162-21 | Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With Indolent Non Hodgkin's Lymphoma - (COASTAL)

Overview

“A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study”

This is an open label, two-arm Phase 3 study in subjects with relapsed or refractory FL or MZL to evaluate efficacy and safety of zandelisib in combination with rituximab compared with standard immunochemotherapy (R-B [rituximab + bendamustine], or R-CHOP [combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone]). The subjects must have relapsed after =1 previous line of therapy.