A Study of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Patients with Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Therapy in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma who are Unable to Tolerate Full-Dose Chemotherapy
- Conditions
- 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 disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2018-001127-40-ES
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 60
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 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method