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Home»Non-Hodgkin lymphoma» Looking for patients to test the effectivenss of ibrutinib plus rituximab with chemotherapy in treating mangle cell lymphoma
Clinical Trial
Looking for patients to test the effectivenss of ibrutinib plus rituximab with chemotherapy in treating mangle cell lymphoma
This phase 2 clinical trial will test the effectiveness a combination of ibrutinib(Imbruvica) and rituximab (Rituxan) with hyper-CVAD and MTX-AraC chemotherapy in treating mantle cell lymphoma (a cancer of B-cells). The primary outcome will be measured by overall response and side effects. This trial is taking place at the University of Texas MD Anderson Cancer Center.
The details
Ibrutinib is a drug that stops the growth of B-cells and spread of mantle cell lymphoma. It 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. Hyper-CVAD and MTX-AraC chemotherapies are combinations of multiple drugs.
This trial will measure the response to this combination of treatments over 8 weeks. Side effects due to ibrutinib andrituximaband the time to disease progression will also be followed.
Who are they looking for?
This trial is recruiting 100 patients with mantle cell lymphoma who have not received prior treatment. Patients must have adequate organ function and must be disease free of prior cancers. Men and women of childbearing potential must agree to use a form of contraception. Patients should have adequate blood laboratory values.
Participants cannot have HIV, active hepatitis B or C, or gastrointestinal (GI) disease that significantly affect GI function. Ideal patients should not have an acute infection requiring treatment within 14 days of enrollment.
How will it work
This trial will be divided into 2 parts. During part 1, patients will receive ibrutinib and rituximab throughout a 21-day cycle. Ibrutinib will be taken daily by mouth throughout the cycle. Rituximab will be administered intravenously (through IV into a vein) once a week during the first cycle, then on day 1 during cycles 3-12.
In part 2 of the trial, patients will be administered rituximaband hyper-CVAD alternating every cycle with a rituximab and MTX-AraC treatment. The individual drugs in the combination chemotherapies will be given intravenously or by mouth at various points throughout the 21-day cycle.
