VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/26/2018
Start Date:April 9, 2018
End Date:October 21, 2019
Contact:Novartis Pharmaceuticals
Email:Novartis.email@novartis.com
Phone:1-888-669-6682

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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.
We found this trial at
2
sites
Novartis Investigative Site
Columbus, Ohio 43205
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Columbus, OH
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Novartis Investigative Site
Nashville, Tennessee 37205
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Nashville, TN
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