Study of BTKi with or without Venetoclax for CLL/SLL in Veterans
This study is for Veterans with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). You may be eligible if you are currently taking a Bruton Tyrosine Kinase Inhibitor (BTKi) like ibrutinib, acalabrutinib, or zanubrutinib. The study aims to see if adding venetoclax to your current BTKi treatment for one year, and then stopping both medications, is better than continuing BTKi alone. Researchers will measure how many participants achieve a complete response (CR) after 24-36 months. This study plans to enroll 100 participants aged 18 to 80.
- Study design
- This is a randomized interventional study, meaning participants will be assigned by chance to one of the treatment groups. It plans to enroll 100 participants.
- What's involved
- Participants will continue their current BTKi treatment or add venetoclax for one year, after which both pills in the combination arm would be stopped and participants closely monitored.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, complete response, will be measured at 24-36 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06520098
A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Recruiting
PHASE2Ages 18–80InterventionalTreatmentVA Office of Research and DevelopmentGovernment-funded
~100 participants
Updated 2025-10-14 on ClinicalTrials.gov
What's tested:VenetoclaxIbrutinib, Acalabrutinib, Zanubrutinib
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary objective is to evaluate complete response (CR) rate, per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, 2018
Measured over 24-36 months
Conditions
Where it's being run
4 sites across 4 statesCalifornia1
Missouri1
North Carolina1
Washington1
Study leadership
- Suman Kambhampati, MD MBBS · PRINCIPAL_INVESTIGATOR · Kansas City VA Medical Center, Kansas City, MO
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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
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
What this trial measures
- The primary objective is to evaluate complete response (CR) rate, per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, 201824-36 months
The addition of Venetoclax to BTKi for 12 months will improve CR compared to use of BTKi alone in CLL/SLL patients who are already receiving BTKi therapy as treatment.