RecruitingPhase 2NCT06520098

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)

Benefit of Venetoclax Addition ("Benefit VA") in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)


Sponsor

VA Office of Research and Development

Enrollment

100 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

People who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) are often treated with ibrutinib, acalabrutinib, or zanubrutinib. These are pills that are taken by mouth. This type of pill is called "Bruton Tyrosine Kinase Inhibitor" or BTKi. Another treatment for CLL/SLL is a different pill called venetoclax. The purpose of this study is to compare continuing the current treatment with BTKi alone, as long as it is working, to another arm of treatment which adds venetoclax to the current treatment (BTKi), for one year. After one year, both pills in this arm of treatment would be stopped and the participants will be closely monitored.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is for veterans with a type of blood cancer called chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are already being treated with a BTK inhibitor drug (like ibrutinib, acalabrutinib, or zanubrutinib). It is testing whether adding venetoclax (a second targeted cancer drug) can improve outcomes. **You may be eligible if...** - You have been diagnosed with CLL or SLL - You have been on a BTK inhibitor for at least 6 months with a stable dose for the last 3 months - You are 18 or older and in reasonably good health (ECOG 0–2) - Your disease is still detectable (in blood tests or imaging) - Your lymph nodes are less than 5 cm and your white cell count is not extremely high (low tumor lysis risk) **You may NOT be eligible if...** - Your CLL or SLL has progressed while on the BTK inhibitor - You have previously received a BTK inhibitor combined with venetoclax - You have a history of Richter's transformation (conversion to a more aggressive lymphoma) - You have active hepatitis B - You have problems absorbing oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.

DRUGIbrutinib, Acalabrutinib, Zanubrutinib

IMBRUVICA is a kinase inhibitor Acalabrutinib is a selective, irreversible small molecule inhibitor of BTK. Zanubrutinib is BTK inhibitors


Locations(4)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

Kansas City VA Medical Center, Kansas City, MO

Kansas City, Missouri, United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06520098


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