A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Studientyp
Interventional
(ICTRP)
Untersuchte Intervention
Drug: ZanubrutinibDrug: RituximabDrug: LenalidomideDrug: Obinutuzumab
(ICTRP)
Untersuchte Krankheit(en)
Relapsed/Refractory Follicular LymphomaMarginal Zone Lymphoma
(ICTRP)
Key Inclusion Criteria:
- Histologically confirmed grade 1-3a FL or MZL
- Previously treated with >= 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy
- Need for systemic therapy for FL or MZL
- Measurable disease by computed tomography or magnetic resonance imaging
- Adequate bone marrow, liver and renal function
Key Exclusion Criteria:
- Transformation to aggressive lymphoma
- Requiring ongoing need for corticosteroid treatment
- Clinically significant cardiovascular disease
- Prior malignancy within the past 2 years
- Active fungal, bacterial, and/or viral infection that requires systemic therapy
- Prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (< 24 months)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
(ICTRP)
Ausschlusskriterien
nicht verfügbar
Studienstandort
Vereinigte Staaten, Argentinien, Australien, Österreich, Belgien, Brasilien, Bulgarien, Kanada, China, , Frankreich, Georgien, Deutschland, Griechenland, Irland, Israel, Italien, Japan, Polen, Portugal, , Rumänien, Südafrika, , Spanien, Schweiz, , Vereinigtes Königreich, Niederlande
(ICTRP)
Allgemeine Auskünfte
BeOne MedicinesBeOne Medicines
1-877-828-5568
clinicaltrials@beonemed.com(ICTRP)
Allgemeine Auskünfte
BeOne MedicinesBeOne Medicines
(ICTRP)
Wissenschaftlicher Titel
A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
(ICTRP)
Primäre und sekundäre Endpunkte
Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)
(ICTRP)
Progression-free Survival As Determined By Investigator Assessment;Duration Of Response As Determined By BIRC And By Investigator Assessment;Overall Response Rate As Determined By BIRC And By Investigator Assessment;Complete Response Rate As Determined By BIRC And By Investigator Assessment;Time To Response As Determined By BIRC And By Investigator Assessment;Time to Next Ant-Lymphoma Treatment;Overall Survival;Health-related Quality Of Life (HRQoL) Using EORTC QLQ-C30);HRQoL Using European Quality of Life 5 Dimension 5 Level Questionnaire [EQ 5D 5L);HRQoL Using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 [FLymSI 18);Number of Participants Experiencing Adverse Events (AEs)
(ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Study Director;Study Director;Study Director BeiGene, clinicaltrials@beigene.com, 1-877-828-5568, BeiGene,BeiGene, (ICTRP)
Sekundäre IDs
CTR20232545, 2022-502548-12-00, BGB-3111-308 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT05100862 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar