A Phase I/II Study of Ibrutinib in Patients with Recurrent or Persistent Central Nervous System (CNS) Lymphoma

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Full Title

A Phase I/II trial of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, ibrutinib, in Patients with Newly diagnosed or Refractory/Recurrent Primary Central Nervous System Lymphoma (PCNSL) and Refractory/Recurrent Secondary Central Nervous System Lymphoma (SCNSL)

Purpose

Ibrutinib is a drug approved to treat chronic lymphocytic leukemia and mantle cell lymphoma. It works by blocking a protein inside cancer cells called Bruton’s tyrosine kinase (BTK), which helps cancer cells to live and grow. It is a capsule that is taken orally (by mouth).

Ibrutinib is being assessed for its activity against other cancers. The purpose of this study is to find the highest dose of ibrutinib that can be given safely in patients with central nervous system lymphoma (either primary CNS lymphoma or metastasis to the CNS from lymphoma in the body) that has come back or continues to grow despite prior therapy.

Who Can Join

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

  • Patients must have primary CNS lymphoma or metastasis to the CNS from lymphoma in the body (secondary CNS lymphoma) that has come back or continues to grow despite prior therapy.
  • Patients must recover from the side effects of previous therapies before entering 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. Christian Grommes at 212-639-4058.

Protocol

14-184

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Investigator

ClinicalTrials.gov ID

NCT02315326