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Study on Discontinuing BTK Inhibitors for CLL

This study is looking at what happens when people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) stop taking Bruton tyrosine kinase inhibitors (BTKi). You might be able to join if you are 18 or older, have CLL or SLL, and have been in remission for at least two years while on BTKi therapy. The main goal is to see how long people stay free from their cancer progressing or returning after stopping BTKi, measured over two years. Researchers also want to see if stopping treatment improves your quality of life and reduces side effects. The study is currently unclear on its recruitment status.

Study design
This is a Phase II study involving about 45 participants. It is designed to examine outcomes after discontinuing BTKi therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure event-free survival for at least 2 years after discontinuing treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07526597

Study on Treatment Outcome Patterns for Patients With CLL After Discontinuation of BTK Inhibitors

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~45 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event-free survival (EFS)
Measured over 2 years

Conditions

Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

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Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Deborah Stephens, DO · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Brice Messenger
[email protected]
919-984-0000
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
Subjects is willing and able to comply with study procedures based on the judgement of the investigator.
Age ≥ 18 years at the time of consent.
Eastern Cooperative Oncology Group Performance Status of 0-3 or Karnofsky Performance Status of ≥40
Confirmed of a diagnosis of CLL (Chronic Lymphocytic Leukemia) or SLL (Small Lymphocytic Lymphoma) according to International Workshop on Chronic Lymphocytic Leukemia 2018 Guidelines at any point prior to study enrollment.
At the time of enrollment, patients must be receiving treatment with a covalent Bruton tyrosine kinase inhibitor in the first or second line setting and have been receiving this treatment for at a minimum 2 years. Patients may have previously received anti-CD20 monoclonal antibodies (such as rituximab or obinutuzumab) in combination with the cBTKi.

Exclusion

Patients must not have evidence of progressive CLL as defined by IWCLL 2018 criteria.
Participants with history of malignancy other than CLL/SLL are allowed

What this trial measures

  • Event-free survival (EFS)2 years

    EFS will be defined as the proportion of patients who remain alive, do not meet International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for initiation of next chronic lymphocytic leukemia (CLL) therapy, and have not started a new CLL - directed treatment.