Phase 2 study of acalabrutinib in ibrutinib (IBR)-intolerant patients (pts) with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)
| Autor: | Kerry A. Rogers, Raquel Izumi, Jeff Porter Sharman, Rakesh Raman, Thomas J. Kipps, Morton Coleman, Philip A. Thompson, Min Hui Wang, Cheng Seok Quah, John N. Allan, Bruce D. Cheson, Melanie M. Frigault |
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| Rok vydání: | 2019 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty biology business.industry Chronic lymphocytic leukemia Phases of clinical research medicine.disease Discontinuation 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine chemistry 030220 oncology & carcinogenesis Ibrutinib Internal medicine Relapsed refractory medicine biology.protein Acalabrutinib Bruton's tyrosine kinase Adverse effect business 030215 immunology |
| Zdroj: | Journal of Clinical Oncology. 37:7530-7530 |
| ISSN: | 1527-7755 0732-183X 0271-7611 |
| Popis: | 7530 Background: In CLL pts treated with the Bruton tyrosine kinase (BTK) inhibitor IBR, the most common reason for discontinuation was adverse events (AEs; 50%-63%; Mato et al, 2018). This Phase 2 trial evaluated acalabrutinib, a highly selective, potent, covalent BTK inhibitor, in IBR-intolerant pts with R/R CLL. Methods: Pts with R/R CLL (≥1 prior therapy) who discontinued IBR due to Gr 3/4 AEs or persistent/recurrent Gr 2 AEs and had progressive disease (PD) after IBR discontinuation were eligible. Acalabrutinib was given at 100 mg BID PO in 28-d cycles until PD or unacceptable toxicity. The primary endpoint was overall response rate (ORR). Results: 60 pts were treated (median age 70 y [range 43-88]). Pt characteristics included bulky disease ≥5 cm (33%), Rai stage III/IV (47%), del17p (28%), del11q (23%) and unmutated IGHV (79%). 52/55 (95%) pts with available baseline samples were wild type for BTK and PLCG2. Median number of prior therapies was 2 (range 1-10). Median duration of prior IBR therapy was 6 mo (range |
| Databáze: | OpenAIRE |
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