Cancer

The Coastal Study

A Phase 3, Randomized, Open-Label, Controlled Study of Zandelisib (ME-401) in Combination with Rituximab Versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin’s Lymphoma

Trial overview

Disease

Haematology

Topic

The Coastal Study

Sponsor

Description

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

Study details

For detailed information on this trial, please click here

Trial status

Recruiting

Location

Principle Investigator

Dr Graham Collins

MBBS, MA, MRCP, FRCPath, DPhil

Haematology Consultant

Oxford