NCT04992377尚未招募2 期
A Multicenter Phase 2 Study of R-EPOCH in Combination With Ibrutinib for Patients With Classical Richter Transformation of Chronic Lymphocytic Leukemia
Institute of Hematology & Blood Diseases Hospital, China11 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年8月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 11
- 主要终点
- 2-year overall survival rate (OS)
研究概览
简要总结
This is an investigator-initiated Phase 2 study, which combines R-EDOCH with Ibrutinib to treat patients with Ritcher Transformation in consideration of DLBCL and CLL components both could being targeted at the same time. The investigator will observe the 2-year overall survival rate of this regimen for RT and explore the new regimen for RT in the novel drugs era, which aims to improve the efficacy and prolong survival.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Confirmed Richter transformation, whether or not previously treated
- •Unexposed to BTKi, or discontinue BTKi more than 1 year (due not to toxicity or ineffectiveness)
- •No serious liver, kidney, heart and other complications; including: a. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); b. total bilirubin (TBIL) ≤ 1.5 times the ULN; c. serum creatinine (Cr) ≤ 2 times the ULN, or glomerular filtration rate ≥ 40ml/min; d. LVEF > 50% determined by echocardiography; e. no arrhythmia and active heart disease, such as coronary heart disease, myocardial infarction, etc
- •The patient agreed to participate and signed the informed consent form
排除标准
- •Major surgery within 4 weeks prior to first dose of ibrutinib
- •Require receiving anticoagulation with warfarin or equivalent Vitamin K antagonists; Requires treatment with a strong CYP3A4/5 inhibitor
- •Require corticosteroid , anti-cancer drugs, immunomodulatory or Chinese medicine for other medical conditions
- •Pregnant or lactating women
- •History of prior malignancy
- •Currently active clinically significant cardiovascular disease
- •Uncontrolled active systemic fungal, bacterial, viral, or other infection
- •Known history of human immunodeficiency virus (HIV) or active infection with Hepatitis B or Hepatitis C
- •History of stroke or intracranial hemorrhage prior to randomization
- •Other conditions that is unfit for the clinical trial in the investigator' opinion
研究组 & 干预措施
R-EPOCH plus IBR for RT
Experimental
干预措施: R-EPOCH in Combination With Ibrutinib (Drug)
结局指标
主要结局
2-year overall survival rate (OS)
时间窗: 2 years
Defined as the time interval from enrollment to death of patients in the intent-to-treat population (ITT). If the patient is alive or death of the patient is unknown, the date of death will be the latest time point at which the patient was known to be alive.
次要结局
- Complete response rate (CRR)(1 month after completion of consolidation therapy)
- Overall response rate (ORR)(1 month after completion of consolidation therapy)
- Progression-free survival (PFS)(2 years)
- Minimal residual disease (MRD) negative rate(1 month after completion of consolidation therapy)
- Toxic side effects(3 years)
研究者
Tingyu Wang
associate chief physician
Institute of Hematology & Blood Diseases Hospital, China
研究点 (11)
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