Groupe d'Etude en Oncologie du Quebec

Title	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
Cancer Type(s)	Non-Hodgkin's Lymphoma
Phase	Phase III
Stage	Indolent Lymphoma
Study Type	Clinical
Drug	Tafasitamab + Lénalidomide et Rituximab comparé à placebo + Lénalidomide et Rituximab
Institution	CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX 5415 boul. de l'Assomption, Montréal, QC, H1T2M4
City
Principal Investigator	Dr. Isabelle Fleury
Coordinator	Nawel Mechtouf 514-252-3400 poste 4681
Status	Recruiting
Activation Date
Eligibility Criteria	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
Exclusion Criteria	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