Study on Treatment Outcome Patterns for Patients With CLL After Discontinuation of BTK Inhibitors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This Phase II hybrid decentralized multicenter study examines the outcomes of stopping Bruton tyrosine kinase inhibitor (BTKi) therapy in patients with chronic lymphocytic leukemia (CLL) who have remained in remission for at least two years. The primary objective is to determine how long patients remain free from disease progression or death after discontinuing treatment, measured as event free survival. The study also evaluates whether stopping BTKi therapy leads to improvements in quality of life and reductions in treatment related side effects. Researchers will follow patients over time to assess if the cancer returns, whether resistance to therapy develops, and how patients feel during the treatment free period. In addition, the trial will investigate how discontinuing BTKi therapy affects immune function, including whether immune recovery occurs and infection risk decreases. Preliminary data indicate that patients may experience a treatment free interval exceeding two years after stopping therapy, with associated improvements in quality of life. By prospectively evaluating a time limited treatment strategy, this trial aims to determine whether durable disease control can be maintained off therapy while also assessing the resolution of BTKi related adverse events and changes in patient reported outcomes. Overall, the study seeks to determine whether patients can safely discontinue BTKi therapy and potentially restart treatment later if needed, thereby maintaining disease control while reducing the burden of continuous therapy.
Interventions
- Other Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy
Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy.
Primary outcome measures
- Event-free survival (EFS) [Time frame: 2 years]
Secondary outcome measures (10)
- Progression Free Survival (PFS) [Time frame: 2 years]
- Overall Survival (OS) [Time frame: Up to 60 months]
- Time to initial detection of measurable residual disease (MRD) [Time frame: Up to 60 months]
- Overall and complete response rates [Time frame: 2 years]
- Rate of resolution of BTKi-related adverse events [Time frame: 2 years]
- Incidence of new infections [Time frame: 1 year]
- Incidence of second cancers [Time frame: 5 years]
- Association between biomarkers and disease outcomes [Time frame: 5 years]
- Change in Total Score of Functional Assessment of Cancer Therapy (FACT) -Leukemia [Time frame: Baseline and up to 6 months]
- Change in Functional Assessment of Cancer Therapy (FACT) -Leukemia physical, social, emotional, and functional well-being components [Time frame: Baseline and up to 6 months]
Eligibility criteria
Inclusion criteria
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill — Chapel Hill
Identifiers
NCT: NCT07526597 · LCCC2522-DCT