NCT06981988尚未招募1 期
A Study to Explore the Dosage and Efficacy of Linperlisib in Combination With Rituximab and to Validate the Efficacy of Linperlisib in Patients With Relapsed/Refractory Indolent NHL
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- MTD （Maximum tolerated dose）of Linperlisib（Stage 1）
研究概览
简要总结
The study is being conducted to evaluate the reasonable dosage, efficacy and safety of Linperlisib in combination with rituximab in subjects with relapsed/refractory (R/R) indolent non-hodgkin lymphoma(NHL) in adults.
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
- •Patients received at least 1 lines of systemic therapy
- •Previously received anti- CD20 treatment
- •Subjects must have at least one bi-dimensionally measurable lesion (nodal site Ldi > 1.5 cm or extranodal site Ldi > 1.0cm)
- •Patients must have an acceptable organ function
排除标准
- •Previously treated with PI3K inhibitors
- •Unresolved toxicity of CTCAE grade > 1 from prior anti-lymphoma therapy
- •Chemotherapy or other antitumor therapy within 14 days before starting cycle one
- •Significant concurrent medical disease or condition which according to the investigators' judgement
- •Active hepatitis B, C or HIV infection
- •Infection requiring treatment 2 weeks prior to the first dosing
研究组 & 干预措施
Linperlisib + Rituximab
Experimental
干预措施: Linperlisib ； Rituximab (Drug)
结局指标
主要结局
MTD （Maximum tolerated dose）of Linperlisib（Stage 1）
时间窗: Subjects are evaluated for DLTs during the first 28-day cycle
RP2/3D（Recommended Phase II/III Dose) of Linperlisib （Stage 1）
时间窗: The RP2/3D for Phase 2/3 will be selected at the end of Phase 1b, approximately 2 years
Complete response rate (CRR) assessed by Investigator（Stage 2）
时间窗: up to 5 years
Progression-free Survival assessed by Investigator （Stage 2）
时间窗: up to 5 years
次要结局
- Objective Response Rate (ORR) assessed by Investigator(up to 5 years)
- Duration of response (DOR) assessed by Investigator(up to 5 years)
- Incidence of Adverse Events (Linperlisib when combined with Rituximab)(up to 5 years)
研究者
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