An official website of the United States government
Assessing Minimal Residual Disease to Minimize Exposure in Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia Who Have Been Treated with Venetoclax, Veneto-STOP Study
Trial Status: active
This phase II trial assesses minimal residual disease to minimize exposure in patients with chronic lymphocytic leukemia or small lymphocytic leukemia who have been treated with venetoclax. Stopping treatment with venetoclax in MRD-negative chronic lymphocytic leukemia or small lymphocytic leukemia patients could help prevent the serious side effects that can occur during long-term treatment with this drug. This trial may help researchers find out whether patients who are currently receiving treatment with venetoclax can stop treatment and remain off-treatment for at least 12 months, if they are free of residual disease (MRD-negative) when they stop treatment.
Inclusion Criteria
SCREENING PHASE OF THE STUDY
>= 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 be receiving or plan to receive commercially supplied venetoclax (and anti CD20 monoclonal antibody)
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:
* 3-5 bone marrow aspirate slides (banked), 3-5 formalin-fixed paraffin-embedded (FFPE) slides (banked), banked tumor cells, or banked deoxyribonucleic acid (DNA) collected from the patient at any time from original diagnosis of CLL or SLL to present
* 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
INTERVENTION PHASE OF THE STUDY
Patients must have received venetoclax-based therapy for at least 6 months (including dose interruptions)
If receiving venetoclax in combination with anti-CD20 monoclonal antibody, patients must have completed or discontinued 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 >= 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 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines. For this protocol, bone marrow biopsy/aspirate evaluation is not necessary to determine remission status
Exclusion Criteria
Ongoing 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)
Additional locations may be listed on ClinicalTrials.gov for NCT04419519.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Meghan Caitlin Thompson
Phone: 646-608-4253
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Meghan Caitlin Thompson
Phone: 646-608-4253
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Meghan Caitlin Thompson
Phone: 646-608-4253
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Meghan Caitlin Thompson
Phone: 646-608-4253
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Meghan Caitlin Thompson
Phone: 646-608-4253
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Meghan Caitlin Thompson
Phone: 646-608-4253
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Meghan Caitlin Thompson
Phone: 646-608-4253
PRIMARY OBJECTIVE:
I. To evaluate whether patients are able to remain off chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) directed therapy at 12 cycles (1 cycle = 28 days) following venetoclax-based treatment discontinuation.
SECONDARY OBJECTIVES:
I. To estimate the cumulative incidence of minimal residual disease (MRD) positivity during the study observation period of 36 cycles following discontinuation.
II. To estimate the cumulative incidence of new CLL/SLL directed therapy initiation at 36 cycles following venetoclax-based treatment discontinuation.
III. To estimate progression-free survival (PFS) as measured from start of treatment free observation.
IV. To estimate overall survival (OS) as measured from start of treatment free observation.
V. To evaluate whether outcomes (proportion of patients able to remain off CLL/SLL directed therapy, PFS, OS) at 12 cycles following treatment discontinuation is different among patients previously treated with venetoclax monotherapy versus (vs.) venetoclax in combination with anti-CD20 antibody.
VI. To estimate the overall response rate (ORR) and the complete response rate (CRR) in the subset of patients who require retreatment with CLL/SLL directed therapy during study observation period, described in aggregate and separated by CLL/SLL-directed treatment regimen received in retreatment.
VII. To estimate the minimal residual disease negativity rate in the subset of patients who require retreatment with CLL/SLL directed therapy during study observation period.
VIII. To describe the adverse event profile for venetoclax-based therapy retreatment.
IX. Quality of life assessment (AQoL-8D) pre- and post-venetoclax discontinuation for MRD negative patients.
X. To describe the baseline mutational and cytogenetic profiles of patients (including cytogenetics, next generational sequencing mutational profiles and IGHV mutational status) prior to the venetoclax treatment under study and at progression, if this testing is available for patients.
OUTLINE:
Patients stop receiving treatment with venetoclax and undergo collection of blood samples every 3 months for 36 months to find out whether blood and bone marrow has any remaining active cancer cells (MRD status). Patients whose cancer comes back and need to re-start treatment with venetoclax before 36 months continue to undergo MRD testing for at least another year, but no longer than 24 months from stopping venetoclax. Patients also undergo magnetic resonance imaging (MRI) or computed tomography (CT) scans as clinically indicated.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
