Ibrutinib, Rituximab, and Consolidation Chemotherapy in Treating Young Patients With Newly Diagnosed Mantle Cell Lymphoma

Summary

This phase II trial studies how well ibrutinib, rituximab, and consolidation chemotherapy consisting of cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate, and cytarabine work in treating young patients with newly diagnosed mantle cell lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving ibrutinib together with rituximab and consolidation chemotherapy may be a better treatment for mantle cell lymphoma.

Timeline

Start

2015-06-03

Primary completion

2027-06-30

Completion

2027-06-30

Publications

• Wang ML, Jain P, Zhao S, Lee HJ, Nastoupil L, Fayad L, Ok CY, Kanagal-Shamanna R, Hill HA, Yao Y, Hagemeister FB, Westin JR, Fowler N, Samaniego F, Steiner R, Nair R, Iyer SP, Navsaria L, Badillo M; Mantle Cell Research Group; Feng L, Xuelin H, Nogueras Gonzalez GM, Xu G, Wagner-Bartak N, Thirumurthi S, Santos D, Tang G, Lin P, Wang SA, Jorgensen J, Yin CC, Li S, Patel KP, Vega F, Medeiros LJ, Flowers CR, Wang L. Ibrutinib-rituximab followed by R-HCVAD as frontline treatment for young patients (</=65 years) with mantle cell lymphoma (WINDOW-1): a single-arm, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):406-415. doi: 10.1016/S1470-2045(21)00638-0. Epub 2022 Jan 21.
• Jain P, Zhao S, Lee HJ, Hill HA, Ok CY, Kanagal-Shamanna R, Hagemeister FB, Fowler N, Fayad L, Yao Y, Liu Y, Moghrabi OB, Navsaria L, Feng L, Nogueras Gonzalez GM, Xu G, Thirumurthi S, Santos D, Iliescu C, Tang G, Medeiros LJ, Vega F, Avellaneda M, Badillo M, Flowers CR, Wang L, Wang ML. Ibrutinib With Rituximab in First-Line Treatment of Older Patients With Mantle Cell Lymphoma. J Clin Oncol. 2022 Jan 10;40(2):202-212. doi: 10.1200/JCO.21.01797. Epub 2021 Nov 19.
• Jain P, Romaguera J, Srour SA, Lee HJ, Hagemeister F, Westin J, Fayad L, Samaniego F, Badillo M, Zhang L, Nastoupil L, Kanagal-Shamanna R, Fowler N, Wang ML. Four-year follow-up of a single arm, phase II clinical trial of ibrutinib with rituximab (IR) in patients with relapsed/refractory mantle cell lymphoma (MCL). Br J Haematol. 2018 Aug;182(3):404-411. doi: 10.1111/bjh.15411. Epub 2018 May 22.

Drugs

Indications