Patologia: Linfomi, Neoplasie ematologiche
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: III
Linee di trattamento: Seconda linea, Terza/N linea
Criteri di inclusione:
- Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
- Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
- Relapsed or refractory disease after the last line of therapy
- Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Adequate organ function.
Criteri di esclusione:
- Prior therapy with B-cell lymphoma-2 inhibitor
- Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi
- Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
- Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
- Known central nervous system involvement by lymphoma
- Clinically significant cardiovascular disease
- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trattamento sperimentale:
Sonrotoclax (BGB-11417) + Zanubrutinib (BGB-3111)
Trattamento di controllo:
Zanubrutinib (BGB-3111)
Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
NB: Arruolamento pazienti non ancora attivo
Riferimento: Prof. Pierluigi Zinzani
Email: pierluigi.zinzani@unibo.it
IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC
NB: Arruolamento pazienti non ancora attivo
Telefono: 0543739100
Azienda Sanitaria Universitaria giuliano Isontina
Via Giacomo Puccini 50 - 34148 Trieste - TS
Piazza dell'Ospitale 1- NB: Arruolamento pazienti non ancora attivo
Email: ematologia-clinica@asugi.sanita.fvg.it
AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR
Policlinico G.B. Rossi - Centro Ricerche Cliniche
Email: ematologia@aovr.veneto.it
Presidio Ospedaliero Vito Fazzi Asl Lecce
Piazzetta F. Muratore - 73100 Lecce - LE
Ematologia - NB: Arruolamento pazienti non ancora attivo
Telefono: 0832661926
Email: ematologia.polecce@asl.lecce.it
Numero di iscrizione a registro: 2024-515593-27-00
Data di inserimento: 13.06.2025
BeiGene
Riferimento: Dr. Info non applicabile
Telefono: 00000
Email: na@na.it
Localita: na