Venetoclax and delayed rituximab with ibrutinib consolidation aiming at undetectable minimal residual disease (uMRD) in treatment-naïve patients with chronic lymphocytic leukemia (CLL) - VALUABLE

OSPEDALE SAN RAFFAELE0 个研究点目标入组 55 人开始时间: 2021年8月2日最近更新: 2022年3月2日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 55

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Age =18 but <65 years
•2. Active CLL/SLL requiring treatment according to iwCLL 2018 criteria
•3. No previous CLL/SLL therapy
•4. Appropriate medullary function:
•a. ANC =1.0 x 109/L;
•B.Plt =25 x 109/L;
•c. Hb =8.0 g/dl
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 55
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Previous treatment for CLL/SLL
•2. History of other malignant malignancies, except in situ carcinoma or malignant cancers treated with curative intent
•3. Known story or suspected transformation of Richter
•4. Hypersensitivity known to one or more drugs in the study
•5. Inadequate kidney function: CrCl <30 ml/min
•6. Autoimmune hemolytic anemia or uncontrolled autoimmune platelets
•7. Need for warfarin or derivatives therapy
•8. 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)
•9. 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
•10. 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.
•11. Note hypersensitivity to one or more drugs in the study
•12. Known hemorrhagic disorders (e.g. von Willebrand's disease) or haemophilia
•13. History of stroke or intracranial bleeding in the 6 months prior to enlistment
•14. Major surgery within 4 weeks of first dose of the drug in the study
•15. 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

研究者

发起方

OSPEDALE SAN RAFFAELE

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