A RANDOMIZED, OPEN-LABEL, MULTICENTER PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF MOSUNETUZUMAB IN COMBINATION WITH POLATUZUMAB VEDOTIN IN COMPARISON WITH RITUXIMAB IN COMBINATION WITH GEMCITABINE PLUS OXALIPLATIN IN PARTICIPANTS WITH RELAPSED OR REFRACTORY AGGRESSIVE

Phase 3

• Conditions: C833 Diffuse large B-cell lymphoma; Diffuse large B-cell lymphoma; C833

• Registration Number: PER-070-21
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-11
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: In enrollment
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Participants who have measurable disease, defined as at least 1 bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least 1 bi-dimensionally measurable extra nodal lesion, defined as > 1.0 cm in its longest dimension

Participants who have CD20+ aggressive lymphoma as determined by the local hematopathology laboratory from the following diagnoses by 2016 World Health Organization classification of lymphoid neoplasms:
– DLBCL, not otherwise specified (NOS)
– High-grade B-cell lymphoma (NOS or double/triple hit)
– trFL: The disease must be R/R to standard therapies for trFL
– FL3B

Participants who have a pathology report for the initial histopathology diagnosis and the most recent histopathology diagnosis prior to entering the study
– Participants with trFL must also have a pathology report completed at the time of disease transformation

Participants who are capable of giving signed informed consent as described in protocol Appendix 1, which includes compliance with the requirements and restrictions listed in the Informed Consent Form and in this protocol

Participants who are age = 18 years at the time of signing Informed Consent Form

Participants who have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 (protocol Appendix 12)

Participants who have a life expectancy of at least 12 weeks

Participants who have received at least one prior systemic therapy for aNHL

Participants who have either relapsed or have become refractory to a prior regimen must meet the following criteria:
– Relapsed to prior regimen(s) after having a documented history of response (CR or PR) of = 6 months in duration from completion of regimen(s)
– Refractory to any prior regimen, defined as no response to the prior therapy, or progression within 6 months of completion of the last dose of therapy.

Participants who have received only one prior line of therapy must be ineligible for ASCT

Participants who have adequate hepatic, hematologic, and renal functions defined by laboratory values below:
– Hepatic function
AST and ALT = 2,5 x upper limit of nor

Exclusion Criteria

Participants who have a history of HIV infection

Participants who have had solid organ transplantation

Participants who have a known or suspected history of HLH

Participants who have a history of confirmed progressive multifocal leukoencephalopathy

Participants who have a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombination antibody-related fusion proteins)

Participants who currently have or have had a past history of CNS involvement of lymphoma

Participants who have a history of CNS disease which was symptomatic or required treatment in the past 1 year, such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease

Participants who have a clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis

Participants who have a known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of the 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 2 weeks prior to the first study treatment administration

Participants who have a known or suspected chronic active Epstein-Barr virus (EBV) infection

Participants who have had a recent major surgery within 4 weeks prior to the first study treatment administration
Protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies) are permitted.

Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab, 9 months after the final dose of polatuzumab vedotin, 12 months after the final dose of rituximab, 6 months after the final dose of gemcitabine, 9 months after the final dose of oxaliplatin, and 3 months after the final dose of tocilizumab, as applicable.
Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determined by the IRF with use of the Lugano 2014 Response criteria.<br> NAME OF THE RESULT: Progression-free survival (PFS)<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: From randomization to the<br>first occurrence of disease progression or death due to any cause, whichever occurs first