Send yourself the details of this trial and next steps
Please provide a valid email address.
Send yourself the details of this trial and next steps
Please provide a valid email address.
This doesn't look like a valid phone number. Please check.
Both First Name and Last Name are required. Please check.
Home»Non-Hodgkin lymphoma» Searching for patients with relapsed/refractory mantle cell lymphoma or newly diagnosed elderly patients to test the effectiveness of ibrutinib with rituximab
Clinical Trial
Searching for patients with relapsed/refractory mantle cell lymphoma or newly diagnosed elderly patients to test the effectiveness of ibrutinib with rituximab
This phase 2 clinical trial will test the effectiveness of an ibrutinib (Imbruvica) and rituximab (Rituxan) combination in treating patients with relapsed or refractory mantle cell lymphoma (MCL) or newly diagnosed elderly patients. The primary objective will be measured by the response rate. This trial is being conducted at the University of Texas MD Anderson Cancer Center.
The details
Ibrutinibis a treatment that stops the growth of B-cells and spread of mantle cell lymphoma. It permanently binds to the Bruton's tyrosine kinase (BTK), a protein essential for B-cell growth and development. BTKs are often overexpressed in mantle cell lymphoma, which leads to uncontrolled B-cell growth. Rituximab is an immunotherapy that uses the body’s own immune system to identify and kill cancerous B-cells. It is an antibody (a protein in the immune system) that binds to a protein found on B-cells, which alerts other parts of the immune system to attack.
The study will examine the response rate to the ibrutinib/rituximab treatment for an 8 week period.
Who are they looking for?
This trial is recruiting 100 patients with relapsed or refractory mantle cell lymphoma (MCL) or newly diagnosed elderly patients (65 or over). Patients must be CD20 and cyclin D1 positive. Participants should not have any disease significantly affecting the gastrointestinal system (GI), significant cardiovascular disease, or history of brain hemorrhage or stroke within 6 months of enrollment.
Patients should be disease free of other malignancies for at least 6 months. Participants should not have undergone surgery or received a live virus vaccine within 4 weeks of enrollment. Ideal candidates should not have received chemotherapy, radiotherapy, other investigational drugs within 3 weeks of enrollment, nitrosoureas within 6 weeks of enrollment, or anticancer antibodies within 4 weeks of entry.
How will it work
Patients will be administered ibrutinibby mouth daily over a 28-day cycle. Rituximab will be given intravenously (through IV) on days 1, 8, 15 of cycle 1, then on day 1 of cycles 3-8. Following cycle 8, rituximabwill be administered on day 1 of every other cycle for up to 2 years. After 2 years, patients will continue to take ibrutinib until there is evidence of disease progression or unacceptable toxicity.
