Type

Range

Units

Status

Start Date

End Date

Financing

Partner

Brief description/objective

According to current European guidelines (Dreyling, Ann Oncol 2014), the standard of care in younger patients with mantle cell lymphoma (MCL) is a dose-intensified approach with a cytarabine containing immunochemotherapy induction followed by autologous transplantation (ASCT; Hermine, ICML 2013). Ibrutinib has recently shown im-pressive efficacy data in relapsed MCL while tolerability was rather favorable (Wang, NEJM 2013). Based on these prerequisites, our study proposal challenges the current standard of care and questions, whether the addition of ibrutinib (arm A+I) to the standard (control arm A) results in a superior clinical outcome. In addition, we investigate whether ASCT which sometimes is hampered by short and long term toxicity is still superior to a (hopefully much better tolerated) conventional treatment without ASCT and with the addition of ibrutinib in induction and maintenance (duration 2 years, arm I). As so far combination data are only available with the R-CHOP regimen, ibrutinib is only applied in combination with R-CHOP. There will be an initial safety run-in phase of 50 patients which will be closely monitored for the observed toxicities during induction. Analysis of minimal residual disease (MRD) will play a crit-ical role in identifying specific patient subpopulations which may be especially prone to one of the three therapeutical strategies. According to the recently completely recruited LyMa trial rituximab maintenance may be added to all 3 study arms depending on national guidelines.