Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)

Summary

This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.

Timeline

Start

2017-06-19

Primary completion

2024-06-26

Completion

2024-06-27

Publications

• Wang M, Hoffmann MS, Wrobel T, Trneny M, Belada D, Demirken F, Panayiotidis P, Jurczak W, Zinzani PL, Keating MM, Yoon SS, Egyed M, Tam CS, Johnson NA, Szafer Glusman E, Lin J, Dean JP, Neuenburg JK, von Keudell G. First-line ibrutinib plus venetoclax for non-blastoid mantle cell lymphoma in patients >/=65 years or with TP53 mutations. Blood. 2026 Jul 1:blood.2025032833. doi: 10.1182/blood.2025032833. Online ahead of print.
• Wang M, Jurczak W, Trneny M, Belada D, Wrobel T, Ghosh N, Keating MM, van Meerten T, Alvarez RF, von Keudell G, Thieblemont C, Peyrade F, Andre M, Hoffmann M, Szafer-Glusman E, Lin J, Dean JP, Neuenburg JK, Tam CS. Ibrutinib plus venetoclax in relapsed or refractory mantle cell lymphoma (SYMPATICO): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2025 Feb;26(2):200-213. doi: 10.1016/S1470-2045(24)00682-X.
• Wang M, Ramchandren R, Chen R, Karlin L, Chong G, Jurczak W, Wu KL, Bishton M, Collins GP, Eliadis P, Peyrade F, Lee Y, Eckert K, Neuenburg JK, Tam CS. Concurrent ibrutinib plus venetoclax in relapsed/refractory mantle cell lymphoma: the safety run-in of the phase 3 SYMPATICO study. J Hematol Oncol. 2021 Oct 30;14(1):179. doi: 10.1186/s13045-021-01188-x.

Drugs

Indications