Etude : BGB-3111-306 /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : BGB-3111-306

Nom :

Traitement : Induction

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 07/07/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C85 - Lymphome non hodgkinien, de types autres et non précisés
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : STUDY ARMS:
- Experimental: zanubrutinib plus rituximab
zanubrutinib = Administered as two 80 mg capsules by mouth twice a day
rituximab = Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6

- Active Comparator: bendamustine plus rituximab
benrituximab = Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
bendamustine = Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6

CURRENT PRIMARY OUTCOME:
Progression-free survival (PFS) determined by independent central review [ Time Frame: Up to 7 years ]

CURRENT SECONDARY OUTCOMES:
- PFS by investigator [ Time Frame: Up to 7 years ]
- Overall response rate (ORR) [ Time Frame: Up to 7 years ]
- Duration of response (DOR) [ Time Frame: Up to 7 years ]
- Overall survival (OS) [ Time Frame: Up to 7 years ]
- Participant-reported outcomes (PROs) as assessed by the EQ-5D-5L questionnaire [ Time Frame: Up to 7 years ]
- PROs as assessed by the EORTC QLQ-C30 questionnaire [ Time Frame: Up to 7 years ]
- Occurrence and severity of treatment-emergent adverse events (safety and tolerability) [ Time Frame: Up to 7 years ]

Phase : III

Stade : NA

1 (hémato)
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : Key Inclusion Criteria:

- ≥ 70 years of age at the time of informed consent, OR 65-69 years of age with comorbidities precluding autologous stem cell transplantation
- Histologically confirmed diagnosis of MCL
- No prior systemic treatments for MCL
- Measurable disease by CT/MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate marrow and organ function

--- Other protocol defined Inclusion/Exclusion criteria may apply ---

Critères de non-inclusion : Key Exclusion Criteria:

- Known central nervous system involvement by lymphoma
- Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
- Clinically significant cardiovascular disease
- History of severe bleeding disorder
- Unable to swallow capsules or disease significantly affecting gastrointestinal function
- Active fungal, bacterial and/or viral infection requiring systemic therapy
- Requires ongoing treatment with a strong CYP3A inhibitor or inducer

--- Other protocol defined Inclusion/Exclusion criteria may apply ---
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04002297
Promoteur :
BeiGene
Type de sponsor : Industriel
-
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Franck MORSCHHAUSER

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Statut de l'essai : OUVERT

MAJ : 07/07/2020