VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03400176

Collaborator

(none)

Enrollment

Locations

Arms

80.3

Anticipated Duration (Months)

5.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia (CLL)	Drug: VAY736 Drug: ibrutinib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 9, 2018

Anticipated Primary Completion Date :

Dec 16, 2024

Anticipated Study Completion Date :

Dec 16, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation Increasing doses of VAY736 in combination with a fixed dose of ibrutinib.	Drug: VAY736 Experimental Drug: ibrutinib Approved medication Other Names: Imbruvica
Experimental: Dose expansion Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.	Drug: VAY736 Experimental Drug: ibrutinib Approved medication Other Names: Imbruvica

Arm

Intervention/Treatment

Experimental: Dose Escalation

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

Drug: VAY736

Experimental

Drug: ibrutinib

Approved medication

Other Names:

Imbruvica

Experimental: Dose expansion

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

Drug: VAY736

Experimental

Drug: ibrutinib

Approved medication

Other Names:

Imbruvica

Outcome Measures

Primary Outcome Measures

DLT rate [1 year]
To determine the incidence of DLTs.

Secondary Outcome Measures

Overall Response Rate (ORR) [Two years]
To determine preliminary antitumor activity of the combination.
Time to progression (TTP) [Two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Diego - Moores Cancer Center	La Jolla	California	United States	92093-0658
2	David Geffen School of Medicine at UCLA David Geffen School of Med	Los Angeles	California	United States	90095
3	University of Chicago	Chicago	Illinois	United States	60637
4	Duke University Medical Center	Durham	North Carolina	United States	27710
5	Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State University	Columbus	Ohio	United States	43210
6	Tennessee Oncology Centennial Medical Center	Nashville	Tennessee	United States	37203
7	University of Utah / Huntsman Cancer Institute Oncology	Salt Lake City	Utah	United States	84103