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John F. Seymour, MBBS, FRACP, PhD, discusses the design of the phase 3 ELEVATE-RR trial comparing acalabrutinib vs ibrutinib in chronic lymphocytic leukemia.
John F. Seymour, MBBS, FRACP, PhD, director, Integrated Haematology Department, clinical hematologist, associate director of Clinical Research, Peter MacCallum Cancer Centre, Victoria Australia, discusses the design of the phase 3 ELEVATE-RR trial (NCT02477696) comparing acalabrutinib (Calquence) vs ibrutinib (Imbruvica) in chronic lymphocytic leukemia (CLL).
The design of the ELEVATE-RR trial followed the format of a nonblinded study in which patients with previously treated, high-risk CLL were randomized 1:1 to ibrutinib or acalabrutinib, Seymour says. Moreover, regarding dosing of the oral BTK inhibitors, acalabrutinib was given at 100 mg twice daily, and ibrutinib was given at 420 mg once daily, Seymour explains.
Additionally, the primary end point of the trial was noninferiority by independent review committee–assessed progression-free survival, Seymour continues. Several prespecified secondary end points were included, including the incidence of any-grade atrial fibrillation or flutter, which is a recognized toxicity with BTK inhibitors, Seymour concludes.