A Phase II Study of Mocetinostat in Patients with Diffuse Large B-cell Lymphoma or Follicular Lymphoma with Certain Mutations

Full Title

An Open-Label Phase II Study of Mocetinostat in Selected Patients with Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

Purpose

Some patients with lymphoma have genetic mutations that may contribute to their cancer growth. The CREBBP and EP300 genes are frequently mutated in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma. Mocetinostat is an investigational drug designed to preferentially kill lymphoma cells that have these mutations.

The purpose of this study is to assess the safety and effectiveness of mocetinostat in patients with DLBCL and follicular lymphoma who have CREBBP and EP300 mutations and whose cancer has come back or continued to grow despite treatment. Mocetinostat 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 DLBCL or follicular lymphoma with a CREBBP or EP300 mutation.
  • Patients with DLBCL must have had at least two prior therapies and may not be candidates for stem cell transplantation. Patients who have follicular lymphoma must have had at least three prior therapies. Patients who have had only one prior therapy may be able to enroll in the study if they cannot tolerate more chemotherapy.
  • At least 4 weeks must pass between completion of prior treatment and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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. Anas Younes at 212-639-5059 or Amy Copeland at 212-639-6104.

Protocol

14-106

Phase

II

Investigator

Zelenetz, Andrew, MD, PhD

Co-Investigators

Locations