A Phase IB/II study of Copanlisib plus Ibrutinib for Patients with Recurrent or Persistent Primary Central Nervous System Lymphoma

Full Title

Phase IB/II Study Combining the PI3K Inhibitor Copanlisib with the BTK Inhibitor Ibrutinib in Patients with Recurrent/Refractory Primary CNS Lymphoma

Purpose

In this study, researchers are determining the highest doses of ibrutinib and copanlisib that can be given together safely in patients with primary central nervous system lymphoma (PCNSL) that has come back or continued to grow despite prior therapy, and to assess the effectiveness of this combination treatment. Copanlisib works by targeting an enzyme called PI3K, which drives cancer growth. Ibrutinib blocks a protein inside cancer cells called Bruton’s tyrosine kinase (BTK), which helps cancer cells to live and grow.

Copanlisib is used to treat follicular lymphoma, and ibrutinib is used for several other types of lymphoma. Their use together in this study is considered investigational. Copanlisib is given intravenously (by vein), and ibrutinib 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 PCNSL that continues to grow or came back despite prior therapy.
  • Patients may not have previously received a PI3K inhibitor. Prior ibrutinib therapy is permitted.
  • Patients should recover from the serious side effects of prior 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

18-246

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators