NCT04324879Unknown2 期
A Open-label, Single-arm, Multicenter Phase Ⅱ Clinical Trial of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 41
- 主要终点
- Objective response rate (ORR) assessed by Independent Review Committee (IRC)
研究概览
简要总结
The objective of this study is to evaluate the efficacy of TQ-B3525 in patients with relapsed / refractory follicular 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
- •Understood and signed an informed consent form.
- •18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
- •Relapsed / refractory FL.
- •At least one measurable lymph node or extranodal lymphoma lesions.
- •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 diagnosed and/or treated additional malignancy within 3 years prior to the first administration.
- •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
- •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 received surgery, or unhealed wounds within 4 weeks before the first administration.
- •Has a history of autologous hematopoietic stem cell transplant within 3 months or allogeneic hematopoietic stem cell transplant within 6 months.
- •10.Has cardiovascular disease ≥grade 2 within 6 months before the first administration.
- •Has active hepatitis B or C.
- •Has psychotropic substances abuse or a mental disorder. 13.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: Baseline up to 18 months
Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
次要结局
- Progression-free survival (PFS)(Baseline up to 18 months)
- Overall response rate (ORR) assessed by investigator(Baseline up to 18 months)
- Disease control rate（DCR）(Baseline up to 18 months)
- Overall Survival (OS)(Baseline up to 24 months)
- Disease control rate (DOR)(Baseline up to 18 months)
- Safety(Baseline up to 18 months)
- Biomarkers(Baseline up to 18 months)
研究者
研究点 (41)
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