Loading clinical trials...

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). | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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).

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.

NCT04236141•Hoffmann-La Roche

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+2 more criteria

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.
+15 more criteria

Locations (10)

Beijing Cancer Hospital

Beijing, China

West China Hospital, Sichuan University

Chengdu, China

Sun Yet-sen University Cancer Center

Guangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

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

Nanjing, China

Jiangsu Cancer Hospital

Nanjing, China

Fudan University Shanghai Cancer Center

Shanghai, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

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

Xi'an, China

Henan Cancer Hospital

Zhengzhou, China

Key Dates

Start Date

July 10, 2020

Primary Completion Date

July 12, 2021

Completion Date

February 7, 2022

Last Updated

March 3, 2023

Enrollment

ACTUAL participants

Conditions

Diffuse, Large B-Cell, Lymphoma

Interventions

Polatuzumab Vedotin

DRUG

Bendamustine

DRUG

Rituximab

DRUG

Placebo

DRUG

Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients

NCT02374424

Diffuse, Large B-Cell, Lymphoma

View study

COMPLETEDPHASE3

A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients

NCT02867566

Diffuse, Large B-Cell, Lymphoma

View study

COMPLETEDPHASE2

Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions