SAKK 36/13–IBRUTINIB AND BORTEZOMIB FOLLOWED BY IBRUTINIB MAINTENANCE IN PATIENTS WITH RELAPSED AND REFRACTORY MANTLE CELL LYMPHOMA: PHASE I REPORT OF A PHASE I/II TRIAL

Abstract

completed the induction. ASCT with BEAM was performed in 125 pts (87.4%). Two pts died from septic shock during HDT-SCT. In the subgroup of 139 pts, who were evaluated by CT after induction (and before HDT-SCT) the ORR was 100% (74.8% CR, 25.2% PR). By March 1, 2017, the median follow-up of the living pts was 4 years. At that time, 41 out of 148 (27.8%) analyzed pts experienced disease relapse, and 32 pts (21.6%) had died (8 in

Combined therapy with ibrutinib and bortezomib followed by ibrutinib maintenance in relapsed or refractory mantle cell lymphoma and high-risk features: a phase 1/2 trial of the European MCL network (SAKK 36/13)

“…No patient experienced a DLT during the first cycle, i.e., the minimum of 9 patients was needed to determine that whether 560 mg daily is the RP2D of ibrutinib in combination with bortezomib. 13 Most frequent adverse events (AE) of the combination treatment were thrombocytopenia (9 patients), peripheral polyneuropathy (PNP), fatigue and anaemia (6 patients each), diarrhea and injection site reaction (5 patients each). The majority of AEs were graded G1 and G2.…”

Treatment Landscape of Relapsed/Refractory Mantle Cell Lymphoma: An Updated Review

“…The medina PFS was 18.6 months. Overall, the safety profile was well-tolerable with low incidence of neurotoxicity (14.5%) (146).…”