Clinical Trials

First line Treatment of WM

The ECWM has launched sucessfully its clinical trial program with the initiation of the ‚ECWM-1‘ trial for first – line treatment of WM patients in need of treatment. In this large phase III European trial it will be tested whether the addition of Bortezomib s.c (B-DRC). further improves the highly effective and non-myelosuppressive immunochemotherapy DRC (Dexamethason, Rituximab and Cyclophosphamide). This trial is already initiated in Germany and has recruited the first patients. It will offer to all patients a modern, highly effective and well tolerated treatment, which will not need anymore i.v. application after a pre-planned amendment later this year, offering Rituximab and Bortezomib s.c., and dexamethasone and cyclophosphamide as oral medication.

The trial design is shown here:

Salvage Treatment of WM

The ECWM participates in the ECWM-R1 (PCYC-1127-CA trial), which offers patients with relapsed WM in need of treatment the highly innovative chemotherapy-free combination of Rituximab/Ibrutinib. In this trial patients are randomized between Rituximab/Placebo and Rituximab/Ibrutinib. Importantly, patients who suffer from progress in the Rituximab/Placebo treatment arm, all have the chance to be treated with Ibrutinib in a cross-over within the trial. This study is an international multi-center trial with most of the participating centers from the ECWM.

The trial design is shown here: