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.
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.)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Venetoclax monotherapy
Venetoclax with anti CD20 monoclonal antibody
Memorial Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, United States
Columbia University
New York, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, United States
University of Washington
Seattle, Washington, United States
Proportion of patients able to remain off CLL/SLL directed therapy
This will be described as a percentage of all patients with available data at 12 cycles of follow up (evaluable population).
Time frame: 2 years
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