Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing

Summary

This research study is studying a drug called ibrutinib as a possible treatment for untreated Waldenstrom's Macroglobulinemia (WM).

Timeline

Start

2016-01

Primary completion

2022-11-01

Completion

2022-11-01

Publications

• Sun H, Sklavenitis-Pistofidis R, Liu S, Liu X, Tsakmaklis N, Hatcher JM, Guerrera ML, Kofides A, Ramirez-Gamero A, Peachey AL, Li S, Keskin DB, Chea V, Kim N, Lyu H, Lu W, Livak KJ, Meid K, Guijosa A, Flynn CA, Pizzarella D, Patterson CJ, Hao M, Yi S, Yuan W, Branagan AR, Wu CJ, Ghobrial IM, Qiu L, Sarosiek SR, Castillo JJ, Hunter ZR, Treon SP. Evolution of tumor subclones and T-cell dynamics underlie variable ibrutinib responses in Waldenstrom macroglobulinemia. Blood. 2026 May 14;147(20):2298-2314. doi: 10.1182/blood.2025032268.
• Guijosa A, Ramirez-Gamero A, Sarosiek S, Branagan AR, von Keudell G, Treon SP, Castillo JJ. Ibrutinib plus rituximab vs ibrutinib monotherapy in patients with Waldenstrom macroglobulinemia: a pooled analysis. Blood Adv. 2025 Sep 23;9(18):4705-4715. doi: 10.1182/bloodadvances.2025016536.
• Castillo JJ, Meid K, Gustine JN, Leventoff C, White T, Flynn CA, Sarosiek S, Demos MG, Guerrera ML, Kofides A, Liu X, Munshi M, Tsakmaklis N, Xu L, Yang G, Branagan AR, O'Donnell E, Raje N, Yee AJ, Patterson CJ, Hunter ZR, Treon SP. Long-term follow-up of ibrutinib monotherapy in treatment-naive patients with Waldenstrom macroglobulinemia. Leukemia. 2022 Feb;36(2):532-539. doi: 10.1038/s41375-021-01417-9. Epub 2021 Sep 16.
• Treon SP, Gustine J, Meid K, Yang G, Xu L, Liu X, Demos M, Kofides A, Tsakmaklis N, Chen JG, Munshi M, Chan G, Dubeau T, Raje N, Yee A, O'Donnell E, Hunter ZR, Castillo JJ. Ibrutinib Monotherapy in Symptomatic, Treatment-Naive Patients With Waldenstrom Macroglobulinemia. J Clin Oncol. 2018 Sep 20;36(27):2755-2761. doi: 10.1200/JCO.2018.78.6426. Epub 2018 Jul 25.

Drugs

Indications