Clareo Health | Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma
Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma
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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest diameter
Adequate hematologic function
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2; with the exception of South Korea, where participants 80 years or older with ECOG \>/= 2 will not be eligible
Participants in Cohort A must also meet the following criteria for study entry:
Histologically confirmed DLBCL according to World Health Organization (WHO) 2016 expected to express the cluster of differentiation-20 (CD20) antigen
One prior therapy with any systemic anthracycline-based chemoimmunotherapy containing regimen for previously untreated DLBCL
Best response of SD or PR to prior systemic chemoimmunotherapy at the end of induction treatment in accordance with the Lugano 2014 criteria
Participants in Cohorts B and C must also meet the following criteria for study entry:
Previously untreated, histologically confirmed, DLBCL according to WHO 2016 classification
Age \>/= 80 years, or
Age 65-79 years and considered ineligible for chemoimmuotherapy (R-CHOP) with at least one of the following: Impairment in at least two activity of daily living (ADL) components as defined in the protocol; impairment in at least two instrumental ADL components as defined in the protocol; cumulative illness rating scale - geriactic (CIRS-G) score of at least one cormorbidity with a severity score of 3-4 (not including lymphoma and hematologic deficiencies due to lymphoma) or a score of 2 in \>/= 8 comorbidities; impairment in cardiac function, renal function, liver function, or other comorbidities such that the participant is unfit for full-dose immunochemotherapy, such as rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)
Participants with an initial ECOG performance status of 3 may be considered during screening if the performance status is DLBCL-related and if pre-phase treatment during the screening phase (not more than 100 mg/day up to 7 days prior to Cycle 1 Day 1) results in an improvement of ECOG performance status to \</= 2 prior to enrollment
You may not be if
Participants who meet any of the following criteria will be excluded from study entry:
Transformed lymphoma
CNS lymphoma
Prior treatment with mosunetuzumab
Prior stem cell transplant (autologous and allogeneic)
History of confirmed progressive multifocal leukoencephalopathy (PML)
Known or suspected chronic active Epstein Barr virus (CAEBV), hepatitis B, hepatitis C (HCV), or Human Immunodeficiency Virus (HIV)
Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
Positive SARS-CoV-2 antigen or PCR test within 30 days prior to Cycle 1 Day 1
Prior solid organ transplantation
Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
Clinically significant history of liver disease
Prior treatment with radiotherapy within 2 weeks prior to Cycle 1, Day 1 (C1D1)
Significant cardiovascular disease
Participants in Cohort A who meet the following criteria will be excluded from study entry:
\- Prior anti-lymphoma treatment with chemotherapy, immunotherapy, or biologic therapy 4 weeks prior to C1D1
Exclusion Criterion Specific to Cohorts B and C
Participants in Cohorts B and C who meet the following criterion will be excluded from study entry:
\- Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy
Participants in Cohort C who meet the following criteria will be excluded from study entry:
\- Current Grade \>1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
