This trial is looking to assess the effectiveness of ME-401 for relapsed follicular lymphoma (FL) after the failure of two or more therapies. The main outcome to be measured in this trial is the percentage of patients whose cancer shrinks or disappears after treatment.
The details
FL is a type of non-Hodgkin lymphoma. It affects white blood cells called B-lymphocytes. These cells normally fight infection in the body. It is a common slow-growing cancer. FL that has relapsed or not responded after two or more treatments is difficult to treat.
ME-401 is a new drug that targets and blocks a pathway called PI3Kδ. This leads to the blocking of cancerous cell growth. This trial is assessing whether ME-401 will be effective in treating relapsing FL after two prior therapies have failed.
Who are they looking for?
This trial is looking to recruit 120 patients with relapsing FL. Patients will be included in this trial if they have a confirmed diagnosis of FL, have had progression of their cancer despite treatment to 2 therapies for FL, and if they have adequate blood cell counts, kidney, liver, and heart function.
Patients will be excluded if their FL is grade 3B or has transformed into an aggressive type of lymphoma, or has spread to the brain or spine. Patients with other uncontrolled significant illness, or a history of significant heart or vascular, digestive tract or lung conditions, HIV also cannot participate.
How will it work
There is one group in this trial. All patients will receive 60mg of ME-401 tablets once daily on an intermittent schedule.
The outcomes to be measured in this trial will include the response to the drug, the overall survival of patients, the length of time for patients to have stable disease, and the occurrence of serious side effects caused by the disease. This will be measured over a time-frame of 2-years.
