A Phase IB Study of Ibrutinib with Rituximab and Lenalidomide for Patients with Recurrent or Persistent Primary or Secondary Central Nervous System Lymphoma

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Full Title

Phase Ib Trial with Dose Expansion of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Rituximab and Lenalidomide in Patients with Refractory/Recurrent Primary Central Nervous System Lymphoma (PCNSL) and Refractory/Recurrent Secondary Central Nervous System Lymphoma (SCNSL)

Purpose

The purpose of this study is to determine whether it is safe and effective to give a combination of ibrutinib, rituximab, and lenalidomide to patients with primary central nervous system lymphoma (PCNSL) and secondary CNSL (SCNSL) that has come back or continues to grow despite treatment. Rituximab has been used to treat recurrent and persistent PCNSL. Researchers think that adding ibrutinib and lenalidomide to rituximab could improve the response to treatment and keep the cancer from coming back for a longer period of time. Although each of the drugs is approved for the treatment of recurrent and refractory PCNSL, their use in combination in this study is considered investigational.

Patients in this study will receive increasing doses of ibrutinib and lenalidomide along with a standard dose of rituximab. Ibrutinib and lenalidomide are taken orally (by mouth) and rituximab 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 PCNSL or SCNSL that continues to grow or came back despite at least one prior regimen of therapy directed to the central nervous system (brain/spinal cord).
  • Patients must recover from the serious side effects of prior treatments 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

18-432

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators