Chronic Lymphocytic Leukemia Coverage from Every Angle

Does Idelalisib Increase the Risk of Bleeding Events in Patients With CLL?

By: Sarah Campen, PharmD
Posted: Friday, January 15, 2021

The PI3K-delta inhibitor idelalisib does not appear to increase the risk of bleeding events when used simultaneously with anticoagulation or antiplatelet therapy in patients with relapsed chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin lymphoma (NHL), according to the results of a post hoc analysis published in Leukemia & Lymphoma. Another agent routinely used in the treatment of B-cell malignancies, ibrutinib, has been associated with an increased risk of bleeding in this population. “Although the data presented do not change the known risk-benefit profile for idelalisib use, it may be informative when considering next-line therapy for patients with relapsed/refractory CLL or indolent NHL at high risk for major bleeding events,” stated John M. Pagel, MD, PhD, of the Swedish Cancer Institute, Seattle, and colleagues.

The data from 345 patients enrolled in 2 idelalisib trials—rituximab ± idelalisib in CLL (n = 220) and idelalisib monotherapy in indolent NHL (n = 125)—were analyzed. Concomitant anticoagulant or antiplatelet use at any time on study was frequent in all treatment groups, including idelalisib plus rituximab (63%), placebo plus rituximab (36%), and idelalisib monotherapy (47%). The most commonly used medications were aspirin, enoxaparin, heparin, and warfarin.

The incidence of bleeding was comparable across treatment groups, ranging from 14% to 19% (P = .56). Bleeding events of grade 3 or greater occurred in 0.9% and 3.2% of the idelalisib-treated CLL and indolent NHL cohorts, respectively. Fewer patients treated with idelalisib experienced bleeding events while receiving antiplatelet therapy than while receiving anticoagulant therapy.

Disclosure: For full disclosures of the study authors, visit

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