GO42909 - Mosunetuzumab/ Rituximab combined Lenalidomide for FL

• Research type

  Research Study

• Full title

  PHASE III RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF MOSUNETUZUMAB IN COMBINATION WITH LENALIDOMIDE IN COMPARISON TO RITUXIMAB IN COMBINATION WITH LENALIDOMIDE IN PATIENTS WITH FOLLICULAR LYMPHOMA AFTER AT LEAST ONE LINE OF SYSTEMIC THERAPY

• IRAS ID

  1004220

• Contact name

  Micaela Rocco

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffman-La Roche Ltd.

• Eudract number

  2020-005239-53

• Research summary

  The purpose of this study is to compare the effects, good or bad, of mosunetuzumab administered in combination with lenalidomide versus rituximab administered in combination with lenalidomide in patients with R/R FL. In this study, patients will get either mosunetuzumab administered in combination with lenalidomide or rituximab administered in combination with lenalidomide.

  Follicular lymphoma remains an incurable disease with currently available therapies. Despite significant therapeutic progress with the use of immunochemotherapy as the first-line treatment, most patients will eventually relapse. Relapses are characterized by increasing refractoriness and decreasing duration of response to subsequent lines of therapy. the combination of mosunetuzumabwith lenalidomide (M Len) may offer a favorable overall benefit-risk profile and a chemotherapy-free treatment regimen with a novel mechanism of action that will be an important new treatment option for patients with previously treated FL.

  Participants in this trial will be randomised between 2 groups (Group A and Group B).

  This study will enroll approximately 400 patients with FL who were treated with at least 1 prior systemic therapy, across all sites in a global enrollment phase of this study. After completion of the global enrollment phase, additional patients may be enrolled at China’s National Medical Products Administration (NMPA)-recognized sites in an extended China enrollment phase to ensure a total of approximately 60 patients with FL in a China. Approximately 40 participants will take part in the study in the UK subpopulation.

  The study is sponsored by F. Hoffman La Roche

  Research Summary; Version 1 and 13-Sep-2021

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  21/WM/0243

• Date of REC Opinion

  29 Nov 2021

• REC opinion

  Further Information Favourable Opinion