Follicular lymphoma
Conditions
Brief summary
Part 1: Incidence of dose-limiting toxicities (DLTs) for odronextamab, Part 1: Incidence of treatment-emergent adverse events (TEAEs) of odronextamab, Part 1: Severity of TEAEs of odronextamab, Part 2: CR30 as assessed by independent central review
Detailed description
Part 1: Concentrations of odronextamab in serum, Part 1:Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration, Part 1: Magnitude of ADAs to odronextamab over the study duration, Part 1: Objective response as assessed by the investigator, Part 2: Progression-free survival (PFS) as assessed by independent central review, Part 2: Event-free survival (EFS) as assessed by independent central review, Part 2: OS, Part 2: Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)], Part 2: CR30 as assessed by local investigator, Part 2: PFS as assessed by local investigator, Part 2: EFS as assessed by local investigator, Part 2: Objective response assessed by local investigator, Part 2: Objective response assessed by independent central review, Part 2: Duration of response (DOR) assessed by independent central review, Part 2: DOR assessed by local investigator, Part 2: Time to next anti-lymphoma treatment (TTNT), Part 2: Incidence of TEAEs, Part 2: Severity of TEAEs, Part 2: Odronextamab concentrations in serum during the induction period, Part 2: Odronextamab concentrations in serum during the maintenance period, Part 2: Incidence of ADAs to odronextamab over the study duration, Part 2: Magnitude of ADAs to odronextamab over the study duration, Part 2: Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30, Part 2: Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy–Lymphoma (FACT-LymS), Part 2: Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L), Part 2: Change in PGIS and PGIC, Part 2: Change in score of GP5 item in the participant population
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Incidence of dose-limiting toxicities (DLTs) for odronextamab, Part 1: Incidence of treatment-emergent adverse events (TEAEs) of odronextamab, Part 1: Severity of TEAEs of odronextamab, Part 2: CR30 as assessed by independent central review | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Concentrations of odronextamab in serum, Part 1:Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration, Part 1: Magnitude of ADAs to odronextamab over the study duration, Part 1: Objective response as assessed by the investigator, Part 2: Progression-free survival (PFS) as assessed by independent central review, Part 2: Event-free survival (EFS) as assessed by independent central review, Part 2: OS, Part 2: Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)], Part 2: CR30 as assessed by local investigator, Part 2: PFS as assessed by local investigator, Part 2: EFS as assessed by local investigator, Part 2: Objective response assessed by local investigator, Part 2: Objective response assessed by independent central review, Part 2: Duration of response (DOR) assessed by independent central review, Part 2: DOR assessed by local investigator, Part 2: Ti | — |
Countries
Austria, Belgium, Czechia, France, Germany, Italy, Poland, Spain