VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

Novartis

Status and phase: Terminated; Phase 1

Conditions: Chronic Lymphocytic Leukemia (CLL)

Treatments: Drug: ibrutinib; Drug: VAY736

Study type: Interventional

Funder types: Industry

Identifiers

NCT03400176

5R01CA177292-09 (U.S. NIH Grant/Contract)

CVAY736Y2102

Details and patient eligibility

About

Patients enrolled to the study had chronic lymphocytic leukemia (CLL) and received ibrutinib. Patients had either received ibrutinib for one year without having had a complete response or patients developed a resistance mutation to ibrutinib. This study had two parts, a dose escalation part and a dose expansion part.

Enrollment: 39 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Dose Escalation

Experimental group

Description:

Increasing doses of VAY736 in combination with a fixed dose of ibrutinib.

Treatment:

Drug: VAY736

Drug: ibrutinib

Dose expansion

Experimental group

Description:

Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.

Treatment:

Drug: VAY736

Drug: ibrutinib