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
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
18 Years and older, Male and Female
GO40554 (primary)
NCI-2019-00169
Summary
This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of
mosunetuzumab following first-line diffuse large B-cell lymphoma (DLBCL) immunochemotherapy
in participants with a best response of stable disease or partial response, or in
elderly/unfit participants with previously untreated DLBCL, or subcutaneous mosunetuzumab in
combination with polatuzumab vedotin IV in elderly/unfit participants with previously
untreated DLBCL.
Eligibility
- Inclusion Criteria for All Cohorts
- 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
Inclusion Criteria Specific to Cohort A
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
Inclusion Criteria Specific to Cohorts B and C
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 1 peripheral neuropathy by clinical examination or demyelinating form of
Charcot-Marie-Tooth disease
Treatment Sites in Georgia
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