A PHASE 3 RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER TRIAL 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 (FL) GRADE 1-3A OR R/R MARGINAL ZONE LYMPHOMA (MZL)

Brief description of study

The purpose of the study is to determine and investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL) Grade 1 to 3a or relapsed/refractory marginal zone lymphoma (R/R MZL). While in this study you will be asked to present to the study clinic to have some tests performed, to receive the study treatment and to be monitored. The study drug tafasitamab is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s20-01651
ClinicalTrials.gov Identifier: NCT04680052


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