Etude : MAGNOLIA / BGB-3111-214 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : MAGNOLIA / BGB-3111-214

Nom :

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 17/10/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma

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 : This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in patients with relapsed/refractory marginal zone lymphoma (R/R MZL).

Study arm:
Single Group Assignment-> Drug: Zanubrutinib (BGB-3111) at a dose of 160 mg PO BID


Current primary outcome:
Overall response rate (ORR) determined by independent central review [ Time Frame: Up to 3 years ]

Current secondary outcomes:
- ORR by investigator assessment [ Time Frame: Up to 3 years ]
- Progression-free survival (PFS) [ Time Frame: Up to 3 years ]
- Overall survival (OS) [ Time Frame: Up to 3 years ]
- Duration of response (DOR) [ Time Frame: Up to 3 years ]
- Time to response (TTR) [ Time Frame: Up to 3 years ]
- Patient-reported outcomes (PROs) as measured by the EQ-5D-5L questionnaire [ Time Frame: Up to 3 years ]
- PROs as measured by the EORTC QLQ-C30 questionnaire [ Time Frame: Up to 3 years ]
- Occurrence and severity of treatment-emergent adverse events (safety and tolerability) [ Time Frame: Up to 3 years ]

Phase : II

Stade : NA

NA
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 : - Age 18 years or older
- Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes
- Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least PR or documented PD after, the most recent systemic treatment
- Current need for systemic therapy for MZL
- Measurable disease by CT or MRI
- ECOG of 0-2
- Life expectancy ≥ 6 months
- Adequate bone marrow function
- Adequate organ function
- Male and female patients must use highly effective methods of contraception

Critères de non-inclusion : - Known transformation to aggressive lymphoma, eg, large cell lymphoma.
- Clinically significant cardiovascular disease
- Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer
- History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
- History of stroke or intracranial hemorrhage
- Severe or debilitating pulmonary disease
- Active fungal, bacterial and/or viral infection requiring systemic therapy
- Known central nervous system involvement by lymphoma
- Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection
- Major surgery within 4 weeks of the first dose of study drug
- Prior treatment with a BTK inhibitor
- Pregnant or lactating women
- Requires ongoing treatment with a strong CYP3A inhibitor or inducer
- Concurrent participation in another therapeutic clinical trial
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03846427
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 de Dunkerque - 130, avenue Louis Herbeaux - CS 76367 - 59140 DUNKERQUE

Investigateur :
Docteur Jean-Michel PIGNON

TEC / ARC / IDE :
Virginie EL AZOUZI - PAQUEZ
Virginie.Paquez@
ch-dunkerque.fr
03 28 28 59 00 poste 6485

Ouverture de l'essai : OUVERT

MAJ : 17/10/2019