This phase 3 trial is investigating the safety and effectiveness of ibrutinib (Imbruvica) plus venetoclax (Venclexta) for mantle cell lymphoma (MCL). The main outcomes to be measured will be survival without cancer growing or spreading and side effects of treatment.
The details
Mantle cell lymphoma (MCL) is an aggressive type of non-Hodgkin's lymphoma. It is often treated with targeted therapies. These drugs target specific proteins or genes on cancer cells and help stop cancer growing or spreading. Ibrutinib and venetoclax are such targeted therapies.
This study is evaluating the safety and effectiveness of ibrutinib with or without venetoclax for MCL. The main outcomes to be measured will be progression-free survival (time from treatment until tumor growth or spread) and side effects of treatment.
Who are they looking for?
This study is recruiting 287 participants with MCL. Patients should have received at least 1 but no more than 5 prior treatments for MCL.
Patients should not have lymphoma in the brain or nervous system. Patients should not have received prior therapy with ibrutinib or venetoclax.
How will it work
In this study, there will be two different groups. In the first group, patients will receive ibrutinib and venetoclax. In the second group, patients will receive ibrutinib with placebo.
Safety will be measured as the number of patients who experience side effects within 3 months of starting treatment. Effectiveness will be measured as progression-free survival at 1 year after stopping treatment.
