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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHoffmann-La Roche

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Polatuzumab Vedotin

    Drug

    Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Cohort 11 intervention
Group B: Cohort 21 intervention
Group C: Cohort 31 intervention

Trial outcomes

Primary outcomes

1

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
2

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 outcomes

1

Cohort 3: PFS24 Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

Time frame
At 24 months
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.