A Phase I Study of Bendamustine, Rituximab, Ibrutinib, and Venetoclax in Recurrent or Persistent Mantle Cell Lymphoma

Full Title

Phase I Study of Bendamustine, Rituximab, Ibrutinib, and ABT-199 in Relapsed, Refractory Mantle Cell Lymphoma

Purpose

Bendamustine, rituximab, and ibrutinib are drugs used to treat lymphoma. In this study, researchers are seeking the highest dose of the drug venetoclax that can be given safely in combination with these other three anticancer drugs in patients with mantle cell lymphoma that has come back or continued to grow despite treatment. Venetoclax is used to treat chronic lymphocytic leukemia; its use in this study is considered investigational.

Venetoclax blocks a protein called Bcl-2, a protein that helps cancer cells survive and resist the effects of anticancer treatments. By blocking Bcl-2, venetoclax could kill mantle cell lymphoma cells and/or make them more vulnerable to the effects of other cancer treatments. Venetoclax and ibrutinib are taken orally (by mouth), and bendamustine and rituximab are 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 mantle cell lymphoma that has come back or continued to grow despite at least one prior regimen of therapy.
  • At least 3 weeks must pass between the completion of previous treatment 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 Dr. Anita Kumar at 212-639-2668.

Protocol

17-216

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators