All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Patients enrolled to the study will have 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.
Chronic Lymphocytic Leukemia (CLL)
Sep 09, 2020
Apr 09, 2018
Aug 07, 2023
18 Years and older (Adult, Older Adult)
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.
University of California San Diego - Moores Cancer Center
La Jolla, 92093-0658
David Geffen School of Medicine at UCLA David Geffen School of Med
Los Angeles, 90095
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State University
Tennessee Oncology Centennial Medical Center
University of Utah / Huntsman Cancer Institute Oncology