Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of MCL

Summary

Phase II study with a two-stage design to evaluate efficacy and safety of ibrutinib in combination with rituximab (I+R) in untreated patients with indolent clinical forms of MCL. An extensive biological study will be conducted in order to further characterize this population of MCL patients and evaluate the response obtained with the mutational profile of the tumor.

Timeline

Start

2016-05-18

Primary completion

2019-12

Completion

2029-12

Publications

• Gine E, de la Cruz F, Jimenez Ubieto A, Lopez Jimenez J, Martin Garcia-Sancho A, Terol MJ, Gonzalez Barca E, Casanova M, de la Fuente A, Marin-Niebla A, Muntanola A, Gonzalez-Lopez TJ, Aymerich M, Setoain X, Cortes-Romera M, Rotger A, Rodriguez S, Medina Herrera A, Garcia Sanz R, Nadeu F, Bea S, Campo E, Lopez-Guillermo A. Ibrutinib in Combination With Rituximab for Indolent Clinical Forms of Mantle Cell Lymphoma (IMCL-2015): A Multicenter, Open-Label, Single-Arm, Phase II Trial. J Clin Oncol. 2022 Apr 10;40(11):1196-1205. doi: 10.1200/JCO.21.02321. Epub 2022 Jan 14.

Drugs

Indications