Real-world Outcome analysis of Odronextamab for relapsed/refractory large B-cell lymphoma and follicular lymphoma (OdroRA)
Herr Dr. med. Konstantinos Christofyllakis
Konstantinos.Christofyllakis@uks.eu
Universität des Saarlandes - Homburg (Institution, 12033)
Klinik für Innere Medizin I
Geb. 41.1, Kirrberger Str. 100
66421 Homburg
| Beschreibung | Multicenter, retrospective/prospective observational cohort (non interventional) within the German Lymphoma Alliance | |
| Indikation | DLBCL, follikuläres Lymphom | |
| Patientenpopulation | r/r LBCL and r/r FL | |
| Statistische Annahmen | Total Number of Subjects Expected to Be Enrolled: 60 Total
(30 LBCL, 30 FL) Primary endpoint precision (BOR): Overall cohort (n≈60): if true BOR ≈50%, 95% CI ≈ ±13%. LBCL stratum (n≈40): if true BOR 40–50%, 95% CI ≈ ±15%. FL stratum (n≈20) if true BOR 40–50%, 95% CI ≈ ±21%. | |
| Primäre Endpunkte | The primary efficacy endpoint is the BORR defined as the proportion of a complete or partial remission as best response at any time following treatment initiation with odronextamab according to the 2014 Lugano criteria, as assessed by local investigator review. The endpoint will be assessed for patients treated in 3L, 4L+ as standalone therapies and for those treated with odronextamab as an intent to bridge to CAR-T cell therapy separately. | |
| Sekundäre Endpunkte | a. those treated in third line (3L) as a standalone therapy
b. those treated beyond third line (4L+) as a standalone therapy c. and those treated with odronextamab as an intent to bridge to CAR-T cell therapy • Complete response (CR) rate defined as complete remissions as best response divided by the number of patients treated with at least one dose of odronextamab. • Partial response (PR) rate defined as partial remissions as best response divided by the number of patients treated with at least one dose of odronextamab. Response assessment will be done according to the Lugano Classification. • Time to complete response or partial response measured as the time from the start of therapy to documentation of complete or partial remission, respectively. • Time to best response measured as the time from the start of therapy to documentation of the best tumor response according to type of response. • Duration of response measured as the time from documentation of tumor response (complete or partial remission) to relapse or progressive disease. • BORR defined as the best overall response of complete or partial remission after odronexatamab initiation. • Progression rate measured as the number of progressions after initiation of odronextamab. • Relapse rate measured as the number of relapses after initiation of odronextamab. • Outcomes according to biological characteristics of the lymphoma, as assessed by local investigator review • Date of relapse/PD defined by Lugano criteria. In case of obvious clinical progression, the relapse/PD may be defined beyond of Lugano criteria (e.g. clinical assessment, ultrasound and etc.). • Time to relapse/PD from initiation of odronextamab (mo) • CD20 expression (if available) before and after odronextamab • Outcomes of odronextamab as a bridging therapy to CAR - PR rate on odronextamab prior to CAR-Ts - CR rate on odronextamab prior to CAR-Ts - Proportion of patients entering CAR-T cell therapy following odronextamab as a bridge - Date of relapse/PD post-CAR-Ts - Progression/relapse rate post-CAR-Ts - Time to relapse/PD from initiation of odronextamab (mo) - Subsequent therapy after odronextamab and CAR-T cells - Best response to subsequent therapy • Subsequent therapy after odronextamab • Best response to subsequent therapy • Remission status at last follow-up (index date: start of odronextamab; CR, PR, SD, PD) • Survival status at last follow-up (index date: start of odronextamab) • Date of death • Death reason • Progression-free survival (PFS) with a 95% confidence interval. PFS is defined as time from the first dose of odronextamab until one of the following events occurs, whichever is first: - Disease progression - Relapse - Death due to any cause Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment. • Overall survival (OS) defined as the time from the first dose of odronextamab to death of any cause. Patients who have not experienced an event at the time of analysis will be censored at the last date known to be alive. Patients who have not experienced an event at the time of analysis will be censored at the last date known to be alive. | |
| Geplante Projektdauer (Projektstart, Projektende) | Duration of Enrollment 12 months
Estimated study start 04/2026 Estimated FSI 04/2026, with additional retrospective backfill as far as 09/2025 Estimated LPI date 10/2026 Final study report 02/2027 | |
| Projekt finanziert durch | Regeneron | |
| Geschätzte Kosten | tbd | |
| Biometrische Analyse | Datenexport und eigene Analyse | |
| Ist eine Erweiterung des Datensatzes projektspezifisch notwendig? | Nein | |
| Ist eine direkte Interaktion (über die Vertrauenstelle) mit den Patienten geplant? | Nein | |
