Chronic Lymphocytic Leukemia Clinical Trial

VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

Summary

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.

View Eligibility Criteria

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 is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

39

Study ID:

NCT03400176

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 7 Locations for this study

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University of California San Diego - Moores Cancer Center
La Jolla California, 92093, United States
David Geffen School of Medicine at UCLA David Geffen School of Med
Los Angeles California, 90095, United States
University of Chicago
Chicago Illinois, 60637, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State University
Columbus Ohio, 43210, United States
Tennessee Oncology Centennial Medical Center
Nashville Tennessee, 37203, United States
University of Utah / Huntsman Cancer Institute Oncology
Salt Lake City Utah, 84103, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

39

Study ID:

NCT03400176

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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