This study is for patients who have advanced-stage Mantle Cell Lymphoma (MCL). Treatment for MCL with chemotherapy often results in a reduction in tumour size, but many patients experience a relapse later (recurrence of the disease). Because of this, current treatment usually involves two stages. The initial treatment (induction treatment) aims to shrink the tumour as much as possible. This is followed by a second phase of treatment (consolidation treatment) to consolidate this reduction in tumour size.
There are several different treatment options for MCL. The best option for a patient depends on their age, fitness and whether their doctor thinks they are a good candidate for a stem cell transplant.
The aim of this study is to improve the treatment outcome for patients with MCL. In this study, three different treatment options are being compared. Patients will be randomly assigned to one of the three treatment arms; treatment Arm A, Arm A+I or Arm I. Arms A+I and I include the IMP Ibrutinib, which might improve outcomes in MCL patients.
Patients randomised to Arm A will receive the standard treatment for MCL, which is what they would be likely to receive if they were not in the trial. This involves 3 cycles of R-CHOP chemotherapy alternating with 3 cycles of R-DHAP chemotherapy, followed by an autologous stem cell transplant (ASCT). Patients randomised to arm A+I will receive the same treatment, but Ibrutinib will be given alongside the R-CHOP chemotherapy. These patients will also receive 2 years of ibrutinib maintenance treatment after the ASCT. Patients randomised to Arm I will also receive R-CHOP+I alternating with R-DHAP, but will not be given ASCT and will instead proceed directly to ibrutinib maintenance. All patients will be followed-up for a period of time after completing treatment.