| Abschnitt | Beschreibung |
|---|---|
| Titel | A prospective, open-label, randomized, multicenter phase-III trial to evaluate the efficacy of pirtobrutinib and epcoritamab compared with R-(mini)-CHOP for treatment of patients with Richter Transformation |
| Protokoll IDs | Protokoll Code: CLLRT2 EUCT: 2024-513445-37 |
| Teilnehmende Länder | Australia, Austria, Denmark, Germany, Ireland, Italy, Netherlands, New Zealand |
| Status | Planned |
| Kontakt | CLL-RT2@uk-koeln.de |
| Design | – Prospective – 2 arms – Randomized (1:1) and stratified – Open-label – Phase-III |
| Studienziel | Beurteilung der Wirksamkeit und Sicherheit der Kombinationstherapie |
| Primärer Endpunkt | Investigator-assessed progression-free survival (PFS) according to Lugano criteria (Cheson et al 2007) |
| Sekundäre Endpunkte | – Overall response rate (ORR) at the end of (combination) treat-ment according to Lugano criteria (Cheson et al 2007) – Complete response rate (CRR) at the end of (combination) treatment according to Lugano criteria (Cheson et al 2007) – Duration of response (DOR) according to Lugano criteria (Cheson et al 2007) – Overall survival (OS) – Time to next treatment (TTNT) – Proportion of patients receiving SCT allogeneic stem cell transplantation for consolidation – Safety: type, frequency, and severity of adverse events (AEs), adverse events of special interest (AESI) and adverse events of particular interest (AEPI) |
| Studienpopulation | Adult patients with previously untreated Richter Transformation (RT) |
| Therapie / Therapiearme | – pirtobrutinib and epcoritamab – R-(mini)-CHOP |
| Erforderliche Patientenzahl | 116 |
| Sponsor | Universität zu Köln |
| Leiterin der klinischen Prüfung (LKP) | Prof. Dr. Barbara Eichhorst, Klinik I für Innere Medizin, Uniklinik Köln |
