CD20 positive B-Cell Non-Hodgkin Lymphoma MedDRA version: 23.1 Level: LLT Classification code 10084346 Term: B-cell non-Hodgkin's lymphoma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Glofitamab
Product Code: RO7082859/F04-01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Glofitamab
Current Sponsor code: RO7082859
Concentration unit: m
Sponsors
F.Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age 6 months to =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: ? Isolated CNS disease of mature B-NHL without systemic involvement, and primary central nervous system (CNS) lymphoma ? Receipt of glofitamab prior to study enrollment ? Ongoing adverse events from prior anti-cancer therapy that were not resolved to Grade =3 adverse events, with the exception of Grade 3 endocrinopathy managed with replacement therapy ? Prior solid organ transplantation ? Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) ? Known or suspected chronic active Epstein-Barr viral infection (CAEBV) ? Active autoimmune disease requiring treatment ? History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products ? History of confirmed progressive multifocal leukoencephalopathy ? Current or past history of uncontrolled non-malignant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease ? Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results ? Major surgery or significant traumatic injury =2 acute or extensive chronic graft -versus-host disease (GVHD) in participants who received prior allogeneic hematopoietic stem cell transplantation (HSCT) ?Prior treatment with systemic immunosuppressive agents for treatment of GVHD, within 4 weeks or five half-lives of the drug, whichever is shorter, before Cycle 1 Day 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To evaluate the efficacy of glofitamab in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) chemoimmunotherapy, as assessed by the investigator based on achievement of a complete response (CR) ? To evaluate the safety and tolerability of glofitamab in combination with R-ICE chemoimmunotherapy ? To determine the pharmacokinetics of glofitamab alone and in combination with R-ICE chemoimmunotherapy;Secondary Objective: ? To evaluate the anti-tumor activity of glofitamab in combination with R-ICE chemoimmunotherapy and glofitamab monotherapy ? To evaluate the safety and tolerability of glofitamab monotherapy ? To determine the pharmacokinetics of obinutuzumab and rituximab ? To evaluate the immune response to glofitamab;Primary end point(s): 1. Achievement of a complete response (CR) after up to three cycles of treatment as determined by the investigator according to the International Pediatric NHL Response Criteria for pediatric participants and Lugano Classification for young adult participants (glofitamab plus R-ICE chemoimmunotherapy) 2. Incidence, nature, frequency, severity, and timing of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0) (glofitamab plus R-ICE chemoimmunotherapy) 3. Change from baseline in physical findings, vital signs, clinical laboratory test results and electrocardiogram (ECG) (glofitamab plus R-ICE chemoimmunotherapy) 4. Pharmacokinetics (PK) parameters (as appropriate) and serum concentrations of glofitamab monotherapy at specified timepoints 5. PK parameters (as appropriate) and serum concentrations of glofitamab in combination with R-ICE chemoimmunotherapy at specified timepoints;Timepoint(s) of evaluation of this end point: 1. Up to 9 weeks 2. Up to approximately 3 years 3. Baseline to 3 years (Until D21 of last cycle for ECG and laboratory parameters) 4. At Days 1, 8, 15 of Cycle 1; Day 1 of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. For glofitamab plus R-ICE chemoimmunotherapy: Objective response rate (ORR), Duration of complete response (DOCR), Progression-free survival (PFS) after enrollment, Event-free survival (EFS), Overall survival (OS) and percentage of patients who proceed to HSCT after up to three cycles of treatment 2. For glofitamab monotherapy: ORR, Duration of response (DOR) and OS 3. Incidence, nature, frequency, severity, and timing of adverse events, with severity determined according to NCI CTCAE v5.0 (glofitamab monotherapy) 4. Change from baseline in physical findings, vital signs, clinical laboratory test results and ECG (glofitamab monotherapy) 5. Serum concentrations of obinutuzumab at specified timepoints 6. Serum concentrations of rituximab at specified timepoints 7. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs against glofitamab during the study;Timepoint(s) of evaluation of this end point: 1-3. Up to approximately 3 years 4. Baseline to 3 years (Until D21 of last cycle for ECG and laboratory parameters) 5. At Days 1, 8, 15 of Cycle 1 6. At Days 1, 5 of Cycle 3 7. At Days 1, 8 of Cycle 1; At Day 5 of Cycle 3, at EOT, and first years follow up | — |
Countries
Australia, China, Denmark, France, Germany, Italy, Korea, Republic of, Spain, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd
Outcome results
None listed