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Brief Title: Treatment by a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy
Official Title: A Phase II Trial Evaluating Glofitamab, a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy
Study ID: NCT04703686
Brief Summary: This study is a multicenter phase II trial including 2 cohorts of patients in Refractory/Relapse disease at least 1 month after CAR T-cells therapy: * cohort 1: DLBCL patients * cohort 2: PMBL, mantle cell lymphoma, transformed indolent NHL (t-iNHL) or iNHL CAR T-cells Refractory/Relapse status will be determined by PET-CT central review allowing inclusion in this trial. Patients enrolled will then receive a pre-phase of obinutuzumab followed by experimental treatment:11 cycle of glofitamab. The primary objective of the study is to assess the anti-lymphoma activity of glofitamab, a bispecific CD3xCD20 monoclonal antibody in patients with relapse/refractory DLBCL (cohort 1) disease after anti-CD19 CAR T-cells therapy
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHU de Clermont Ferrand, Clermont Ferrand, , France
Hopital Henri Mondor, Créteil, , France
CHU de Dijon - Hôpital le Bocage, Dijon, , France
CHRU Lille - Hôpital Claude Huriez, Lille, , France
CHU Montpellier, Montpellier, , France
CHU Nantes, Nantes, , France
Hôpital Saint Louis, Paris, , France
APHP - Hôpital de la Pitiè Salpetrière, Paris, , France
APHP - Hôpital Saint Antoine, Paris, , France
CHU de Bordeaux - Hôpital Haut Leveque, Pessac, , France
CHU Lyon Sud, Pierre Bénite, , France
CHU de Rennes - Hôpital Pontchaillou, Rennes, , France
Centre Henri Becquerel, Rouen, , France
IUCT Oncopole, Toulouse, , France
CHU de Brabois, Vandoeuvre les Nancy, , France
Name: Guillaume Cartron, MD,PhD
Affiliation: Lymphoma Study Association
Role: STUDY_CHAIR
Name: Pierre Sesques, MD
Affiliation: Lymphoma Study Association
Role: STUDY_CHAIR