NCT05920668招募中不适用
Phase IV Observational Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Cell Lymphoma
Wang Xin1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The incidence of Grade 3 hypertension and atrial fibrillation
研究概览
简要总结
This was a multicenter observational study of Orelabrutinib in the treatment of CLL/SLL. Patients were treated with Orelabrutinib for 12 cycles. The primary end points were grade 3 hypertension and incidence of atrial fibrillation, and the secondary end points were improvement in abnormal markers, ORR,CR,PFS, and OS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18-80 years old, gender unlimited;
- •Chronic lymphocytic/small cell leukemia was confirmed by histopathology based on iwCLL criteria;
- •According to the iwCLL standard, the treatment can be certified
- •ECOG score ≤2 points;
- •Measurable lesions detected by enhanced computed tomography/magnetic resonance imaging (CT/MRI) : at least one lymph node with a maximum axis of more than 1.5cm and a measurable vertical dimension; For patients with chronic lymphocytic leukemia, only peripheral circulating lymphocyte count must be required. 5000/μL (or 5×10^9/L);
- •If the major organs are functioning normally, the following criteria are met:
- •The standard of blood routine examination shall meet:
- •Neutrophil absolute value (ANC) ≥1.0×109/L, platelet (PLT) ≥30×109/L; Unless it is confirmed that the bone marrow and hematopoietic deficiency is caused by CLL/SLL;
- •Biochemical examination shall meet the following standards:
- •TBIL < 2.0×ULN, CLL/SLL involved liver or diagnosed Gilbert syndrome (normal direct bilirubin), total bile red ≤ 3 ULN; ALT and AST < 2.5×ULN (for CLL/SLL involved liver, ALT and AST < 5×ULN); Endogenous creatinine clearance ≥30ml/min (Cockcroft-Gault formula).
- •Women of childbearing age must have been using reliable contraception or have had a pregnancy test (serum or urine) with negative results within 7 days prior to inclusion and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last test drug administration. For males, consent is required to use an appropriate method of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug;
- •Expected survival > 6 months;
- •Patients voluntarily participated in this study and signed written informed consent.
排除标准
- •Patients who have received other BTK inhibitors in the past and have progressed;
- •Patients with grade 3 hypertension
- •Patients with atrial fibrillation
- •Richter's syndrome is or has been confirmed by biopsy pathology;
- •Has active and uncontrolled autoimmune hemocytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura;
- •Present or past malignancies other than cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder carcinoma;
- •Received glucocorticoid therapy (at a dose of 20 mg/ day or higher than prednisone or equivalent) within 14 days prior to initial administration, except for inhalation, topical, intraarticular, and prophylactic use before or after use of iodized contrast agent; After discussion with the group leader, higher doses and longer steroid therapy may be permitted in the following situations:
- •Treatment of autoimmune hemolysis or autoimmune thrombocytopenia associated with CLL/SLL disease;
- •Short-term (within 14 days) use to treat non-active infections in diseases not associated with CLL/ SRL (e.g., arthritis, asthma) to acute exacerbations, including dose adjustments of steroids required for adrenal insufficiency;
- •Patients who have undergone major surgical operations (tests for diagnostic purposes) or participated in clinical trials of drugs/devices within 4 weeks;
- •Have uncontrolled or significant cardiovascular disease, including:
- •New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction, or arrhythmia requiring treatment at the time of screening, left ventricular ejection fraction (LVEF) < in the six months prior to the initial administration of the study drug; 50%;
- •Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, unestablished cardiomyopathy);
- •Clinically significant history of prolonged QTc interphase, or women with interphase QTc in screening period > 470ms, male > 450ms;
- •Subjects with symptomatic or medicated coronary heart disease;
- •Patients with uncontrolled hypertension (on the basis of improving their life style, their blood pressure is still not up to the standard after more than 1 month with the application of reasonably tolerable enough 2 or more antihypertensive drugs (including diuretics), or their blood pressure can be effectively controlled by taking 4 or more antihypertensive drugs);
- •Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN+4 s or APTT > 1.5 ULN) or had active bleeding within 2 months prior to screening, or was taking anticoagulant drugs, or had what the investigator considered a definite tendency to bleed;
- •Arteriovenous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. occurred within 12 months before enrollment;
- •Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g. inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- •Active or uncontrolled HBV (HBsAg positive and HBV DNA titer positive), HCV Ab positive or HIV positive;
- •Uncontrolled, active systemic fungal, bacterial, viral or other infection (defined as showing persistent signs/symptoms associated with the infection despite no improvement with appropriate antibiotics or other treatment);
- •Allergic disposition or hypersensitivity to obutinib or any other component of the applicable investigational drug;
- •Those who have received potent CYP3A4 inhibitor therapy within 7 days before enrollment, or potent CYP3A4 inducer therapy within 12 days before enrollment, or must also take CYP3A severely inhibiting or strongly inducible drugs;
- •Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders;
- •Participated in clinical trials of other antitumor drugs within 4 weeks before enrollment;
- •Pregnant and lactating women and subjects of childbearing age who do not want to take contraceptive measures;
- •Poor compliance or inability to follow up regularly;
- •Patients with life-threatening conditions or severe organ dysfunction are deemed unfit to participate in the study;
- •The investigator determines other circumstances that may affect the conduct of clinical studies and the determination of study results.
结局指标
主要结局
The incidence of Grade 3 hypertension and atrial fibrillation
时间窗: at the end of 12 cycles of treatment（(each cycle is 28 days)
Number of patients with grade 3 or above hypertension during treatment/total number of patients enrolled; number of patients with atrial fibrillation during treatment/total number of patients enrolled.
次要结局
- ORR(at the end of 12 cycles of treatment(each cycle is 28 days))
- CR(at the end of 12 cycles of treatment(each cycle is 28 days))
- PFS(From the date of receipt of the first investigational medication to the date of first onset of disease progression or death from any cause, whichever comes first.up to 2 years)
- Improvement rate of abnormal indicators(After 12 cycles of treatment(each cycle is 28 days))
- OS(From the date of receipt of the first study medication to the date of death from any cause.up to 2 years)
- QoL(at the end of 12 cycles of treatment(each cycle is 28 days))
研究者
Wang Xin
Chief physician
Shandong Provincial Hospital
研究点 (1)
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