A Phase II Study of Ibrutinib plus Rituximab in Patients with Previously Untreated Follicular Lymphoma

Protocol
14-018
Full Title
A Multicenter, Open-label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Rituximab in Previously Untreated Subjects with Follicular Lymphoma
Phase
II
Purpose

Ibrutinib is used to treat a form of lymphoma called mantle cell lymphoma which has returned despite prior therapy, but its use in patients with previously untreated follicular lymphoma is considered investigational. It works by blocking a protein inside the lymphoma cells called Bruton’s tyrosine kinase (BTK), which helps the lymphoma cells to live and grow. Rituximab is a standard therapy for treating follicular lymphoma. It works by targeting a protein on lymphoma cells called CD20.

In this study, researchers are assessing the safety and effectiveness of giving both ibrutinib and rituximab to patients with follicular lymphoma who have not yet received treatment for this cancer. They hope that this combination will be more effective than rituximab alone. Ibrutinib is a capsule that is taken orally (by mouth), while 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 stage II, III, or IV follicular lymphoma.
  • Patients may not have previously received treatment for their lymphoma.
  • Patients must be able to be 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. M. Lia Palomba at 212-639-7186.

Disease(s)
Lymphoma: Non-Hodgkin's Lymphoma
Locations
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