Clinical Trials /

VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

NCT03400176

Description:

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.

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
  • Official Title: Phase Ib Open-label Study of VAY736 and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy

Clinical Trial IDs

  • ORG STUDY ID: CVAY736Y2102
  • NCT ID: NCT03400176

Conditions

  • Chronic Lymphocytic Leukemia (CLL)

Interventions

DrugSynonymsArms
VAY736Dose Escalation
ibrutinibImbruvicaDose Escalation

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimentalIncreasing doses of VAY736 in combination with a fixed dose of ibrutinib.
  • VAY736
  • ibrutinib
Dose expansionExperimentalEvaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.
  • VAY736
  • ibrutinib

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:DLT rate
Time Frame:1 year
Safety Issue:
Description:To determine the incidence of DLTs.

Secondary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Two years
Safety Issue:
Description:To determine preliminary antitumor activity of the combination.
Measure:Time to progression (TTP)
Time Frame:Two years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • Ibrutinib
  • VAY736
  • Chronic lymphocytic leukemia
  • CLL
  • Bruton's Tyrosine Kinase
  • BTK mutation

Last Updated

February 6, 2020