Study on Treatment Outcome Patterns for Patients With CLL After Discontinuation of BTK Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have been receiving covalent Bruton tyrosine kinase inhibitors for at least 2 years and have achieved a clinical remission.
干预措施: Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy (Other)
结局指标
主要结局
Event-free survival (EFS)
时间窗: 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.
次要结局
- Incidence of new infections(1 year)
- Progression Free Survival (PFS)(2 years)
- Overall Survival (OS)(Up to 60 months)
- Time to initial detection of measurable residual disease (MRD)(Up to 60 months)
- Overall and complete response rates(2 years)
- Rate of resolution of BTKi-related adverse events(2 years)
- Incidence of second cancers(5 years)
- Association between biomarkers and disease outcomes(5 years)
- Change in Total Score of Functional Assessment of Cancer Therapy (FACT) -Leukemia(Baseline and up to 6 months)
- Change in Functional Assessment of Cancer Therapy (FACT) -Leukemia physical, social, emotional, and functional well-being components(Baseline and up to 6 months)