NCT04808570终止1 期
A Single-arm, Open-label, Multi-center Phase Ib/II Study of TQ-B3525 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma(CLL/SLL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 9
- 主要终点
- Overall response rate (ORR) assessed by Independent Review Committee
研究概览
简要总结
This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Understood and signed an informed consent form;
- •18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 2, Life expectancy ≥ 3 months; 3.Chronic lymphocytic leukemia/small lymphocytic lymphoma diagnosed by flow cytometry or pathology, and meets at least one of the criteria for active diseases requiring treatment in IWCLL2008; 4.Has received at least one line of previous treatment, the latest treatment confirmed no objective response, or disease progress after treatment; 5.Has at least one measurable lesion;
- •Adequate organ system function;
- •Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
排除标准
- •Has Richter's transformation or prolymphocytic leukemia (PLL)；
- •Has central nervous system violation;
- •Has uncontrolled primary autoimmune cytopenias, including autoimmune hemolytic anemia (AIHA), idiopathic thrombocytopenic purpura (ITP), etc；
- •Has received other PI3K inhibitors or CAR-T treatments;
- •Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 6.Diagnosed as type I diabetes or uncontrollable type II diabetes, or fasting blood glucose> 8.9 mmol/L or glycosylated hemoglobin (HbA1c)> 8.5% during the screening period;
- •Has interstitial lung disease or drug-induced interstitial lung disease history;
- •Has a history of immunodeficiency diseases;
- •Has multiple factors affecting oral medication;
- •Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1;
- •Has received systemic steroid treatment within 7 days before the first administration;
- •Has received other systemic anti-tumor medications within 4 weeks before the first administration, or still within the 5 half-life of the medication, which occurs first; 13.Has active infections within 4 weeks before the first administration; 14.Has received surgery, or unhealed wounds within 4 weeks before the first administration;
- •Has a history of autologous hematopoietic stem cell transplant within 3 months;
- •Has a history of allogeneic hematopoietic stem cell transplant;
- •Grade II or higher cardiovascular disease within 6 months before the first administration; 18.QTCF > 480ms, LVEF < 50%; 19.Urinary protein ≥ 2 +, and 24-hour urinary protein quantity>1g within 7 days;
- •Has active hepatitis B or C;
- •Has psychotropic substances abuse or a mental disorder;
- •Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
- •Has psychotropic substances abuse or a mental disorder;
研究组 & 干预措施
TQ-B3525 tablets
Experimental
TQ-B3525 tablet administered orally.
干预措施: TQ-B3525 tablets (Drug)
结局指标
主要结局
Overall response rate (ORR) assessed by Independent Review Committee
时间窗: Baseline up to 18 months
Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC
次要结局
- Duration of disease remission (DOR)(Baseline up to 18 months)
- Overall response rate (ORR) assessed by Investigator(Baseline up to 18 months)
- Progression-free survival (PFS)(Baseline up to 18 months)
- Disease control rate（DCR）(Baseline up to 18 months)
- Overall Survival (OS)(Baseline up to 24 months)
- Incidence of Adverse Events, Serious Adverse Events(Baseline up to 18 months)
研究者
研究点 (9)
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