Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

Summary

This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as bendamustine hydrochloride, 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. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.

Timeline

Start

2014-01-15

Primary completion

2018-08-07

Completion

2026-06-07

Publications

• Woyach JA, Perez Burbano G, Ruppert AS, Miller C, Heerema NA, Zhao W, Wall A, Ding W, Bartlett NL, Brander DM, Barr PM, Rogers KA, Parikh SA, Stephens DM, Brown JR, Lozanski G, Blachly J, Nattam S, Larson RA, Erba H, Litzow M, Luger S, Owen C, Kuzma C, Abramson JS, Little RF, Dinner S, Stone RM, Uy G, Stock W, Mandrekar SJ, Byrd JC. Follow-up from the A041202 study shows continued efficacy of ibrutinib regimens for older adults with CLL. Blood. 2024 Apr 18;143(16):1616-1627. doi: 10.1182/blood.2023021959.
• Ruppert AS, Booth AM, Ding W, Bartlett NL, Brander DM, Coutre S, Brown JR, Nattam S, Larson RA, Erba H, Litzow M, Owen C, Kuzma CS, Abramson JS, Little RF, Smith SE, Stone RM, Byrd JC, Mandrekar SJ, Woyach JA. Adverse event burden in older patients with CLL receiving bendamustine plus rituximab or ibrutinib regimens: Alliance A041202. Leukemia. 2021 Oct;35(10):2854-2861. doi: 10.1038/s41375-021-01342-x. Epub 2021 Jul 17.
• Woyach JA, Ruppert AS, Heerema NA, Zhao W, Booth AM, Ding W, Bartlett NL, Brander DM, Barr PM, Rogers KA, Parikh SA, Coutre S, Hurria A, Brown JR, Lozanski G, Blachly JS, Ozer HG, Major-Elechi B, Fruth B, Nattam S, Larson RA, Erba H, Litzow M, Owen C, Kuzma C, Abramson JS, Little RF, Smith SE, Stone RM, Mandrekar SJ, Byrd JC. Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL. N Engl J Med. 2018 Dec 27;379(26):2517-2528. doi: 10.1056/NEJMoa1812836. Epub 2018 Dec 1.

Drugs

Indications