A Comparison of Three Approved Treatment Regimens for Mantle Cell Lymphoma: Which One Is Best?

Mantle cell lymphoma (MCL) is a malignant disease of the lymphocytes, a subtype of white blood cells that are part of the body’s immune system. It affects what are known as B-lymphocytes, and MCL is classified as a type of non-Hodgkin lymphoma. MCL is usually characterized by enlarged lymph nodes, an enlarged spleen, and an elevated number of lymphocytes in the blood. In addition to the lymph nodes, the cancer cells can also occur in the bone marrow and, for example, in the intestines. The causes of MCL are largely unknown, but genetic mutations play a role. Treatment becomes necessary when the patient develops symptoms or the MCL is clearly progressing. Treatment is then tailored to the patient’s age and physical condition. In young patients, chemotherapy (standard regimens: CHOP, DHAP) and the antibody rituximab are typically used. Studies show that combining treatment with the already approved tyrosine kinase inhibitor ibrutinib or an autologous stem cell transplant can further improve treatment outcomes. In an autologous stem cell transplant, the patient’s own hematopoietic stem cells are first collected; this is followed by very intensive chemotherapy, after which the cells are reinfused into the patient (via a vein) to allow the body to recover from the intensive chemotherapy. It is not yet clear which of the standard treatment regimens is the most effective.

The goal of this Phase 3 study is to investigate the efficacy and safety of three established treatment regimens for MCL. Participants will be randomly assigned to one of three groups as part of the study. Group 1 will receive alternating cycles of immunochemotherapy with R-CHOP and R-DHAP, followed by an autologous stem cell transplant. Group 2 will receive alternating cycles of immunochemotherapy with R-CHOP plus ibrutinib and R-DHAP, followed by an autologous stem cell transplant and maintenance therapy with ibrutinib. Group 3 receives alternating cycles of immunochemotherapy with R-CHOP plus ibrutinib and R-DHAP, followed by maintenance therapy with ibrutinib. Group 3 does not receive a stem cell transplant. The study is open-label, meaning that both the medical staff and the patient know which medications are being administered. Treatments and follow-up examinations as part of the study will continue for up to 10 years, during which the efficacy of the therapies and the occurrence of side effects from the various medications will be evaluated.

Patients between the ages of 18 and 65 with mantle cell lymphoma are eligible to participate in this study. The disease must not have been previously treated and must be stage 2–4.