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 (MAHOGANY)
Interventional
Phase 3
BeiGene (Voir sur ClinicalTrials)
mars 2022
juin 2030
19 octobre 2024
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 | 04/09/2024 13:49:27 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Necker-Enfants Malades | 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 | |||||
| Centre Hospitalier Le Mans - 72037 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Chu Montpellier Hopital Saint Eloi - 34295 - Montpellier Cedex - France | Contact (sur clinicalTrials) | ||||
| Chu Nancy Hopital Brabois - 54511 - VandoeuvrelesNancy - France | Contact (sur clinicalTrials) | ||||
| Hopital Larchet Chu Nice - 6200 - Nice - France | Contact (sur clinicalTrials) | ||||
| Hopital Prive Dantony, Departement Dhemathologie - 92160 - Antony - France | Contact (sur clinicalTrials) | ||||
| Icans Institut de Cancerologie Strasbourg Europe - 67033 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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.