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A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).

Primary Purpose

Diffuse, Large B-Cell, Lymphoma

Status

Terminated

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Polatuzumab Vedotin

Bendamustine

Rituximab

Placebo

About this trial

This is an interventional treatment trial for Diffuse, Large B-Cell, Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Able to comply with the study protocol and procedures, in the investigator's judgement.
Transplant ineligible participants with R/R DLBCL.
Confirmed DLBCL diagnosis.
For participants who have received prior bendamustine, a response duration > 1 year (for participants who have relapsed disease after a prior regimen).
At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or magnetic resonance imaging (MRI).
Availability of archival or freshly collected tumor tissue before study enrolment.
Life expectancy of at least 24 weeks.
ECOG Performance Status of 0, 1 or 2.
Adequate haematologic function.
Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
For men who are not surgically sterile: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm.
Residence in the People's Republic of China.

Exclusion Criteria:

History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (MAbs) or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products.
Contraindication to bendamustine or rituximab.
History of sensitivity to mannitol (mannitol is an excipient in bendamustine).
Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 5 half-lives or 4 weeks, whichever is longer, before Cycle 1, Day 1.
Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1, Day 1.
Ongoing corticosteroid use > 30 mg/day prednisone or equivalent, for purposes other than lymphoma symptom control.
Completion of autologous SCT within 100 days prior to Cycle 1, Day 1.
Prior allogeneic Stem Cell Transplantation (SCT).
Prior treatment with Chimeric Antigen Receptor (CAR) T-cell therapy.
Eligibility for autologous SCT.
Grade 3b Follicular Lymphoma (FL).
History of transformation of indolent disease to DLBCL.
Primary or secondary CNS lymphoma.
Current Grade > 1 peripheral neuropathy.
History of other malignancy that could affect compliance with the protocol or interpretation of results.
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular or pulmonary disease.
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1.
Participants with suspected or latent tuberculosis.
Positive Chronic Hepatitis B (HBV) infection or Hepatitis C (HCV) infection.
Known history of HIV infection.
Known infection human T-cell leukemia virus 1 virus.
Vaccination with a live vaccine within 28 days prior to treatment.
Recent major surgery (within 6 weeks before the start of Cycle 1, Day 1) other than for diagnosis.
Pregnant or breastfeeding or intending to become pregnant during the study or within 12 months after the final dose of study treatment.
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.

Sites / Locations

Beijing Cancer Hospital
West China Hospital, Sichuan University
Sun Yet-sen University Cancer Center
Harbin Medical University Cancer Hospital
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Jiangsu Cancer Hospital
Fudan University Shanghai Cancer Center
Union Hospital Tongji Medical College Huazhong University of Science and Technology
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Henan Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Polatuzumab Vedotin plus BR

Placebo plus BR

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Complete Response (CR) at the End of Treatment (EOT) Assessment Based on Positron Emission Tomography-Computed Tomography (PET-CT) Assessed by Independent Review Committee (IRC)

CR was determined by IRC according to the Lugano Response Criteria (LRC) for Malignant Lymphoma. Per LRC , CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment.

Secondary Outcome Measures

Percentage of Participants With CR at the EOT Assessment Based on PET-CT as Assessed by Investigator

CR was determined by investigator according to the LRC for Malignant Lymphoma. Per LRC, CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5PS, where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment. Percentages have been rounded off to the first decimal point.

Percentage of Participants With Objective Response (OR) at EOT Based on PET-CT as Assessed by Investigator

OR was defined as CR or partial response (PR) at the end of treatment assessment based on PET-CT, as determined by the investigator according to the LRC. CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass on 5PS, where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. PR based on PET-CT was defined as partial MR in lymph nodes and extralymphatic sites with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size; no new lesions and residual uptake higher than uptake in normal bone marrow but reduced compared with baseline. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment.

Percentage of Participants With OR at EOT Based on PET-CT as Assessed by IRC

OR was defined as CR or PR at the end of treatment assessment based on PET-CT, as determined by the IRC according to the LRC. CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass on 5PS, where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. PR per PET-CT was defined as partial MR in lymph nodes and extralymphatic sites with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size; no new lesions and residual uptake higher than uptake in normal marrow but reduced compared with baseline. The analysis was done 6-8 weeks after Cycle 6, Day 1(1 cycle= 21 days) or after final dose of study treatment.Percentages have been rounded off to the first decimal point.

Percentage of Participants With CR at EOT Based on Computed Tomography (CT) as Assessed by Investigator

CR was determined by the investigator according to the LRC. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, immunohistochemistry (IHC) negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment.

Percentage of Participants With CR at EOT Based on CT as Assessed by IRC

CR was determined by the IRC according to the LRC. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment.

Percentage of Participants With OR at EOT Assessment Based on CT as Assessed by Investigator

OR was defined as CR or PR, at the EOT assessment based on CT only, as determined by the investigator according to the LRC. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. Per LRC, PR was defined as ≥ 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target nodes and extranodal sites; non-measured lesion is absent/normal, regressed, but no increase; spleen must have regressed by >50 % in length beyond normal; and no new lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment. Percentages have been rounded off to the first decimal point.

Percentage of Participants With OR at EOT Assessment Based on CT as Assessed by IRC

OR was defined as percentage of participants with CR or PR, at EOT assessment based on CT only, as determined by IRC according to the LRC. Per LRC, CR based on CT was defined as complete radiologic response with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi. PR is ≥ 50% decrease in SPD of up to 6 target nodes and extranodal sites. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment.

Percentage of Participants With Best Overall Response (BOR) Based on PET-CT or CT Only as Assessed by Investigator

BOR=CR/PR per PET-CT/CT by investigator per LRC.CR perPET-CT=complete MR in lymph nodes & extralymphatic sites(ELS),score=1,2,3 with/without residual mass on5PS,1=no uptake(UT)above background;2=UT≤mediastinum;3=UT>mediastinum but ≤liver;4=UT moderately>liver;5=UT markedly higher than liver and/or new lesions; no new lesions & FDG-avid disease absent in bone marrow.CR perCT=complete radiologic response with target nodes/nodal masses regressedto≤1.5 cm in LDi&no ELS of disease;absence of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow morphology=normal,if indeterminate,IHC negative.PR per PET-CT=partial MR in lymph nodes&ELS,score=4or5,reduced UT than baseline(BL)&residual masses=any size;no new lesions&residual UT >UT in normal marrow,reduced than BL.PR per CT by LCR=≥50% decrease in SPD of up to 6 target nodes & extranodal sites;non-measured lesion=absent/normal,regressed,no increase;spleen=regressed by>50%in length beyond normal;no new lesions.

Percentage of Participants With Best Overall Response (BOR) Based on PET-CT or CT Only as Assessed by IRC

BOR=CR/PR per PET-CT/CT by IRC per LRC. CR per PET-CT=complete MR in lymph nodes& ELS, score=1, 2,3 with/without residual mass on 5PS, 1=no UT above background; 2=UT≤mediastinum; 3=UT>mediastinum but ≤liver; 4=UT moderately>liver; 5=UT markedly higher than liver and/or new lesions; no new lesions & FDG-avid disease absent in bone marrow.CR per CT=complete radiologic response with target nodes/nodal masses regressed to≤1.5 cm in LDi and no ELS of disease; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; bone marrow morphology=normal, if indeterminate, IHC negative. PR per PET-CT=partial MR in lymph nodes & ELS, score =4 or 5,reduced UT than baseline(BL)&residual masses=any size; no new lesions &residual UT >UT in normal marrow, reduced than BL.PR per CT by LCR=≥50% decrease in SPD of up to 6 target nodes& extranodal sites; non-measured lesion=absent/normal, regressed, no increase; spleen=regressed by>50% in length beyond normal; no new lesions.

Duration Of Response (DOR) Based on PET-CT/CT Only as Assessed by Investigator

DOR was defined as time from first occurrence of a documented objective response to disease progression, relapse or death from any cause, as determined by the investigator according to the LRC

DOR Based on PET-CT/CT Only as Assessed by IRC

DOR was defined as time from first occurrence of a documented objective response to disease progression, relapse or death from any cause, as determined by IRC according to the LRC.

Progression-Free Survival (PFS) Based on PET-CT/CT Only as Assessed by Investigator

PFS was defined as the period from date of randomization until the date of disease progression, relapse, or death from any cause based on PET-CT or CT only, as determined by the investigator according to the LRC.

PFS Based on PET-CT/CT Only as Assessed by IRC

PFS was defined as the period from date of randomization until the date of disease progression, relapse, or death from any cause based on PET-CT or CT only, as determined by IRC according to the LRC.

Event-Free Survival (EFS) Based on PET-CT or CT Assessed by Investigator

EFS was defined as the time from date of randomization to any treatment failure including disease progression, relapse, initiation of new anti-lymphoma treatment (NALT), or death based on PET-CT or CT only, as determined by the investigator according to the LRC.

Overall Survival (OS)

OS was defined as the time from date of randomization until the date of death from any cause.

Percentage of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition), recurrence of an intermittent medical condition not present at baseline, any deterioration in a laboratory value or other clinical test that is associated with symptoms or leads to a change in study treatment or concomitant treatment or discontinuation from study drug or adverse events that are related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment.

Serum Concentration of Total Antibody at Specified Timepoints

PK of polatuzumab vedodtin-related analyte- total antibody was measured

Plasma Concentration of Antibody-Conjugated Monomethyl Auristatin E (acMMAE) at Specified Timepoints

PK of polatuzumab vedodtin-related analyte- acMMAE was measured.

Plasma Concentration of Unconjugated Monomethyl Auristatin E (MMAE) at Specified Timepoints

PK of polatuzumab vedodtin-related analyte- unconjugated MMAE was measured.

Number of Participants With Positive Treatment Emergent Anti-Drug Antibodies (ADA) to Polatuzumab Vedotin

Treatment Emergent ADA is (a) negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result, OR (b) positive ADA result at baseline and one or more post-baseline titer results that are at least 0.60 titer unit (t.u.) greater than the baseline titer result.

Full Information

NCT ID

NCT04236141

First Posted

January 16, 2020

Last Updated

February 3, 2023

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT04236141

Brief Title

A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).

Official Title

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Terminated

Why Stopped

Sponsor's decision, no safety concerns

Study Start Date

July 10, 2020 (Actual)

Primary Completion Date

July 12, 2021 (Actual)

Study Completion Date

February 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

A study to evaluate the Efficacy and Safety of Polatuzumab Vedotin in combination with BR (Bendamustine and Rituximab) compared with BR alone in Chinese participants with R/R DLBCL. Approximately 42 Chinese participants will be randomised to treatment arms in a 2:1 ratio. Randomisation will be conducted with the aid of an interactive web-based response system (IxRS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse, Large B-Cell, Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Polatuzumab Vedotin plus BR

Arm Type

Experimental

Arm Title

Placebo plus BR

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Polatuzumab Vedotin

Intervention Description

Participants will receive a total of 6 cycles (a cycle being 21 days) of 1.8mg/kg Polatuzumab Vedotin (IV infusion) on Day 2 of Cycle 1 and Day 1 of Cycles 2-6.

Intervention Type

Drug

Intervention Name(s)

Bendamustine

Intervention Description

Participants will receive a total of 6 cycles (a cycle being 21 days) of 90 mg/m2 Bendamustine (IV infusion) on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6.

Intervention Type

Drug

Intervention Name(s)

Rituximab

Intervention Description

Participants will receive a total of 6 cycles (a cycle being 21 days) of 375 mg/m2 Rituximab (IV infusion) on Day 1 of each cycle.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will receive a total of 6 cycles (a cycle being 21 days) of Placebo (IV infusion) on Day 2 of Cycle 1 and Day 1 of Cycles 2-6.

Primary Outcome Measure Information:

Title

Description

Time Frame

Up to approximately 23 weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants With CR at the EOT Assessment Based on PET-CT as Assessed by Investigator

Description

Time Frame

Up to approximately to 23 weeks

Title

Percentage of Participants With Objective Response (OR) at EOT Based on PET-CT as Assessed by Investigator

Description

Time Frame

Up to approximately 23 weeks

Title

Percentage of Participants With OR at EOT Based on PET-CT as Assessed by IRC

Description

Time Frame

Up to approximately 23 weeks

Title

Percentage of Participants With CR at EOT Based on Computed Tomography (CT) as Assessed by Investigator

Description

Time Frame

Up to approximately 23 weeks

Title

Percentage of Participants With CR at EOT Based on CT as Assessed by IRC

Description

Time Frame

Up to approximately 23 weeks

Title

Percentage of Participants With OR at EOT Assessment Based on CT as Assessed by Investigator

Description

Time Frame

Up to approximately 23 weeks

Title

Percentage of Participants With OR at EOT Assessment Based on CT as Assessed by IRC

Description

Time Frame

Up to approximately 23 weeks

Title

Percentage of Participants With Best Overall Response (BOR) Based on PET-CT or CT Only as Assessed by Investigator

Description

Time Frame

Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks)

Title

Percentage of Participants With Best Overall Response (BOR) Based on PET-CT or CT Only as Assessed by IRC

Description

Time Frame

Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks)

Title

Duration Of Response (DOR) Based on PET-CT/CT Only as Assessed by Investigator

Description

DOR was defined as time from first occurrence of a documented objective response to disease progression, relapse or death from any cause, as determined by the investigator according to the LRC

Time Frame

Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks)

Title

DOR Based on PET-CT/CT Only as Assessed by IRC

Description

DOR was defined as time from first occurrence of a documented objective response to disease progression, relapse or death from any cause, as determined by IRC according to the LRC.

Time Frame

Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks)

Title

Progression-Free Survival (PFS) Based on PET-CT/CT Only as Assessed by Investigator

Description

Time Frame

Up to approximately 82 weeks

Title

PFS Based on PET-CT/CT Only as Assessed by IRC

Description

PFS was defined as the period from date of randomization until the date of disease progression, relapse, or death from any cause based on PET-CT or CT only, as determined by IRC according to the LRC.

Time Frame

Up to approximately 82 weeks

Title

Event-Free Survival (EFS) Based on PET-CT or CT Assessed by Investigator

Description

Time Frame

Up to approximately 82 weeks

Title

Overall Survival (OS)

Description

OS was defined as the time from date of randomization until the date of death from any cause.

Time Frame

Up to approximately 82 weeks

Title

Percentage of Participants With Adverse Events (AEs)

Description

Time Frame

Up to approximately 82 weeks

Title

Serum Concentration of Total Antibody at Specified Timepoints

Description

PK of polatuzumab vedodtin-related analyte- total antibody was measured

Time Frame

Predose & post dose on Day 2 of Cycle 1,& post dose on Days 8 & 15 of Cycles 1& 3; predose & post dose on Day 1 of Cycles 2, 3 & 4; treatment completion/early discontinuation visit; follow-up visits at Months 3 &6 (1 cycle=21 days) up to approx. 46 weeks

Title

Plasma Concentration of Antibody-Conjugated Monomethyl Auristatin E (acMMAE) at Specified Timepoints

Description

PK of polatuzumab vedodtin-related analyte- acMMAE was measured.

Time Frame

Predose and post dose on Day 2 of Cycle 1, and post dose on Days 8 and 15 of Cycles 1 and 3; predose and post dose on Day 1 of Cycles 2, 3 and 4; treatment completion/early discontinuation visit (each cycle = 21 days) up to approximately 19 weeks

Title

Plasma Concentration of Unconjugated Monomethyl Auristatin E (MMAE) at Specified Timepoints

Description

PK of polatuzumab vedodtin-related analyte- unconjugated MMAE was measured.

Time Frame

Title

Number of Participants With Positive Treatment Emergent Anti-Drug Antibodies (ADA) to Polatuzumab Vedotin

Description

Time Frame

Baseline up to approximately 39 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Able to comply with the study protocol and procedures, in the investigator's judgement. Transplant ineligible participants with R/R DLBCL. Confirmed DLBCL diagnosis. For participants who have received prior bendamustine, a response duration > 1 year (for participants who have relapsed disease after a prior regimen). At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or magnetic resonance imaging (MRI). Availability of archival or freshly collected tumor tissue before study enrolment. Life expectancy of at least 24 weeks. ECOG Performance Status of 0, 1 or 2. Adequate haematologic function. Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs. For men who are not surgically sterile: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm. Residence in the People's Republic of China. Exclusion Criteria: History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (MAbs) or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products. Contraindication to bendamustine or rituximab. History of sensitivity to mannitol (mannitol is an excipient in bendamustine). Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 5 half-lives or 4 weeks, whichever is longer, before Cycle 1, Day 1. Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1, Day 1. Ongoing corticosteroid use > 30 mg/day prednisone or equivalent, for purposes other than lymphoma symptom control. Completion of autologous SCT within 100 days prior to Cycle 1, Day 1. Prior allogeneic Stem Cell Transplantation (SCT). Prior treatment with Chimeric Antigen Receptor (CAR) T-cell therapy. Eligibility for autologous SCT. Grade 3b Follicular Lymphoma (FL). History of transformation of indolent disease to DLBCL. Primary or secondary CNS lymphoma. Current Grade > 1 peripheral neuropathy. History of other malignancy that could affect compliance with the protocol or interpretation of results. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular or pulmonary disease. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1. Participants with suspected or latent tuberculosis. Positive Chronic Hepatitis B (HBV) infection or Hepatitis C (HCV) infection. Known history of HIV infection. Known infection human T-cell leukemia virus 1 virus. Vaccination with a live vaccine within 28 days prior to treatment. Recent major surgery (within 6 weeks before the start of Cycle 1, Day 1) other than for diagnosis. Pregnant or breastfeeding or intending to become pregnant during the study or within 12 months after the final dose of study treatment. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

West China Hospital, Sichuan University

City

Chengdu

ZIP/Postal Code

610041

Country

China

Facility Name

Sun Yet-sen University Cancer Center

City

Guangzhou City

ZIP/Postal Code

510663

Country

China

Facility Name

Harbin Medical University Cancer Hospital

City

Harbin

ZIP/Postal Code

150081

Country

China

Facility Name

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

City

Nanjing City

ZIP/Postal Code

210029

Country

China

Facility Name

Jiangsu Cancer Hospital

City

Nanjing City

ZIP/Postal Code

211100

Country

China

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai City

ZIP/Postal Code

200120

Country

China

Facility Name

Union Hospital Tongji Medical College Huazhong University of Science and Technology

City

Wuhan City

ZIP/Postal Code

430023

Country

China

Facility Name

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

City

Xi'an

ZIP/Postal Code

710061

Country

China

Facility Name

Henan Cancer Hospital

City

Zhengzhou

ZIP/Postal Code

450008

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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