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    Ibrutinib plus venetoclax in relapsed/refractory chronic lymphocytic leukemia: the CLARITY study

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    Authors
    Hillmen, P
    Rawstron, A
    Brock, K
    Munoz-Vicente, S
    Yates, F
    Bishop, R
    Boucher, R
    MacDonald, D
    Fegan, C
    McCaig, A
    Schuh, A
    Pettitt, A
    Gribben, J
    Patten, P
    Devereux, S
    Bloor, Adrian
    Fox, C
    Forconi, F
    Munir, T
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    Affiliation
    Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, United Kingdom
    Issue Date
    2019
    
    Metadata
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    Abstract
    PURPOSE: The treatment of chronic lymphocytic leukemia (CLL) has been revolutionized by targeted therapies that either inhibit proliferation (ibrutinib) or reactivate apoptosis (venetoclax). Both significantly improve survival in CLL and replace chemoimmunotherapy for many patients. However, individually, they rarely lead to eradication of measurable residual disease (MRD) and usually are taken indefinitely or until progression. We present the CLARITY trial that combined ibrutinib with venetoclax to eradicate detectable CLL with the intention of stopping therapy. PATIENTS AND METHODS: CLARITY is a phase II trial that combined ibrutinib with venetoclax in patients with relapsed or refractory CLL. The primary end point was eradication of MRD after 12 months of combined therapy. Key secondary end points were response by International Workshop on CLL criteria, safety, and progression-free and overall survival. RESULTS: In 53 patients after 12 months of ibrutinib plus venetoclax, MRD negativity (fewer than one CLL cell in 10,000 leukocytes) was achieved in the blood of 28 (53%) and the marrow of 19 (36%). Forty-seven patients (89%) responded, and 27 (51%) achieved a complete remission. After a median follow-up of 21.1 months, one patient progressed, and all patients were alive. A single case of biochemical tumor lysis syndrome was observed. Other adverse effects were mild and/or manageable and most commonly were neutropenia or GI events. CONCLUSION: The combination of ibrutinib plus venetoclax was well tolerated in patients with relapsed or refractory CLL. There was a high rate of MRD eradication that led to the cessation of therapy in some patients. The progression-free and overall survival rates are encouraging for relapsed and refractory CLL.
    Citation
    Hillmen P, Rawstron A, Brock K, Munoz-Vicente S, Yates FJ, Bishop R, et al. Ibrutinib plus venetoclax in relapsed/refractory chronic lymphocytic leukemia: the CLARITY study. J Clin Oncol. 2019.
    Journal
    Journal of Clincal Oncology
    URI
    http://hdl.handle.net/10541/622055
    DOI
    10.1200/JCO.19.00894
    PubMed ID
    31295041
    Additional Links
    https://dx.doi.org/10.1200/JCO.19.00894
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1200/JCO.19.00894
    Scopus Count
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