CORE – Epcoritamab treatment in patients with DLBCL under real world conditions in Germany
Frau Dr. med. Stephanie Herold
stephanie.herold@unimedizin-mainz.de
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Mainz (Prüfzentrum (CAR-T), 11520)
III. Medizinische Klinik und Poliklinik
Langenbeckstr. 1
55131 Mainz
| Beschreibung | In later treatment lines of diffuse large B-cell lymphoma (DLBCL), effective and safe treatment options are urgently needed. Epcoritamab has received a conditional market authorization in the EU in september 2023 based on a pivotal phase II trial after at least two lines of therapy. However, phase III data does not exist and supportive data is required. Study objective is to investigate safety and effectiveness of Epcoritamab monotherapy and compliance to Epcoritamab label recommendations under real-world conditions in Germany thereby closing the real-world evidence gap. | |
| Indikation | DLBCL | |
| Patientenpopulation | 120 patients with DLBCL after at least two prior lines of therapy | |
| Statistische Annahmen | Sample size: Assuming an observed overall response rate (ORR) of 60% (based on the pivotal phase II trial (GCT3013-01 / EPCORE NHL-11) and with the suggested sample size of 120 subjects, the 95% exact CI will have a width of 50.7 to 68.6.
Data will be analyzed descriptively. For categorical / binary variables counts and percentages will be calculated. For continuous variables mean, standard deviation, median, first and third quartile, minimum, and maximum will be calculated. In addition, for primary and secondary endpoints, 95% confidence intervals for proportions and means will be calculated (if applicable). All data will be analyzed as observed in this non-interventional study, i.e. no imputation of missing data will be performed. For identification of predictors of response, adequate statistical models (logistic regression, analysis of covariance), controlling for potential confounders will be used. Further details regarding the statistical models will be described in the study protocol and the statistical analysis plan. 1Thieblemont et al. Leukemia. 2024 Dec | |
| Primäre Endpunkte | Overall response rate (ORR) (defined as proportion of patients who achieved best overall response of complete response (CR) or partial response (PR)) according to physician’s assessment = 63.1% (N = 99/157; 95% CI, 55.0–70.6) | |
| Sekundäre Endpunkte | • Complete response (CR) rate (defined as proportion of patients with CR) according to physician’s assessment (continuously documented by cycle)
• Partial response (PR) rate (defined as proportion of patients with PR) according to physician’s assessment (continuously documented by cycle) • Duration of response (DoR) and duration of complete response (DoCR) (defined as the time from the first documentation of response / CR to the date of PD or death, whichever occurs earlier) • Time to next treatment (TTNT) (defined as the time from Day 1 of Cycle 1 to first recorded administration of subsequent anti-lymphoma therapy or death due to any cause, whichever occurs earlier.) • Overall survival (OS) (defined as the time from Day 1 of Cycle 1 to death) (continuously documented) • Progression-free survival (PFS) (defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier) (continuously documented) • AE (including CRS) and SAE (continuously documented by cycle) • Dose modification of Epcoritamab (continuously documented by cycle) • Compliance with Epcoritamab step-up dosing and premedication for CRS prophylaxis in cycle 1 (as defined in label recommendations of Epcoritamab) • Use of measures related to management of CRS (CRS-related hospitalization, supplemental oxygen, use of vasopressors, tocilizumab or other anticytokine agents, corticosteroids) (continuously documented by cycle) • Interruption or discontinuation of Epcoritamab treatment for any reason (including rationale) (continuously documented by cycle) • Further course of treatment after discontinuation of Epcoritamab | |
| Geplante Projektdauer (Projektstart, Projektende) | 5 years (3 years recruitment of Epcoritamab patients within GLA and 2 years follow-up)
project start Q2/2025 project end Q2/2030 | |
| Projekt finanziert durch | AbbVie | |
| Geschätzte Kosten | none for GLA | |
| 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 | |
