A Phase III Study of Bendamustine and Rituximab with or without Ibrutinib in Older Patients with Newly Diagnosed Mantle Cell Lymphoma

Protocol
13-196
Full Title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma
Phase
III
Purpose

Mantle cell lymphoma (MCL) is a type of non-Hodgkin lymphoma (NHL) that can be challenging to treat. Many of the current treatments for MCL cannot be tolerated by older patients. Bendamustine and rituximab are drugs that have been shown to be effective against MCL with fewer side effects than another therapy called R-CHOP. Bendamustine/rituximab has not been approved by the U.S. Food and Drug Administration for treating newly diagnosed MCL, but they are used together in many countries to treat these patients.

Ibrutinib (PCI-32765) is a drug approved for treating MCL that has not responded to treatment or has returned after treatment, but its use in newly diagnosed patients is considered investigational. It works by blocking a protein inside the lymphoma cells called Bruton¿s tyrosine kinase, which helps the lymphoma cells to live and grow.

In this study, researchers are evaluating the effectiveness of bendamustine/rituximab with ibrutinib in patients newly diagnosed with MCL who are age 65 or older. Patients will be randomly assigned to receive either bendamustine/rituximab with ibrutinib, or bendamustine/rituximab with a placebo. Ibrutinib is a capsule that is taken orally (by mouth), while 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 be newly diagnosed with stage II-IV MCL and may not have previously received therapy for this cancer.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 65 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Paul A. Hamlin at 212-639-6143.

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