NCT04419519Active, not recruitingPhase 2
Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax
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
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- First submitted
- 4 Jun 2020
- Start date
- 13 May 2020
- Primary completion date
- 31 May 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT04419519
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 81
- From 13 May 2020 to the primary completion date, 31 May 2027
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing participation in a clinical trial that supplies venetoclax and/or anti CD20 monoclonal antibody
Other
- 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).
Criteria the registry did not label
- Screening Phase 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:
- 3-5 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
- 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.
- Study Intervention Phase Inclusion Criteria:
- 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 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Commack (All protocol activities) Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester (All Protocol Activities) Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Monmouth (All Protocol Activities) Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan Kettering Bergen (All Protocol Activities) Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Memorial Sloan Kettering Nassau (All Protocol Activities) Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.