At Rush University Medical Center, we are putting your safety first. For information about COVID-19, see the latest updates. Rush accepts donations to support our response effort, staff, and patients and families.

Excellence is just the beginning.

Translate

French German Italian Portuguese Russian

Drug Treatment Study for Patients with Follicular Lymphoma

Clinical Trial Title: 
Study of ME-401 in subjects with follicular lymphoma after failure of two or more prior therapies.
Clinical Trial Protocol ID: 
18091301
Clinical Trial Investigator Name: 
Seo-Hyun Kim, MD
Clinical Trial Protocol Description: 

Follicular lymphoma (FL) is a cancer of lymphocytes, a type of white blood cell. The natural history of FL is characterized by multiple relapses. Progression-free survival (PFS) decreases after each line of treatment to less than a year after the fourth line of treatment.

ME-401 is an oral inhibitor of the delta isoform of PI3K with potential anti-cancer activity. This PI3K-delta inhibitor selectively inhibits the delta isoform of PI3K and prevents the activation of the PI3K/AKT signaling pathway. This both decreases cell growth and induces cell death in PI3K-delta-overexpressing cancer cells.

The main purpose of this study is to learn how well ME-401 works on controlling FL, to learn about the safety of the drug, and to compare the safety of 2 different schedules of administration. Patients being asked to take part in this study have been diagnosed with follicular lymphoma that has progressed after at least 2 prior systemic therapies.

The study is composed of 2 treatment groups, Group A and Group B; the difference between them is the schedule of when ME-401 is taken. Subjects are assigned to Group A or Group B by randomization, that is by chance, like the toss of a coin. The study doctor, study site staff, and the participating subject will not know if they are assigned to Group A or Group B.

All subjects receive one capsule of ME-401 at 60 milligrams taken once a day for 2 cycles of 28 days each, for a total of 56 days. After that period, subjects in Group A and Group B will have differing schedules of study drug.

Participating subjects may be in this study for about 2 years. Their participation in the study could be shorter or longer based on how well their lymphoma responds to ME-401 and how they tolerate treatment with ME-401.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are 18 years of age or older and have a confirmed diagnosis of FL.
  • Have disease that has progressed after at least 2 previous treatment regimens.
  • Have adequate organ function.

You will be excluded from the study if any of the following criteria apply to you:

  • Have had major surgery within 4 weeks of Day 1 treatment.
  • Have any uncontrolled clinically significant illness such as active infection, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction.
  • Have a history of clinically significant cardiovascular abnormalities or gastrointestinal (GI) conditions.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Blood Disorders and Hematologic Cancers
Contact Email: 
Contact Phone: 
(312) CANCER-1
Contact Name: 
Rush Cancer Center Clinical Trials Office