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).

NCT ID: NCT04236141

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-10
• Study Completion Date: 2022-02-07

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).

Conditions

Diffuse, Large B-Cell, Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Polatuzumab Vedotin plus BR

Group Type: EXPERIMENTAL

Polatuzumab Vedotin

Intervention Type: DRUG

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.

Bendamustine

Intervention Type: DRUG

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.

Rituximab

Intervention Type: DRUG

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.

Placebo plus BR

Group Type: ACTIVE_COMPARATOR

Bendamustine

Intervention Type: DRUG

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.

Rituximab

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

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.

Interventions

Polatuzumab Vedotin

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

Bendamustine

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

Rituximab

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

Placebo

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

YO41543

Identifier Type: -

Identifier Source: org_study_id