Study on Using Next-Generation Sequencing to Reduce Treatment in People with CLL or SLL Treated with Venetoclax

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04419519

Provider View

This study is exploring whether people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have been treated with venetoclax and are found to have no minimal residual disease (MRD) can safely stop treatment and remain off it for at least 12 months.

Patient Parameters

Program Overview

The purpose of this study is to determine if patients with CLL or SLL who have been treated with venetoclax, either alone or with another drug, and are MRD-negative, can stop taking venetoclax and stay off treatment for a year or more. Researchers will also check if these patients remain MRD-negative after stopping the treatment.

Description

Screening Phase:

Patients will be identified by doctors at participating centers. Those who agree to participate will have their MRD levels checked using the clonoSEQ® test. If the test shows no MRD, a second test will be done at least 28 days later. If both tests show no MRD, the patient will sign a consent form to continue with the study and complete the rest of the screening.

Enrollment:

Once all eligibility criteria are met, patients will be placed into one of two groups based on their current treatment:

  • Cohort A: Patients taking only venetoclax.
  • Cohort B: Patients taking venetoclax with an anti-CD20 monoclonal antibody. This includes those who started with both drugs but have finished the anti-CD20 part of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Currently receiving or planning to receive venetoclax-based treatment within 30 days, which can be:
    • Venetoclax alone.
    • Venetoclax with an anti-CD20 monoclonal antibody (must have completed the anti-CD20 part before stopping treatment).
  • Must have samples available to identify the CLL or SLL cells for future MRD testing using clonoSEQ®.
  • The initial sample for identifying the disease can be sent before starting venetoclax treatment.

Study Intervention Phase Inclusion Criteria:

  • Must have been on venetoclax-based treatment for at least 6 months, including any breaks in treatment.
  • If on venetoclax with an anti-CD20 antibody, must have completed or stopped the anti-CD20 part before stopping treatment.
  • Must have two MRD-negative results from blood tests at least 28 days apart using the clonoSEQ® test.
  • Must have achieved complete or partial remission with venetoclax treatment, as per specific guidelines. Bone marrow tests are not needed to confirm remission.

Exclusion Criteria

  • Currently participating in another clinical trial that provides venetoclax or anti-CD20 monoclonal antibody.
  • Unwilling or unable to participate in all required study evaluations and procedures.
  • Unable to understand the study's purpose and risks, or unable to provide signed consent and authorization to use health information.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.