The COASTAL Study
Research type
Research Study
Full 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
IRAS ID
1003558
Contact name
Igor Gorbatchevsky
Sponsor organisation
MEI Pharma, Inc.
Eudract number
2020-004199-16
Clinicaltrials.gov Identifier
Research summary
Indolent B-cell lymphomas (NHLs), including follicular lymphoma (FL) and marginal zone lymphoma (MZL), generally have a good prognosis and survival rates longer than 10 years, but are not curable with current treatments, especially for those with advanced stages at diagnosis. While FL&MZL initially respond to treatment, patients often go through cycles of remission and relapse. Although most relapses can be successfully treated, the quality and duration of remissions decreases over time. Finally, these lymphomas become unresponsive to treatment or transform into an aggressive disease with poor prognosis.
The most common treatment options for previously untreated FL&MZL include immunotherapy alone (e.g. rituximab), and immunochemotherapy combinations (e.g. rituximab+CHOP or rituximab+bendamustine). Response outcome varies based on duration of prior response, disease and patient-related factors; however, disease will inevitably relapse. New active treatments with different mechanisms of action are needed for patients with relapsed disease. Furthermore, since the average age of patients with FL&MZL at relapse is over 60, new treatment options must be well-tolerated and avoid common chemotherapy toxicities.
Zandelisib is a PI3K inhibitor. PI3K inhibitors can disrupt growth and replication of cancer cells but are often limited by drug-class associated toxicities. Studies of zandelisib (monotherapy and in combination with rituximab) have found it to be effective and to have a lower incidence of adverse events when taken on an intermittent schedule.
The purpose of this study is to determine if zandelisib in combination with rituximab is a more effective treatment than rituximab+CHOP or rituximab+bendamustine. This study will also assess study treatment safety and tolerability.
Approximately 534 adult patients with FL/MZL will participate in this study at about 190 study sites in 23 countries. Participation in this study is estimated to last up to at least 5 years.REC name
West of Scotland REC 1
REC reference
21/WS/0036
Date of REC Opinion
7 May 2021
REC opinion
Further Information Favourable Opinion