Chronic Lymphocytic Leukemia Clinical Trial
VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
Patients enrolled to the study will have leukemia-cll/" >chronic lymphocytic leukemia (CLL) and are actively receiving ibrutinib. Patients will have either been receiving ibrutinib for one year without having had a complete response or patients will have developed a resistance mutation to ibrutinib. This study will have two parts, a dose escalation part and a dose expansion part. In the dose escalation part, the maximum tolerated dose (MTD) of the combination of VAY736 with ibrutinib will be determined. Once determined, the dose expansion part of the study will begin.
Diagnosis of CLL per the WHO classification
At least 18 years of age
Lack of a complete response after receiving ibrutinib for > 1 year OR presence of known ibrutinib resistance mutation
Actively receiving ibrutinib at either 420 mg (patients enrolled to the escalation arm) or at a stable dose for at least 2 months prior to starting study treatment (patients enrolled to the expansion arm)
Known history of HIV
Active hepatitis B or C infection
Receipt of attenuated vaccine within 2 weeks prior to starting study treatment.
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There are 5 Locations for this study
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Columbus Ohio, 43210, United States
Nashville Tennessee, 37203, United States
Salt Lake City Utah, 84103, United States
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