This phase 3 study is evaluating the effectiveness and safety of two different chemotherapy regimens for patients with mantle cell lymphoma (MCL). The main outcome to be measured will be the number of patients who survive without tumor growth or spread. This study is recruiting in Las Vegas, Nevada in the U.S.
MCL is an aggressive type of non-Hodgkin's lymphoma. It is often treated with targeted therapies. These drugs target specific proteins or genes in cancer cells and help stop cancer growing or spreading. Ibrutinib (Imbruvica) and venetoclax (Venclexta) are two examples. Zanubrutinib is a new targeted therapy that is under investigation.
This study is evaluating the effectiveness and safety of two different chemotherapy regimens for patients with MCL. The main outcome to be measured will be progression-free survival (number of patients still alive without tumor growth or spread).
Who are they looking for?
This study is recruiting 500 patients with MCL that has not yet been treated. To participate in this study, patients should also not be eligible for a stem cell transplant (SCT).
Patients with active infections, heart disease or cancer cells in the brain or spinal cord cannot participate. Patients with a history of bleeding disorders cannot participate. Patients who seek therapy to shrink tumors before SCT cannot participate.
How will it work
Patients will be divided into two groups. In the first group, patients will receive zanubrutinib plus rituximab (Rituxan). In the second group, patients will receive bendamustine (Bendeka) plus rituximab.
Effectiveness will be measured as progression-free survival at follow-up. The number of patients who respond to treatment will also be measured. Safety will be measured as the number of patients who have side effects. Patients will be followed up for up to 7 years. During follow-up, patients will receive two questionnaires. These questionnaires will be used to evaluate outcomes after treatment.