Groupe d'Etude en Oncologie du Quebec

Titre	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
Protocole ID	InMIND (INCMOR 0208-301)
ClinicalTrials.gov ID	NCT04680052
Type(s) de cancer	Lymphome non-hodgkinien (LNH)
Phase	Phase III
Stade	Lymphome folliculaire/zone marginale
Type étude	Clinique
Médicament	Tafasitamab + Lénalidomide et Rituximab comparé à placebo + Lénalidomide et Rituximab
Institution	CHU DE QUEBEC – UNIVERSITE LAVAL HOPITAL DE L'ENFANT-JESUS 1401 18e Rue, Québec, QC, G1J 1Z4
Ville	Québec
Investigateur(trice) principal(e)	Dr Jean-François Larouche
Coordonnateur(trice)	Philippe Nadeau 418-649-0252 poste 63115
Statut	Fermé
Critètes d'éligibilité	Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL Willingness to avoid pregnancy or fathering children In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin) Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy Documented relapsed, refractory, or PD after treatment with systemic therapy ECOG performance status of 0 to 2
Critètes d'exclusion	Women who are pregnant or breastfeeding. Any histology other than FL and MZL or clinical evidence of transformed lymphoma Prior non-hematologic malignancy Congestive heart failure HCV positivity, chronic HBV infection or history of HIV infection Active systemic infection CNS lymphoma involvement Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1 Prior use of lenalidomide in combination with rituximab

Groupe d'étude en oncologie du Québec