ME-401-003

A Multicenter, Open Label Single-Arm, Phase 2 Study of ME-401 in Subjects With Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies

Study treatments

Subjects with relapsed/refractory FL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS). 

Inclusion criteria

• Histologically confirmed diagnosis of follicular lymphoma (FL) as defined in the World Health Organization (WHO) classification scheme, limited to Grade 1, 2, or 3a
• Subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for FL
• Age ≥ 18
• At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by computed tomography (CT) scan as defined by the Lugano Classification

Exclusion criteria

• Histologically confirmed FL Grade 3b transformation from FL to an aggressive lymphoma
• Known lymphomatous involvement of the central nervous system

Participating sites

• Cliniques Universitaires Saint-Luc