NCT04398953Unknown2 期
A Single-arm, Multicenter Phase II Clinical Trial of TQ-B3525 Tablet in the Treatment of Relapsed / Refractory Mantle Cell Lymphoma (MCL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 102
- 试验地点
- 39
- 主要终点
- Objective response rate (ORR) assessed by Independent Review Committee (IRC)
研究概览
简要总结
This is a study to evaluate the safety and efficacy of TQ-B3525 tablets in patients with relapsed / refractory mantle cell lymphoma (MCL).
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
- •Understood and signed an informed consent form;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥ 3 months;
- •Relapsed / refractory MCL;
- •Has received at least one-line and less than four lines of previous treatment, the latest treatment confirmed no objective response, or disease progress after treatment;
- •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 central nervous system violation;
- •Has received other PI3K inhibitors;
- •Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration;
- •Has history of interstitial lung disease;
- •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;
- •Has palliative radiation therapy within 4 weeks before the first administration;
- •Has active infections within 4 weeks before the first administration;
- •Has received surgery, or unhealed wounds within 4 weeks before the first administration;
- •Has a history of autologous hematopoietic stem cell transplant within 6 months or allogeneic hematopoietic stem cell transplant;
- •QTCF > 480ms, LVEF < 50%;
- •Urinary protein ≥ 2 +, and urinary protein quantity >1.0 g in 24 hours 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.
研究组 & 干预措施
TQ-B3525 tablet
Experimental
TQ-B3525 tablet administered orally.
干预措施: TQ-B3525 (Drug)
结局指标
主要结局
Objective response rate (ORR) assessed by Independent Review Committee (IRC)
时间窗: up to 12 months
Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator.
次要结局
- Progression-free survival (PFS)(up to 12 months)
- Biomarkers(up to 12 months)
- Duration of Response (DOR)(up to 12 months)
- Overall survival (OS)(up to 18 months)
- Disease control rate（DCR）(up to 12 months)
研究者
研究点 (39)
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