This is a two-arm, open-label, phase Ib single-site study with expansion cohorts testing the addition of mosunetuzumab to intensive platinum-based salvage chemotherapy in patients with relapsed/refractory aggressive B cell lymphoma. The hypothesis of this study is that mosunetuzumab can be safely combined with platinum-based salvage chemotherapy in this patient population, and that this approach may outperform chemoimmunotherapy approaches that instead incorporate rituximab retreatment. The enrolling physician's choice of the chemotherapy backbone will determine a patient's assigned study arm (Arm A = DHAX, Arm B = ICE). The two arms will accrue patients to phase Ib independently.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Provided by Genentech.
-Standard of care. Flexibility in administration is permitted at the discretion of the treating physician.
-Standard of care. Flexibility in administration is permitted at the discretion of the treating physician.
Washington University School of Medicine
St Louis, Missouri, United States
Frequencies and grades of treatment-emergent adverse events (TEAEs)
-Treatment-emergent adverse events (TEAE) are defined as adverse events possibly, probably, or definitely related to mosunetuzumab that occur on or after first dose of study treatment.
Time frame: From start of treatment through 30 days after administration of study treatment, or until initiation of alternate treatment for lymphoma, whichever occurs earlier (estimated to be 16 weeks)
Rate of treatment delay or discontinuation due to treatment-emergent adverse events (TEAEs)
-Treatment-emergent adverse events (TEAE) are defined as adverse events possibly, probably, or definitely related to mosunetuzumab that occur on or after first dose of study treatment.
Time frame: From start of treatment through 30 days after administration of study treatment, or until initiation of alternate treatment for lymphoma, whichever occurs earlier (estimated to be 12 weeks)
Number of participants with complete response (CR)
-As determined by PET-CT after Cycle 2 (PET2) of study treatment per Deauville 5-point scale (Lugano 2014 criteria).
Time frame: After cycle 2 (each cycle is 21 days; estimated to be 42 days)
Number of participants with partial response (PR)
-As determined by PET-CT after Cycle 2 (PET2) of study treatment per Deauville 5-point scale (Lugano 2014 criteria).
Time frame: After cycle 2 (each cycle is 21 days; estimated to be 42 days)
Overall response rate (ORR)
* ORR: Number of participants with complete response (CR) and partial response (PR) * As determined by PET-CT after Cycle 2 (PET2) of study treatment per Deauville 5-point scale (Lugano 2014 criteria).
Time frame: After cycle 2 (each cycle is 21 days; estimated to be 42 days)
Number of participants with stable disease (SD)
-As determined by PET-CT after Cycle 2 (PET2) of study treatment per Deauville 5-point scale (Lugano 2014 criteria).
Time frame: After cycle 2 (each cycle is 21 days; estimated to be 42 days)
Number of participants with progressive disease (PD)
-As determined by PET-CT after Cycle 2 (PET2) of study treatment per Deauville 5-point scale (Lugano 2014 criteria).
Time frame: After cycle 2 (each cycle is 21 days; estimated to be 42 days)
Progression-free survival (PFS)
-Defined as the time from start of study therapy to the first occurrence of disease progression as determined by the investigator with use of the Lugano Response Criteria or death from any cause.
Time frame: At 24 months
Progression-free survival (PFS)
-Defined as the time from start of study therapy to the first occurrence of disease progression as determined by the investigator with use of the Lugano Response Criteria or death from any cause.
Time frame: At 36 months
Progression-free survival (PFS)
-Defined as the time from start of study therapy to the first occurrence of disease progression as determined by the investigator with use of the Lugano Response Criteria or death from any cause.
Time frame: At 48 months
Overall survival (OS)
-Overall survival (OS) is defined as the time from start of study therapy to death from any cause.
Time frame: At 24 months
Overall survival (OS)
-Overall survival (OS) is defined as the time from start of study therapy to death from any cause.
Time frame: At 36 months
Overall survival (OS)
-Overall survival (OS) is defined as the time from start of study therapy to death from any cause.
Time frame: At 48 months
Percentage of participants requiring tocilizumab for management of cytokine release syndrome (CRS)
Tocilizumab is recommended for treatment of grade 2 CRS and required for grade 3 or 4 CRS. Tocilizumab should be administered by IV infusion for a maximum of 4 doses.
Time frame: Up to approximately 12 weeks
Number of total tocilizumab doses per participant for management of cytokine release syndrome (CRS)
Tocilizumab is recommended for treatment of grade 2 CRS and required for grade 3 or 4 CRS. Tocilizumab should be administered by IV infusion for a maximum of 4 doses.
Time frame: Up to approximately 12 weeks
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