VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03400176
Collaborator
(none)
60
Enrollment
5
Locations
2
Arms
78.2
Anticipated Duration (Months)
12
Patients Per Site
0.2
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 DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 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 :
Oct 14, 2022
Anticipated Study Completion Date :
Oct 15, 2024

Arms and Interventions

ArmIntervention/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

    1. DLT rate [1 year]

      To determine the incidence of DLTs.

    Secondary Outcome Measures

    1. Overall Response Rate (ORR) [Two years]

      To determine preliminary antitumor activity of the combination.

    2. 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:
    No
    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

    SiteCityStateCountryPostal Code
    1University of California San Diego - Moores Cancer CenterLa JollaCaliforniaUnited States92093-0658
    2David Geffen School of Medicine at UCLA David Geffen School of MedLos AngelesCaliforniaUnited States90095
    3Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State UniversityColumbusOhioUnited States43210
    4Tennessee Oncology Centennial Medical CenterNashvilleTennesseeUnited States37203
    5University of Utah / Huntsman Cancer Institute OncologySalt Lake CityUtahUnited States84103

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03400176
    Other Study ID Numbers:
    • CVAY736Y2102
    First Posted:
    Jan 17, 2018
    Last Update Posted:
    Dec 6, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 6, 2021