Ibrutinib with venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia: A phase II study

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.

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Publication Details

Journal
Blood Cancer Discovery
Published
2026-02-12
DOI
https://doi.org/10.1158/2643-3230.bcd-25-0345
Primary Topic
Chronic Lymphocytic Leukemia Research
Type
article
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article

Ibrutinib with venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia: A phase II study

Alex Bataller, Z Estrov, Prithviraj Bose, Alessandra Ferrajoli et al.
Blood Cancer Discovery
Chronic Lymphocytic Leukemia Research
article

Ibrutinib with venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia: A phase II study

Alex Bataller, Z Estrov, Prithviraj Bose, Alessandra Ferrajoli, Deepa Sampath, Mahesh Swaminathan, Vanthana Bharathi, Hyunsoo Hwang, Nichole Cruz, Xuemei Wang, Wei Qiao, MJ Keating, Ana Ayala, Varsha Gandhi, Keyur P. Patel, Nitin Jain, Hagop M. Kantarjian, Naveen Pemmaraju, Philip A. Thompson, William Plunkett, Gautam Borthakur, Jan Burger, William G. Wierda, Naval G. Daver, Sa A. Wang, Xun Xu, Sherry Pierce, Tapan M. Kadia, Naveen Garg, Koichi Takahashi, Elias Jabbour
article en

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.

Blood Cancer Discovery
The University of Texas MD Anderson Cancer Center (US), Peter MacCallum Cancer Centre (AU)
Good health and well-being
Openalex Percentile: Top 58%
Chronic Lymphocytic Leukemia Research
DOISourceOpenAlex
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