Overview

VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

Status:
Recruiting

Trial end date:
2024-10-15

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

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.