Project Title

Study of ME-401 in Subjects With Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Phase II Study of ME-401 in Subjects With Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies.

Project Summary

This is a global, multicenter, randomized, double-blind, placebo-controlled, two arm, Phase II study of the PI3Kδ inhibitor ME-401 in subjects with relapsed/refractory follicular lymphoma after failure of at least two prior lines of systemic therapy which must have included an anti-CD20 antibody and chemotherapy with an alkylating agent or a purine analogue. The study will evaluate the efficacy and safety of ME-401 administered using two different schedules: daily continuously or daily continuously for two cycles then daily for the first 7 days of each subsequent cycle. Approximately 165 subjects will be randomized into the study.

Blood Disorder

• Follicular Lymphoma

Patient Recruitment Details

Patient recruitment status: Open

Number of Patients (Globally)

165 participants.