2024-514687-33-00招募中2 期
Venetoclax and delayed rituximab with ibrutinib consolidation aiming at undetectable minimal residual disease (uMRD) in treatment-naïve patients with chronic lymphocytic leukemia (CLL)
Ospedale San Raffaele S.r.l.14 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2024年8月5日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 14
- 主要终点
- uMRD (<10-4) evaluated by 6-color cytofluorymetry in BM as the best response at any time during treatment up to 3 months after supplementation of combination therapy (VR or VR followed by VI)
研究概览
简要总结
Evaluate the effectiveness of the sequential combination of venetoclax, delayed rituximab and ibrutinib in terms of minimal remaining undetectable disease (uMRD, <10- 4) detected with 6-color cytofluorimetry in BM as the best response at any time during treatment up to 3 months after the completion of combined therapy
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age =18 but <65 years
- •Active CLL/SLL requiring treatment according to iwCLL 2018 criteria
- •No previous CLL/SLL therapy
- •Appropriate medullary function: a. ANC =1.0 x 109/L; B. Plt =25 x 109/L; c. Hb =8.0 g/dl
排除标准
- •Previous treatment for CLL/SLL
- •Known history of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C (HCV). Subjects who are positive for HBcAb, HBsAb or the hepatitis C antibody should have a negative result of the polymerase chain reaction (PCR) prior to enlistment. Those who test positive for PCR will be excluded.
- •Note hypersensitivity to one or more drugs in the study
- •Known hemorrhagic disorders (e.g. von Willebrand's disease) or haemophilia
- •History of stroke or intracranial bleeding in the 6 months prior to enlistment
- •Major surgery within 4 weeks of first dose of the drug in the study
- •Cardiovascular disease currently active and clinically significant such as uncontrolled arrhythmia or congestive heart failure of class 3 or 4 as defined by the functional classification of the New York Heart Association or a history of myocardial infarction, unstable angina
- •History of other malignant malignancies, except in situ carcinoma or malignant cancers treated with curative intent
- •Known story or suspected transformation of Richter
- •Hypersensitivity known to one or more drugs in the study
- •Inadequate kidney function: CrCl <30 ml/min
- •Autoimmune hemolytic anemia or uncontrolled autoimmune platelets
- •Need for warfarin or derivatives therapy
- •Treatment within 7 days before the first dose of the drug in the study with one of the following: a. Steroid therapy with antineoplastic intent B. Moderate or powerful cytochrome inhibitors P450 3A (CYP3A) (see Appendix G for examples) C. Moderate or strong CYP3A inducers (see Appendix G for examples)
- •Administration or consumption of any of the following within 3 days before the first dose of the drug in the study: a. Pompelmo or grapefruit products B. Seville oranges (including jam containing Seville oranges) c. Carambola
结局指标
主要结局
uMRD (<10-4) evaluated by 6-color cytofluorymetry in BM as the best response at any time during treatment up to 3 months after supplementation of combination therapy (VR or VR followed by VI)
uMRD (<10-4) evaluated by 6-color cytofluorymetry in BM as the best response at any time during treatment up to 3 months after supplementation of combination therapy (VR or VR followed by VI)
次要结局
未报告次要终点
研究者
Paolo Ghia
Scientific
Ospedale San Raffaele S.r.l.
研究点 (14)
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