VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

Phase Ib Open-label Study of VAY736 and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy

ClinicalTrials.gov Identifier: NCT03400176

Novartis Reference Number: CVAY736Y2102

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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. 

Study Description

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.

Condition 
Chronic Lymphocytic Leukemia (CLL)
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
60 participants
Start date 
Apr 09, 2018
Completion date 
Aug 07, 2023
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
VAY736
Experimental
Drug
ibrutinib
Approved medication

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

Known history of HIV
Active hepatitis B or C infection
Receipt of attenuated vaccine within 2 weeks prior to starting study treatment.

Study Locations

United States
University of California San Diego - Moores Cancer Center
Recruiting
La Jolla, 92093-0658
California
United States
David Geffen School of Medicine at UCLA David Geffen School of Med
Recruiting
Los Angeles, 90095
California
United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State University
Recruiting
Columbus, 43210
Ohio
United States
Tennessee Oncology Centennial Medical Center
Recruiting
Nashville, 37203
Tennessee
United States
University of Utah / Huntsman Cancer Institute Oncology
Recruiting
Salt Lake City, 84103
Utah
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]