VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
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.
Arms and Interventions
|Experimental: Dose Escalation|
Increasing doses of VAY736 in combination with a fixed dose of ibrutinib.
|Experimental: Dose expansion|
Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.
Primary Outcome Measures
- DLT rate [1 year]
To determine the incidence of DLTs.
Secondary Outcome Measures
- Overall Response Rate (ORR) [Two years]
To determine preliminary antitumor activity of the combination.
- Time to progression (TTP) [Two years]
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.
Contacts and Locations
|1||University of California San Diego - Moores Cancer Center||La Jolla||California||United States||92093-0658|
|2||David Geffen School of Medicine at UCLA David Geffen School of Med||Los Angeles||California||United States||90095|
|3||Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State University||Columbus||Ohio||United States||43210|
|4||Tennessee Oncology Centennial Medical Center||Nashville||Tennessee||United States||37203|
|5||University of Utah / Huntsman Cancer Institute Oncology||Salt Lake City||Utah||United States||84103|
Sponsors and Collaborators
- Novartis Pharmaceuticals
Study Documents (Full-Text)None provided.