A Phase I Study of ME-401 in Patients with Recurrent or Persistent Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia or Follicular Lymphoma

Full Title

ME-401-002: A Phase 1b, Open-Label, Dose Escalation Study of ME-401 in Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Follicular Lymphoma (FL)

Purpose

ME-401 is an investigational drug that works by inhibiting PI3K delta, a protein that plays a critical role in the growth of certain blood cancer cells. In this study, researchers are seeking the best dose of ME-401 to give to patients with chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) or follicular lymphoma that has come back or continued growing despite prior therapy. 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 CLL/SLL or follicular lymphoma that has come back or continued growing despite prior therapy.
  • Patients may not have previously received treatments that target PI3K delta or BTK, or they must have been unable to tolerate BTK inhibitors.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • 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

16-1614

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Zelenetz, Andrew, MD, PhD