Ibrutinib, lenalidomide, and rituximab in relapsed or refractory mantle cell lymphoma (PHILEMON): a multicentre, open-label, single-arm, phase 2 trial

Publication date: Available online 29 January 2018 Source:The Lancet Haematology Author(s): Mats Jerkeman, Christian Winther Eskelund, Martin Hutchings, Riikka Räty, Karin Fahl Wader, Anna Laurell, Helle Toldbod, Lone Bredo Pedersen, Carsten Utoft Niemann, Christina Dahl, Hanne Kuitunen, Christian H Geisler, Kirsten Grønbæk, Arne Kolstad Background Regimens based on ibrutinib alone and lenalidomide and rituximab in combination show high activity in patients with relapsed or refractory mantle cell lymphoma. We hypothesised that the combination of all three drugs would improve efficacy compared with previously published data on either regimen alone. Methods In this multicentre, open-label, single-arm, phase 2 trial, we enrolled patients aged 18 years or older with relapsed or refractory mantle cell lymphoma who had previously been treated with at least one rituximab-containing regimen, an Eastern Cooperative Oncology Group performance status score of 0–3, and at least one site of measurable disease, and who met criteria for several laboratory-assessed parameters. Treatment was divided into an induction phase of 12 cycles of 28 days with all three drugs and a maintenance phase with ibrutinib and rituximab only (cycle duration 56 days), given until disease progression or unacceptable toxicity. In the induction phase, patients received intravenous (375 mg/m2) or subcutaneous (1400 mg) rituximab once a week during cycle 1 and then once every 8 weeks. Oral ibru...

Source: The Lancet Haematology - January 30, 2018 Category: Hematology Source Type: research