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AACR 2022: Fixed-Duration Regimen of Ibrutinib/Venetoclax for CLL With High-Risk Features

By: Joshua D. Madera, MS
Posted: Friday, April 29, 2022

Combination treatment with ibrutinib and venetoclax in patients with chronic lymphocytic leukemia (CLL) with high-risk features may lead to sustained progression-free survival and treatment-free remissions, according to the international, multicenter phase II CAPTIVATE trial presented at the American Association for Cancer Research (AACR) Annual Meeting 2022 (Abstract CT028). These benefits were observed in patients with and without high-risk features, commented John N. Allan, MD, of Weill Cornell Medicine, New York, and colleagues.

A total of 202 patients with CLL were recruited for the study. Patients either received combination treatment with ibrutinib plus venetoclax (n = 159) or a placebo (n = 43). Patients were stratified into two cohorts: one with a fixed-duration treatment of three cycles of ibrutinib and 12 cycles of ibrutinib plus venetoclax, and one with subsequent treatment based on measurable residual disease (MRD) status.

The current analysis focused on 129 patients with high-risk features of CLL that included deletions in 17p, mutations in TP53, no mutations in IGHV, or a complex karyotype. The median duration of treatment was 13.8 and 11.1 months for ibrutinib and venetoclax treatment, respectively. In addition, the comparison of progression-free survival rates in patients with and without high-risk features was 94% and 97%, respectively. Furthermore, the findings revealed an 18-month landmark estimate for duration of complete remission of 95%.

Moreover, adverse effects due to treatment with ibrutinib plus venetoclax were recorded in 3% of patients, with no additional safety findings identified. Adverse effects identified included neutropenia and hypertension.

Disclosure: For full disclosures of the study authors, visit

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