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

  • STATUS
    Recruiting
  • days left to enroll
    56
  • participants needed
    80
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 22 December 2021
remission
lymphoid leukemia
chronic lymphocytic leukemia
lymphoma
monoclonal antibodies
residual tumor
venetoclax
monoclonal protein

Summary

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.

Description

Screening Phase:

Patients will be identified by clinical investigators at participating centers. Patients who sign the screening consent will undergo MRD assessment with the clonoSEQ® assay. If the assessment identifies the patient to be MRD negative, the patient will undergo a repeat MRD assessment ≥ 28 days later. If two consecutive MRD assessments indicate MRD-negativity, the patient will then 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.)

Details
Condition Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
Treatment Venetoclax monotherapy, Venetoclax with anti CD20 monoclonal antibody
Clinical Study IdentifierNCT04419519
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on22 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

≥ 18-years-old
Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma confirmed by the enrolling institution
Receiving treatment or planning to receive treatment within 30 days 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 discontinuing therapy)
Patient has or will have specimen to identify the CLL or SLL clone(s) for future MRD
assessments by clonoSEQ® defined as any of the following
Study Intervention Phase Inclusion Criteria
-5 bone marrow aspirate slides (banked), 3-5 FFPE slides (banked), banked tumor cells or banked DNA collected from the patient at any time from original diagnosis of CLL or SLL to present
Patients must have received venetoclax-based therapy for at least 6 months (including dose interruptions)
Peripheral blood, marrow, or lymph node involvement for fresh sample collection
The screening ID sample (high disease burden sample) can be sent prior to start of
venetoclax-based therapy to identify the clone for tracking
If receiving venetoclax in combination with anti-CD20 monoclonal antibody, patients must have completed the anti CD20 monoclonal antibody portion of the regimen prior to discontinuing therapy
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 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

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)
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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