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 3 years).

Treatment:

Drug: Polatuzumab Vedotin