A Phase II Study of ME-401 in People with Recurrent or Persistent Follicular Lymphoma

Share
Print

Full Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Phase 2 Study of ME-401 in Subjects with Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies

Purpose

The purpose of this study is to see if the investigational drug ME-401 is safe and effective for people with follicular lymphoma that has come back or continues to grow despite two or more prior regimens of therapy. ME-401 works by blocking PI3K, a protein that is very active in many types of lymphoma. When PI3K is blocked, cancer cells may die and tumor growth may stop.

Patients will be randomly assigned to take ME-401 every day or to take it intermittently with a placebo (inactive pill). ME-401 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have follicular lymphoma that has come back or continues to grow despite two or more prior regimens of therapy.
  • Patients may not have previously received a PI3K inhibitor.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Andrew Zelenetz at 212-639-2656.

Protocol

19-246

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Zelenetz, Andrew, MD, PhD

Co-Investigators