Chronic Lymphocytic Leukemia (CLL)Phase 2NCT04419519
Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax
A Phase 2 study testing Venetoclax monotherapy and Venetoclax with anti CD20 monoclonal antibody in people with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
- What is being tested?
- Venetoclax monotherapy and Venetoclax with anti CD20 monoclonal antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 9 sitesUnited States
- Study dates
- 13 May 2020to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Memorial Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645
Columbia University
New York, New York, 10032
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
University of Washington
Seattle, Washington, 98109
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, 11553
About this study
Official title: 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
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.
Read the detailed 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.)
- Being tested
- Venetoclax monotherapy, Venetoclax with anti CD20 monoclonal antibody
- Keywords
- Venetoclax, Anti-CD20 monoclonal antibody, 19-395
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venetoclax monotherapyDrug
Venetoclax monotherapy
Venetoclax with anti CD20 monoclonal antibodyDrug
Venetoclax with anti CD20 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax monotherapy | Experimental | Not described Receives: Drug: Venetoclax monotherapy |
| Venetoclax with anti-CD20 monoclonal antibody | Experimental | Not described Receives: Drug: Venetoclax with anti CD20 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start13 May 2020
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter clinical stopping trial for venetoclax-treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients.
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Adaptive Biotechnologies
- Responsible party
- Sponsor
- Investigators
- Meghan Thompson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419519
- Sponsor's protocol ID
- 19-395
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2020
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04419519
- Acronym / sponsor ID
- 19-395
- Keywords
- Venetoclax, Anti-CD20 monoclonal antibody, 19-395
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Adaptive Biotechnologies
- Study start
- 13 May 2020 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicenter clinical stopping trial for venetoclax-treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients.
| Arm | Type | Receives |
|---|---|---|
| Venetoclax monotherapy | Experimental | Drug: Venetoclax monotherapy |
| Venetoclax with anti-CD20 monoclonal antibody | Experimental | Drug: Venetoclax with anti CD20 monoclonal antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venetoclax monotherapyVenetoclax monotherapy | Drug | Venetoclax monotherapy |
| Venetoclax with anti CD20 monoclonal antibodyVenetoclax with anti CD20 monoclonal antibody | Drug | Venetoclax with anti-CD20 monoclonal antibody |
Primary outcome
Proportion of patients able to remain off CLL/SLL directed therapy
Time frame: 2 years
This will be described as a percentage of all patients with available data at 12 cycles of follow up (evaluable population).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan Thompson, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax monotherapy and Venetoclax with anti CD20 monoclonal antibody in people with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients able to remain off CLL/SLL directed therapy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.