| Abschnitt | Beschreibung |
|---|---|
| Titel | A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| Protokoll IDs | Protokoll Code: CLLRR1 EUCT: 2024-517131-52-00 |
| Teilnehmende Länder | Europa, Asien, Ozeanien, Amerika |
Status | Rekrutierend(bisher noch nicht in Europa) |
| Ansprechpartner | cll-studie@uk-koeln.de |
| Design | – Prospective
– 4 arms – Randomized (2:2:1:2) and stratified – Open-label – Phase-III |
| Studienziel | Beurteilung der Wirksamkeit der Kombinationstherapie |
| Primärer Endpunkt | Progression-free survival (PFS) |
| Sekundäre Endpunkte | – Undetectable minimal residual disease (uMRD4) rate in peripheral blood at C14D1 – Complete response rate (CRR) – Overall survival (OS) |
| Studienpopulation | Adult patients with a confirmed diagnosis of CLL/SLL, per the iwCLL 2018 criteria and ≥ 1 prior therapy for CLL/SLL |
| Therapie / Therapiearme | – Sonrotoclax and Obinutuzumab – Sonrotoclax and Rituximab – Sonrotoclax plus Obinutuzumab with MRD guided therapy – Venetoclax and Rituximab |
| Erforderliche Patientenzahl | 630 Patienten |
| Sponsor | BeiGene Ltd. |
| Studienleitung | Othman Al-Sawaf (Klinik I für Innere Medizin, Uniklinik Köln) |
