Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Conditions
Brief summary
1. Incidence of CRS: Grade 2 or higher CRS at any time during the study, determined according to the ASTCT CRS grading criteria, 2. Incidence of CRS: Any Grade CRS, at any time during the study
Detailed description
1. Incidence of serious CRS events, with severity determined according to the ASTCT CRS grading criteria, 2. CRS frequency relative to the start of the infusion of each of the step-up doses of glofitamab, 3. CRS management, including outcome of patients who experienced a CRS event, 4. Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0, 5. Tolerability, as assessed by dose interruptions, dose reductions, and dose intensity, 6. Study treatment discontinuation because of adverse events, 7. Complete response (CR) rate, 8. Objective response rate (ORR), 9. Duration of response (DOR), 10. Duration of complete response (DOCR), 11. Progression-free survival (PFS), 12. Overall survival (OS)
Interventions
None listed
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of CRS: Grade 2 or higher CRS at any time during the study, determined according to the ASTCT CRS grading criteria, 2. Incidence of CRS: Any Grade CRS, at any time during the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of serious CRS events, with severity determined according to the ASTCT CRS grading criteria, 2. CRS frequency relative to the start of the infusion of each of the step-up doses of glofitamab, 3. CRS management, including outcome of patients who experienced a CRS event, 4. Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0, 5. Tolerability, as assessed by dose interruptions, dose reductions, and dose intensity, 6. Study treatment discontinuation because of adverse events, 7. Complete response (CR) rate, 8. Objective response rate (ORR), 9. Duration of response (DOR), 10. Duration of complete response (DOCR), 11. Progression-free survival (PFS), 12. Overall survival (OS) | — |
Countries
France, Germany, Italy
Outcome results
None listed