Project Title

Phase 3 Study of Zandelisib (ME-401) in combination with rituximab in patients with iNHL - (COASTAL)

Official Title

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

Project Summary

This is an open label, randomized, two-arm Phase 3 study in subjects with relapsed or refractory FL and MZL to evaluate efficacy and safety of zandelisib in combination with rituximab in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP).

Subjects must have relapsed after at least one previous line of systemic immunochemotherapy. Previous treatments must have included an anti-CD20 monoclonal antibody (mAb) with chemotherapy such as Bendamustine (B), CHOP, CVP, FND, or similar regimens, or an anti-CD20 mAb with Lenalidomide (L).

Approximately 534 randomized subjects will be enrolled in this study.

Blood Disorder

• Indolent Non-Hodgkin’s Lymphoma – Follicular Lymphoma or Margina Zone Lymphoma

Patient Recruitment Details

Patient recruitment status: closed

Number of patients (Globally)

Undetermined