B-Cell Non-Hodgkin's Lymphoma
Conditions
Brief summary
Event-free survival (EFS) as assessed by independent central review (ICR)
Detailed description
Progression free survival (PFS) as assessed by ICR, Best overall response (BOR) as assessed by ICR, Overall survival (OS), Overall change in physical functioning as measured by scores of the physical function scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30), EFS as assessed by local investigator, PFS as assessed by local investigator, BOR as assessed by local investigator, Complete response (CR) assessed by ICR and local investigator, Duration of response (DOR) assessed by ICR and local investigator, Incidence of treatment-emergent adverse events (TEAEs), Severity of TEAEs, Odronextamab concentrations in serum, Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration, Titers of ADAs to odronextamab over the study duration, Incidence of neutralizing antibodies (NAb) to odronextamab over the study duration, Measurable residual disease (MRD) status, Overall change in patient-reported outcomes (PROs), as measured by scores of the EORTCQLQ- C30, Overall change in PROs, as measured by scores of the Functional Assessment of Cancer Therapy–Lymphoma (FACT-LymS), Overall change in PROs, as measured by scores of the EuroQol-5 Dimension-5 Level Scale (EQ-5D-5L), Overall change in score of the Global Population item 5 (GP5) of the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival (EFS) as assessed by independent central review (ICR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) as assessed by ICR, Best overall response (BOR) as assessed by ICR, Overall survival (OS), Overall change in physical functioning as measured by scores of the physical function scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30), EFS as assessed by local investigator, PFS as assessed by local investigator, BOR as assessed by local investigator, Complete response (CR) assessed by ICR and local investigator, Duration of response (DOR) assessed by ICR and local investigator, Incidence of treatment-emergent adverse events (TEAEs), Severity of TEAEs, Odronextamab concentrations in serum, Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration, Titers of ADAs to odronextamab over the study duration, Incidence of neutralizing antibodies (NAb) to odronextamab over the study duration, Measurable residual disease (MRD) status, Overall change in patient-reported outcomes | — |
Countries
Austria, Belgium, Czechia, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain