Clinical Trials /

Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax

NCT04419519

Description:

This study will find out whether people with CLL or SLL who have received treatment with venetoclax, either alone or in combination with another drug, and who are found to be MRD-negative, can stop treatment with venetoclax and remain off-treatment for 12 months or more. The researchers will also see whether study participants remain MRD-negative after they stop treatment with venetoclax.

Related Conditions:
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax
  • Official Title: Veneto-STOP Study: Sequential Assessment of Minimal Residual Disease by Next Generation Sequencing to Optimize Outcomes and Minimize Exposure in Venetoclax-Treated CLL/SLL Patients

Clinical Trial IDs

  • ORG STUDY ID: 19-395
  • NCT ID: NCT04419519

Conditions

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)

Interventions

DrugSynonymsArms
Venetoclax monotherapyVenetoclax monotherapy
Venetoclax with anti CD20 monoclonal antibodyVenetoclax with anti-CD20 monoclonal antibody

Purpose

This study will find out whether people with CLL or SLL who have received treatment with venetoclax, either alone or in combination with another drug, and who are found to be MRD-negative, can stop treatment with venetoclax and remain off-treatment for 12 months or more. The researchers will also see whether study participants remain MRD-negative after they stop treatment with venetoclax.

Detailed Description

      Screening Phase:

      Patients will be identified by clinical investigators at participating centers. Patients who
      sign the screening consent patients will undergo an MRD assessment with the clonoSEQ® assay.
      If the assessment identifies the patient to be MRD negative, the patient will undergo a
      repeat MRD assessment no less than 28 days later. If two consecutive MRD assessments indicate
      MRD-negativity, the patient will then be directed to sign the study intervention phase
      informed consent form and will undergo the rest of the screening process.

      Enrollment

      Once the patient fulfills all eligibility criteria, the patient will be enrolled into one of
      two cohorts based on the type of therapy they are receiving at the time of enrolled:

      Cohort A: Venetoclax monotherapy at time of enrollment.

      Cohort B: Venetoclax with anti CD20 monoclonal antibody at time of enrollment (The latter
      includes patients who initiated anti CD20 monoclonal antibody with venetoclax and have since
      completed the anti CD20 monoclonal antibody portion of the regimen.)
    

Trial Arms

NameTypeDescriptionInterventions
Venetoclax monotherapyExperimental
  • Venetoclax monotherapy
Venetoclax with anti-CD20 monoclonal antibodyExperimental
  • Venetoclax with anti CD20 monoclonal antibody

Eligibility Criteria

        Screening Phase Inclusion Criteria:

          -  ≥ 18-years-old

          -  Diagnosis of Chronic lymphocytic leukemia or Small lymphocytic lymphoma confirmed by
             the enrolling institution

          -  Receiving treatment with a venetoclax-based regimen as defined below:

               -  Venetoclax monotherapy

               -  Venetoclax in combination with anti CD20 monoclonal antibody (Patients must have
                  completed the anti CD20 monoclonal antibody portion of the regimen prior to
                  signing consent)

          -  Patients must be receiving commercially supplied venetoclax (and anti CD20 monoclonal
             antibody)Have 3-5 bone marrow aspirate slides (fresh or banked), 3-5 FFPE slides
             (fresh or banked), available banked tumor cells or DNA, or fresh blood sample
             collected from the patient at any time from original diagnosis of CLL to present to
             identify the CLL clone(s) for future MRD assessments by clonoSEQ®.

        Study Intervention Phase Inclusion Criteria:

          -  Patients must have received venetoclax-based therapy for at least 6 months (including
             dose interruptions)

          -  Patients must have two MRD-negative assessments (defined by ≥ 10^-5 sensitivity) on
             the peripheral blood by the clonoSEQ® assay at least 28 days apart. Given that MRD
             status is a dynamic endpoint which may improve with time, if a patient is screen
             failure based on MRD status (i.e. MRD positive at the 10-5 sensitivity), they may be
             rescreened for MRD status every three months to assess for study eligibility. Patients
             must have achieved a complete or partial remission with the venetoclax-based regimen.
             Criteria for remission are per iwCLL 2018 guidelines. For this protocol, bone marrow
             biopsy/aspirate evaluation is not necessary to determine remission status.

        Exclusion Criteria (both study phases):

          -  Participation in a clinical trial that supplies venetoclax and/or anti CD20 monoclonal
             antibody

          -  Unwilling or unable to participate in all required study evaluations and procedures.

          -  Unable to understand the purpose and risks of the study and to provide a signed and
             dated informed consent form (ICF) and authorization to use protected health
             information (in accordance with national and local patient privacy regulations).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of patients able to remain off CLL directed therapy
Time Frame:2 years
Safety Issue:
Description:This will be described as a percentage of all patients with available data at 12 cycles of follow up (evaluable population).

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Venetoclax
  • Anti-CD20 monoclonal antibody
  • 19-395

Last Updated

June 4, 2020