EUCTR2020-004910-37-BE进行中（未招募）1 期
A randomized phase II trial evaluating Ibrutinib plus CD20 Ab and Ibrutinib-Venetoclax plus CD20 Ab in patients with untreated mantle cell lymphoma - OASISII
YSARC0 个研究点目标入组 194 人开始时间: 2021年3月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 194
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
- •Histologically confirmed (according to the WHO classification) mantle cell lymphoma. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin D1 or the t(11;14) translocation (by cytogenetics and/or FISH and/or BCL1-IgH PCR)
- •Untreated MCL
- •Stage II-IV disease, measurable with at least lymph node > 1.5 cm and requiring treatment in the opinion of the treating clinician
- •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 154
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
- •2.Impaired organ function (other than liver and renal) which will interfere with the treatment
- •3.Hemoglobin level < 10g/dL; Neutrophil count <1 G/L; Platelets < 75 G/L (except if related to lymphoma then platelet must be >50),
- •4.Major surgery within 28 days before enrollment
- •5.Known central nervous system lymphoma
- •6.History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- •7.Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumone)
- •8.Requires treatment with strong CYP3A inhibitors
- •9.Vaccinated with live, attenuated vaccines within 6 months of enrollment (except COVID vaccine)
- •10.Known history of human immunodeficiency virus (HIV)
- •11.Evidence of other clinically significant uncontrolled condition(s) including but not limited to:
- •-Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- •-Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. HBs antigen negative, anti-HBs antibody + and antiHBc antibody -) and subjects with anti-HB-core antibody that are HBV DNA negative may participate
- •12.Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study
- •13.Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’ opinion, could compromise the patient safety, interfere with the absorption or metabolism of treatment (Ibrutinib, CD20 Ab, venetoclax) or put the study outcomes at undue risk
- •14.Pregnant, planning to become pregnant, or lactating woman
- •15.Known hypersensitivity to study treatment (CD20 Ab, Ibrutinib, Venetoclax) or to any of the excipients
- •16.Known allergy to xanthine oxidase inhibitors or rasburicase
- •17.Known G6DP deficiency
- •18.Known bleeding disorders
- •19.Severe prior reactions to monoclonal antibodies or with prior significant toxicity (other than thrombocytopenia) from Bcl-2 inhibitor
- •20.History of prior other malignancy with the exception of:
- •-curatively treated basal cell carcinoma
- •-curatively treated squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study
- •-other curatively treated cancer and patient disease-free for over 5 years
- •21.Anti-cancer therapies including chemotherapy, radiotherapy or other investigational therapy, including targeted small molecule agents
- •22.Biological agents (e.g. monoclonal antibodies) for anti-neoplastic intent: excluded 30 days prior to first dose of venetoclax
- •23.Person deprived of his/her liberty by a judicial or administrative decision
- •24.Adult person under legal protection
研究者
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