A Phase I Study of Abexinostat and Ibrutinib to Treat Diffuse Large B-Cell Lymphoma and Mantle Cell Lymphoma

Full Title

Phase I Study of Abexinostat and Ibrutinib in Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma

Purpose

The purpose of this study is to find the highest dose of the investigational drug abexinostat that can be given safely with ibrutinib in patients with diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma that continues to grow despite prior treatment.

Abexinostat blocks a protein called histone deacetylase (HDAC). When HDAC is active, tumors tend to grow, so blocking HDAC could slow tumor growth. Ibrutinib is already approved to treat some types of lymphoma, including recurrent mantle cell lymphoma. It inhibits lymphoma growth by blocking a protein called BTK, which is highly active in lymphoma cells.

Laboratory studies suggest that using these two drugs together could boost their effectiveness and stop the growth of lymphoma. Both drugs are taken by mouth.

Eligibility

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

  • Patients must have ABC-DLBCL or mantle cell lymphoma that continues to grow despite previous treatments.
  • Patients may not have previously received a BTK or HDAC inhibitor.
  • At least 2 weeks must pass between the completion of previous chemotherapy or radiation therapy and entry into the study.
  • 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 about this study and to inquire about eligibility, please contact please contact Dr. Gottfried von Keudell or Ashley Ames, RN, at 646-449-1128 or 212-639-3748.

Protocol

19-080

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators