One-Year combo pill strategy may boost CLL remission rates
NCT ID NCT06520098
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at 100 people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are already taking a BTKi pill (like ibrutinib). Half will keep taking the BTKi alone, while the other half will add a second pill called venetoclax for one year. After that year, both pills are stopped and participants are closely watched. The goal is to see if the combination leads to more complete remissions and less fatigue.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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.
Inclusion Criteria: * CLL or SLL diagnosis * Patients must have been diagnosed with CLL (\> 5000 B-cells per uL of peripheral blood at any point during the course of their disease) or small lymphocytic lymphoma (SLL) with \<5000 B-cells per µL of blood but with disease-associated lymphadenopathy by 2018 IWCLL criteria. * Prior treatment * Patients must be currently receiving CLL/SLL directed therapy with a BTKi (i.e., ibrutinib, acalabrutinib, zanubrutinib) for at least six months. * The dose of BTKi must be stable for at least the past three months. * Age 18 years * ECOG performance status 0-2 * Detectable or measurable CLL/SLL in blood or imaging during the screening period. Detectable CLL/SLL in the blood is defined either by elevation in absolute lymphocyte count or by diagnostic flow cytometry from blood demonstrating presence of CLL cells. * Low TLS risk, defined as having all lymph nodes less than 5 cm in diameter (radiographically) and absolute lymphocyte count less than 25 x 109/L in blood, within 30 days of enrollment. * Required initial laboratory values * Absolute Neutrophil Count (ANC) 1,000/mm3 except if due to bone marrow involvement * Platelet Count (untransfused) 30,000/mm3 except if due to bone marrow involvement * Calc. Creatinine Clearance 40 mL/min (by Cockcroft-Gault) * Bilirubin 1.5 x upper limit of normal (ULN) except if due to liver involvement, hemolysis, or Gilbert's disease * AST / ALT 2.5 x upper limit of normal (ULN) except if due to liver involvement * Other * Patients must be able to swallow oral medications and not have the following conditions: disease significantly affecting gastrointestinal absorption, resection of the stomach or small bowel, partial or complete bowel obstruction. * Patients must be able to receive either a xanthine oxidase inhibitor or rasburicase Exclusion Criteria: * Prior treatment * Patients must not have progression of CLL/SLL on BTKi therapy prior to initiation of the study therapy. * Patients must not have received the combination of BTKi + venetoclax previously. * Comorbid conditions or other active diseases * Patients must not have any history of Richter's transformation or prolymphocytic leukemia. * If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable and be on suppressive therapy, if indicated. * Please note: IVIG can cause a false positive hepatitis B serology. If patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician. * If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load. * Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible. * Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy are eligible for this trial. * Concomitant medications * Patients must not be receiving active systemic anticoagulation with heparin or warfarin. Patients on warfarin must discontinue the drug for at least 10 days prior to registration on the study. * Chronic concomitant treatment with strong inhibitors of CYP3A4/5 is not recommended on this study. Patients on strong CYP3A inhibitors must discontinue the drug for 14 days prior to registration on the study or discuss with the study principal investigator. * Chronic concomitant treatment with strong CYP3A4/5 inducers is not recommended. Patients must discontinue the drug 14 days prior to registration on the study or discuss with the study principal investigator. * Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily. * Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Durham VA Medical Center, Durham, NC
RECRUITINGDurham, North Carolina, 27705-3875, United States
Contact Email: •••••@•••••
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Kansas City VA Medical Center, Kansas City, MO
RECRUITINGKansas City, Missouri, 64128-2226, United States
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San Francisco VA Medical Center, San Francisco, CA
RECRUITINGSan Francisco, California, 94121-1563, United States
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VA Puget Sound Health Care System Seattle Division, Seattle, WA
RECRUITINGSeattle, Washington, 98108-1532, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo aims to push CLL into deep remission
- Can a new BTK inhibitor outsmart resistance in CLL?
- Can a new pill outsmart Drug-Resistant leukemia?
- Can engineered immune cells beat tough B-Cell cancers?
- Can a targeted drug outperform chemo for a common blood cancer?
- Can a triple drug combo outsmart High-Risk CLL?