Trial Number

162-21

Condition

Lymphoma

Participant Age Range

18 years and older

Participant Gender

Any

Enrolling Participants

Yes

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.

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