Mosunetuzumab Intravenous (IV)
DrugParticipants in cohorts A and B will receive IV mosunetuzumab.
NCT Number: NCT03677154
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Soroka Medical Center, Beersheba, Israel
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for All Cohorts
Inclusion criteria
Specific to Cohort A
Participants in Cohort A must also meet the following criteria for study entry:
Inclusion criteria
Specific to Cohorts B and C
Participants in Cohorts B and C must also meet the following criteria for study entry:
Exclusion criteria
for All Cohorts
Participants who meet any of the following criteria will be excluded from study entry:
Exclusion criteria
Specific to Cohort A
Participants in Cohort A who meet the following criteria will be excluded from study entry:
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:
Exclusion criteria
Specific to Cohort C
Participants in Cohort C who meet the following criteria will be excluded from study entry:
Participants in cohorts A and B will receive IV mosunetuzumab.
Participants in Cohort C will receive SC mosunetuzumab.
Participants in Cohort C will receive IV polatuzumab vedotin.
Participants will receive tocilizumab via IV as needed to manage severe cytokine release syndrome (CRS).
Time frame: Baseline through approximately 90 days after last study treatment
Time frame: 6-8 weeks after Cycle 8 Day 1 or the final dose of study treatment (cycle = 21 days)
Time frame: 6-8 weeks after Cycle 8 Day 1 or the final dose of study treatment (cycle = 21 days)
Time frame: 6-8 weeks after Cycle 8 Day 1 or the final dose of study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: 6-8 weeks after Cycle 8 Day 1 or the final dose of study treatment (cycle = 21 days)
Time frame: Baseline through 2 years after PRA (up to a total of approximately 2.5 years)
Time frame: Baseline through 2 years after PRA (up to a total of approximately 2.5 years)
Time frame: From the first occurrence of a documented objective response to disease progression, relapse, or death, whichever occurs first (up to approximately 2.5 years)
Time frame: From the first occurrence of a documented CR to disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 2.5 years)
Time frame: From the first study treatment to the first occurrence of disease progression, relapse, or death, whichever occurs first (up to approximately 2.5 years)
Time frame: From the first study treatment to death from any cause
Time frame: From the first study treatment to the first occurrence of disease progression, relapse, initiation of new anti-lymphoma treatment, or death from any cause, whichever occurs first (up to approximately 2.5 years)
Time frame: From the first study treatment to the first occurrence of disease progression, relapse, initiation of new anti-lymphoma treatment, or death from any cause, whichever occurs first (up to approximately 2.5 years)
Time frame: From the first study treatment to the first occurrence of disease progression, relapse, initiation of new anti-lymphoma treatment, or death from any cause, whichever occurs first (up to approximately 2.5 years)
Time frame: From the first study treatment to the first occurrence of disease progression, relapse, initiation of new anti-lymphoma treatment, or death from any cause, whichever occurs first (up to approximately 2.5 years)
Time frame: From the first study treatment to the first occurrence of disease progression, relapse, initiation of new anti-lymphoma treatment, or death from any cause, whichever occurs first (up to approximately 2.5 years)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Time frame: At pre-defined intervals from Cycle 1 Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Hoffmann-La Roche
Industry
A Phase I/II Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Patients With Diffuse Large B-Cell Lymphoma Following First-Line Immunotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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