Number: CALGB A041202 Principal Investigator: Bartlett, Nancy
Title: A Randomized Phase III Study of Bendamustine plus Rituximab versus Ibrutinib plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (= 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)
Phase: III Disease Site: Lymphoid Leukemia
Participating Site(s):
Main Campus
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South County
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St. Peters
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West County
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Contact: 800-600-3606 or

The purpose of this study is to compare the effects, good and/or bad, of the drug ibrutinib, either alone or in
combination with the drug rituximab, with the standard treatment for this disease. The standard treatment is
chemotherapy with the drug bendamustine in combination with the drug rituximab. The effects on you and
your leukemia will be looked at to find out which treatment is better. Both bendamustine and rituximab are
approved by the FDA to treat chronic lymphocytic leukemia (your leukemia type), but ibrutinib is considered investigational. In this study, you will get either the drug ibrutinib alone, or ibrutinib with rituximab, or bendamustine with rituximab. If you are in the group that receives bendamustine with rituximab and your disease returns, you will have the option to receive ibrutinib.
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Internal Protocol Documents (requires Siteman administrative database password)