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A Phase II Study of Ibrutinib Plus FCR as Frontline Therapy in Younger CLL Patients

Matthew S. Davids, MD
Published Online:4:49 PM, Wed February 7, 2018

Matthew S. Davids, MD, associate director, Center for Chronic Lymphocytic Leukemia at Dana-Farber Cancer Institute, discusses a multicenter study of ibrutinib (Imbruvica) plus fludarabine, cyclophosphamide, and rituximab (Rituxan; FCR) as a frontline therapy for younger patients with chronic lymphocytic leukemia (CLL). 

There are many effective therapy options available for the treatment of CLL, Davids says. Older, frailer patients with CLL may not need to receive a more aggressive regimen, such as this combination, and may benefit from novel agents instead.

This study focused on a younger, more fit population of CLL patients under the age of 65 who could tolerate a more aggressive treatment approach. The aim of the study was to build on the experience of FCR alone, which has been shown to have a curative potential for low-risk forms of CLL.

This study included patients with mutated and unmutated IGHV. Patients were given the combination of ibrutinib and FCR for up to 6 months, followed by 2 years of ibrutinib maintenance therapy.

Results of the first 35 patients on this trial were reported at the 2017 ASH Annual Meeting. Typically, FCR alone induces about a 20% complete response (CR) rate. In this study, CR was nearly doubled, at 37% with the combination. Investigators did not see any additional side effects than what has been seen with either regimen alone, Davids notes.

Davids also notes that patients who received ibrutinib maintenance therapy experienced a deepening of response over time. Additionally, the rate of best bone marrow minimal residual disease negativity reached 83%, which is the highest rate that has been seen in any CLL regimen to date.
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