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Exploring Novel Ibrutinib Combinations in Clinical Trials for CLL

Jennifer A. Woymach, MD
Published Online:2:00 PM, Thu January 16, 2020

Jennifer A. Woymach, MD, an associate professor for the Leukemia Research Program at the Ohio State University Comprehensive Cancer Center, provides background information on the AO41702 study, which evaluates targeted therapy ibrutinib (Imbruvica) or ibrutinib plus rituximab (Rituxan) in elderly patients with previously untreated chronic lymphocytic leukemia (CLL).

The A041702 study is the successor to AO41202. In 2018, results from the randomized AO41202 study showed that ibrutinib or ibrutinib/rituximab was superior to bendamustine plus rituximab in treatment-naïve elderly patients with CLL.

The goal of A041702 is to optimize targeted treatment by allowing a mechanism for therapy discontinuation while still including a BTK inhibitor in the treatment plan.

AO41702 includes patients aged 70 years or older and randomizes them 1:1 to either ibrutinib plus obinutuzumab (Gazyva) or ibrutinib plus obinutuzumab plus venetoclax (Venclexta). Patients in the ibrutinib/obinutuzumab arm receive the standard 6 cycles of obinutuzumab and are treated with ibrutinib indefinitely. The triplet arm is given the standard obinutuzumab and will complete a total of 14 cycles of ibrutinib and venetoclax.

After about 1 year, patients in the study will undergo a response evaluation. Participants who have a minimal residual disease complete response (CR) will discontinue all study therapy. Patients who do not have a CR will continue ibrutinib indefinitely.
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