A Phase II Study of CPI-613 for Patients with Recurrent or Persistent Burkitt Lymphoma/Leukemia or High-Grade B-Cell Lymphoma with High-Risk Genetic Changes

Full Title

A Phase II Clinical Trial of CPI-613 in Patients with Relapsed or Refractory Burkitt’s Lymphoma/Leukemia or high-grade B-cell lymphoma with rearrangements of MYC and BCL2 and/or BCL6

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug CPI-613 in patients with one of two kinds of lymphoma that has come back or continued to grow despite treatment:

  • Burkitt lymphoma/leukemia
  • High-grade B-cell lymphoma that contains genetic changes that indicate the patient has a high risk of continued cancer growth. (in this case, “double or triple hit” lymphomas)

CPI-613 is a chemotherapy drug that kills cancer cells by targeting their mitochondria. Mitochondria are parts of both healthy cells and cancer cells, and their role is to produce energy. Cancer cells are more sensitive than healthy cells to blocking of the energy pathway. CPI-613 works by shutting down the mitochondria in cancer cells, depriving them of the energy they need to survive and grow. CPI-613 is given intravenously (by vein).

Eligibility

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

  • Patients must have Burkitt lymphoma/leukemia or high-grade B-cell lymphoma that has continued to grow or came back despite prior treatment.
  • Patients’ cancers must have mutations in the MYC, BCL2, and/or BCL6 genes.
  • Patients must recover from the serious side effects of previous treatments before entering the study.
  • In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ariela Noy at 212-639-7423.

Protocol

18-443

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators