A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Type of trial
Interventional
(ICTRP)
Intervention under investigation
Drug: ZanubrutinibDrug: RituximabDrug: LenalidomideDrug: Obinutuzumab
(ICTRP)
Disease under investigation
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)
Exclusion criteria
not available
Trial sites
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, , France, Georgia, Germany, Greece, Ireland, Israel, Italy, Japan, Poland, Portugal, , Romania, South Africa, , Spain, Switzerland, , United Kingdom, Netherlands
(ICTRP)
General Information
BeOne MedicinesBeOne Medicines
1-877-828-5568
clinicaltrials@beonemed.com(ICTRP)
General Information
BeOne MedicinesBeOne Medicines
(ICTRP)
Academic title
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)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
(ICTRP)
Primary and secondary end points
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)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Study Director;Study Director;Study Director BeiGene, clinicaltrials@beigene.com, 1-877-828-5568, BeiGene,BeiGene, (ICTRP)
Secondary trial IDs
CTR20232545, 2022-502548-12-00, BGB-3111-308 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT05100862 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available