Ibrutinib with venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia: A phase II study
- Author(s)
- Swaminathan, M; Ferrajoli, A; Thompson, PA; Burger, J; Borthakur, G; Takahashi, K; Estrov, Z; Bharathi, V; Bataller, A; Kadia, TM; Pemmaraju, N; Daver, N; Jabbour, E; Bose, P; Kanagal-Shamanna, R; Patel, KP; Wang, SA; Garg, N; Hwang, H; Wang, X; Qiao, W; Xu, X; Cruz, N; Ayala, A; Pierce, S; Plunkett, W; Sampath, D; Kantarjian, HM; Keating, MJ; Gandhi, V; Wierda, WG; Jain, N;
- Journal Title
- Blood Cancer Discovery
- Publication Type
- Online publication before print
- Abstract
- We explored the efficacy of the combined ibrutinib + venetoclax in patients with R/R CLL. This phase 2 study enrolled 80 patients between July 2016 and September 2018. Patients received ibrutinib for the first 3 cycles, followed by ibrutinib + venetoclax for 24 cycles. Of 79 treated patients, the median age was 61 years (IQR, 56-69); 65 (65/76, 86%) had unmutated IGHV, and 29 (37%) had either del(17p) or TP53 mutation. The median prior treatments were 1 (range, 1-3). The primary endpoint, best CR/CRi was 67%, with a bone marrow undetectable measurable residual disease (10-4 sensitivity, U-MRD4) rate of 61%. At 95.5 months median follow-up, the estimated 7-year PFS rate was 63.3%. Grade ≥3 neutropenia and thrombocytopenia occurred in 38% and 13% of patients, respectively. The 24-cycle ibrutinib + venetoclax combination led to high rates of CR/CRi and bone marrow U-MRD4 in patients with R/R CLL.
- Department(s)
- Haematology
- Publisher's Version
- https://doi.org/10.1158/2643-3230.Bcd-25-0345
- Open Access at Publisher's Site
https://doi.org/10.1158/2643-3230.Bcd-25-0345- Terms of Use/Rights Notice
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Creation Date: 2026-03-02 05:02:25
Last Modified: 2026-03-02 05:02:32