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
BeOne Medicines (Voir sur ClinicalTrials)
mars 2022
juin 2030
11 juin 2026
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.