B-cell non-Hodgkin lymphoma (NHL) MedDRA version: 20.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: Mosunetuzumab
Product Code: RO7030816/F02-01
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Mosunetuzumab
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for All Cohorts -Age >= 18 years - At least one bi-dimensionally measurable nodal lesion - Life expectancy of at least 24 weeks - Adequate hematologic function - Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2 -Use of contraception as defined by the protocol Inclusion criteria specific to Cohort A - Histologically confirmed DLBCL according to WHO 2016 classification - One prior systemic chemotherapy containing regimen for DLBCL - Best response of PR to prior systemic chemotherapy - Age >= 18 years - Left ventricular ejection fraction (LVEF) defined by multiple-gated acquisition /echocardiogram scan within the institutional limits of normal -- Use of contraception as defined by the protocol Inclusion criteria specific to Cohort B - Previously untreated, histologically confirmed, DLBCL according to WHO 2016 - - In the opinion of the investigator, unable to receive full-dose standard chemotherapy - Age greater than or equal 80 years or 60 to 79 years, as defined below: -The patient must have adequate end-organ function -For patients who are 60 to 79 years of age, at least one of the following: - Impairment in at least one activity of daily living or instrumental activity of daily living - Impairment in cardiac function, renal function, or liver function such that the patient is unable to tolerate full-dose immunochemotherapy, such as R-CHOP Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Exclusion Criteria for All Cohorts - Transformed lymphoma - Prior treatment with mosunetuzumab - Prior stem cell transplant (autologous and allogeneic) - Administration of a live, attenuated vaccine within 4 during a specified period - Prior solid organ transplantation - History of autoimmune disease - Received systemic immunosuppressive medications - Current or past history of central nervous system (CNS) disease - History of other malignancy - Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol - Known active bacterial, viral, fungal or other infection at study enrollment - Clinically significant history of liver disease - Recent major surgery within a specified period - Abnormal laboratory values - Prior treatment with radiotherapy - Adverse events from prior anti-cancer therapy not resolved to <= Grade 1 - Significant cardiovascular disease or significant pulmonary disease Exclusion Criteria Specific to Cohort A - Prior treatment with chemotherapy, immunotherapy, or biologic therapy within a specified period - Pregnant or breastfeeding, or intending to become pregnant during the study Exclusion Criterion Specific to Cohort B - Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): For Cohort A and B 1. Positron emission tomography–computed tomography (PET-CT) complete response rate 2. Incidence and severity of adverse events ; Main Objective: Cohort A • To make a preliminary assessment of the anti-tumor activity of mosunetuzumab in patients with best response of partial response (PR)following first-line therapy for Diffuse Large B-Cell Lymphoma (DLBCL) • To evaluate the safety, tolerability, and pharmacokinetics (PK) of mosunetuzumab in patients previously treated with first-line immunochemotherapy for DLBCL, including determination of the recommended dose for consolidation therapy Cohort B • To make a preliminary assessment of anti tumor activity of mosunetuzumab in patients unable to receive full dose, first-line immunochemotherapy • To evaluate the safety, tolerability, and PK of mosunetuzumab in patients with previously untreated DLBCL unable to tolerate immunochemotherapy ; Secondary Objective: • To make a preliminary assessment of efficacy of mosunetuzumab using measures other than complete response rate • To assess the immune response to mosunetuzumab and the potential effect of mosunetuzumab anti-drug antibody incidence on relevant clinical outcomes • To characterize the PK of mosunetuzumab and the relationship between serum PK, safety, biomarkers, and efficacy ;Timepoint(s) of evaluation of this end point: 1-2. Up to 60 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Objective response rate 2. Duration of response 3. Progression-free survival 4. Event-free survival 5. Incidence of Antidrug antibody (ADA) to mosunetuzumab 6. Relationship between ADAs and PK, safety, efficacy, and biomarkers may be explored as appropriate 7. Maximum serum concentration (Cmax) and minimum serum concentration (Cmin) of mosunetuzumab 8. Total exposure (area under the concentration-time curve [AUC]) of mosunetuzumab 9. Clearance of mosunetuzumab 10. Volume of distribution of mosunetuzumab 11. Relationship between serum pharmacokinetics and safety, biomarkers, or efficacy endpoints, as appropriate ; Timepoint(s) of evaluation of this end point: 1-4. Up to 60 months 5-6. Up to 60 weeks 7-11. Up to 60 weeks | — |
Countries
Israel, Poland, Spain, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed