Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
BeiGene (Voir sur ClinicalTrials)
mars 2022
juin 2030
02 octobre 2025
The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab
versus lenalidomide plus rituximab (R^2) in participants with relapsed/refractory (R/R)
follicular lymphoma (FL), as measured by progression-free survival as determined by an
independent review committee in accordance with the 2014 modification of the
International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron
emission tomography and computed tomography (PET/CT), and to compare the efficacy of
zanubrutinib plus rituximab versus R^2 in participants with R/R marginal zone lymphoma
(MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with
CT-based Lugano 2014 Criteria.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:11:56 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chu Nancy Hopital Brabois - 54511 - VandoeuvrelesNancy - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- 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.