Clinical Trial TitleStudy of ibrutinib and rituximab in subjects whose follicular lymphoma has not been treated before.
Clinical Trial Protocol Description:
Follicular lymphoma is one type of non-Hodgkin lymphoma. In follicular lymphoma, the white blood cells grow and survive longer than normal and this can cause problems such as large lymph glands, particularly in the neck, armpit, or groin areas. Some patients with follicular lymphoma develop large tumors in the abdomen.
Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins inside cells that help cells live and grow. The specific kinase inhibited or blocked by ibrutinib is believed to help blood cancer cells live and grow. By inhibiting the activity of this specific kinase, it is possible that the ibrutinib may kill the cancer cells or stop them from growing. Ibrutinib (IMBRUVICA®) has been approved for indications covering the treatment of patients with: 1) mantle cell lymphoma (MCL) in patients who have received at least one prior therapy, 2) patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) including CLL/SLL patients with a 17p deletion or a TP53 mutation, and 3) patients with Waldenstrom’s macroglobulinemia. Ibrutinib has not been approved for follicular lymphoma.
Rituximab is a type of drug called a monoclonal antibody. It is believed that rituximab works by using the body’s immune system to attack the cancer. Rituximab may work by attaching to the cancer cells (lymphocytes) and causing the cells to die or by signaling your immune system to destroy the cancer cells. Rituximab (Rituxan®) is approved for the treatment of follicular lymphoma and other diagnoses. However, the two study medications ibrutinib and rituximab have not been approved for use in combination to treat follicular lymphoma.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have documented grade 1, 2, or 3a CD20+ follicular lymphoma.
- Have measurable disease.
- Are 70 years of age or older, or are 60-69 years of age with one or more disease conditions that make you a candidate to receive single-agent rituximab treatment.
You will be excluded from the study if any of the following criteria apply to you:
- Have transformed lymphoma.
- Have had prior treatment for follicular lymphoma.
- Have a history of stroke or intracranial hemorrhage within 6 months prior to study enrollment.
This is a partial list of inclusion and exclusion criteria.