CLL breakthrough: stopping treatment may be possible for some patients
NCT ID NCT04419519
First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This study looks at whether people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have undetectable cancer cells after venetoclax treatment can stop taking the drug and stay in remission for at least a year. Researchers will monitor 81 participants to see how many remain cancer-free without ongoing therapy. The goal is to reduce unnecessary drug exposure while maintaining disease control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Venetoclax (with or without anti-CD20 antibody)
- What this could lead to
- If successful, this could show that some CLL/SLL patients can take a break from treatment without the disease coming back quickly, reducing drug side effects and costs.
- What could go wrong
- This is a small Phase 2 study (81 people) and results may not apply to all patients. Some patients may relapse after stopping venetoclax, and the long-term safety of treatment interruption is not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
81 people
The number who actually took part.
- Started
-
May 2020
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. Exclusion Criteria (both study phases): * 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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic lymphocytic leukemia (CLL) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Columbia University
New York, New York, 10032, United States
-
Memorial Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, 07920, United States
-
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645, United States
-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
-
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, 11725, United States
-
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748, United States
-
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, 11553, United States
-
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604, United States
-
University of Washington
Seattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a bispecific antibody wipe out residual leukemia cells in High-Risk CLL?
- Can a Two-Drug combo keep CLL at bay for years? a 10-Year watch begins
- Can 3D-Printed models unlock personalized blood cancer therapies?
- Can a One-Two punch of CAR-T and lenalidomide beat tough leukemia?
- Could a protein blocker quiet Leukemia's alarm system?
- Supercharged immune cells take aim at cancer and viruses in one shot