Ibrutinib Plus Venetoclax in Relapsed/Refractory Chronic Lymphocytic Leukemia - The CLARITY Study

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Abstract

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. 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.

Publication
Journal of Clinical Oncology

About this publication

This publication is important to me because Clarity was my first successful grant application. It is a simple trial with modest sample size but the results are absolutely amazing, with an iwCLL response rate of 89% and minimum disease negative status achieved in the peripheral blood of 53% of patients.

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Kristian Brock
Principal Biostatistician

I am an academic early phase clincial trial statistician.

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