NCT07819214尚未招募2 期
Epcoritamab as Consolidation Therapy for High-risk Patients With Chronic Lymphocytic Leukemia on Bruton Tyrosine Kinase Inhibitor
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Rate of Undetectable Measurable Residual Disease (uMRD) at End of Treatment
研究概览
简要总结
This is a phase 2, single-arm, open-label clinical trial determining efficacy of Epcoritamab in subjects with Chronic Lymphocytic Leukemia (CLL) on Burton Tyrosine Kinase Inhibitor (BTKi).
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
- •Patients with CLL and at least 1 of the following risk factors:
- •≥1 prior line of therapy before BTKi
- •17p deletion and/or TP53 mutation
- •Complex karyotype (≥3 chromosomal abnormalities)
- •Treated with a BTKi for ≥ 6 months
- •Receiving or able to obtain a commercial supply of BTKi
- •Measurable residual disease defined as the presence of CLL cells by conventional flow cytometry
- •ALC ≤10 K/mcL
- •Lymph nodes ≤5 cm in the longest diameter
- •Normal organ function and hematologic parameters
- •ECOG performance status of 0-1
排除标准
- •Active CNS involvement
- •Active immune-mediated cytopenias
- •Current or prior Richter's transformation
- •Second active malignancy requiring treatment (excluding non-melanamatous skin cancers and cancers requiring hormonal therapies alone such as breast/prostate cancer)
- •Pregnant or breastfeeding
研究组 & 干预措施
Epcoritamab
Experimental
Given IV
干预措施: Epcoritamab (Drug)
结局指标
主要结局
Rate of Undetectable Measurable Residual Disease (uMRD) at End of Treatment
时间窗: 1 year
Efficacy will be determined by rate of uMRD at EOT for both Epcoritamab and BTKi discontinuation
次要结局
- Number of Participants with Complete Remission (CR) by International Workshop on CLL (iwCLL) criteria(1 year)
研究者
Catherine Coombs
Associate Clinical Professor
University of California, Irvine
研究点 (1)
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