This medicines trial compares three different treatment regimens in patients with advanced mantle cell lymphoma. In particular, the efficacy and tolerability of the trial medication ibrutinib will be tested. The aim of this study is to improve the treatment outcome for mantle cell lymphoma.
Mantle cell lymphoma is a specific form of Hodgkin lymphoma that is difficult to cure. Although it is possible to shrink most patients’ tumors, the majority experience a relapse at a later point in time. For this reason, the first stage of treatment (induction therapy) will attempt to completely regress the tumor, while the second stage will endeavor to consolidate this regression.
Patients will be assigned to one of three groups on a random basis (randomized study). Randomized studies are an internationally recognized method that enables scientific comparison of treatments. One group of patients will be treated with the current standard treatment of combination immunochemotherapy for the induction phase, followed by high-dose chemotherapy accompanied by stem cell transplantation for the consolidation phase. The second group will receive ibrutinib combined with one element of the induction therapy. Following consolidation treatment with high-dose chemotherapy and stem cell transplantation, they will additionally receive maintenance therapy with ibrutinib for a period of two years. The third group will also be given ibrutinib combined with one element of the induction therapy before going on to two-year maintenance therapy with ibrutinib instead of consolidation treatment with high-dose chemotherapy and stem cell transplantation.
This trial will last approximately 10 years and take place in up to 250 trial centers internationally, 12 of which are in Switzerland. Approximately 870 patients will take part, including approximately 50 in Switzerland.