A Phase 2, Open Label Study to Assess the Efficacy and Safety of Tenalisib (RP6530), a Novel PI3K Dual δ/γ Inhibitor, in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy.
详细描述
Tenalisib is a highly specific and orally available dual PI3K δ/γ inhibitor. Pre-clinical experiments demonstrated that Tenalisib is highly effective in killing primary CLL cells in vitro. A Phase II study is planned to evaluate the efficacy and safety of Tenalisib in patients with relapsed/refractory CLL.
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
盲法说明
None (open label)
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 with diagnosis of B-cell CLL
- •Disease status defined as refractory to or relapsed after at least one prior therapy.
- •Presence of measurable lymphadenopathy presence of > 1 nodal lesion
- •ECOG performance status ≤
- •Adequate bone marrow, liver, and renal function
排除标准
- •Richter's (large cell) transformation, or PLL transformation.
- •Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter).
- •Prior exposure to drug that inhibits PI3K
- •Patient with ASCT/Allo-SCT receiving treatment for active GVHD.
- •Ongoing severe systemic bacterial, fungal or viral infection.
- •Central nervous system (CNS) involvement of leukemia or lymphoma.
- •Ongoing immunosuppressive therapy including systemic corticosteroids.
- •Known history of severe liver injury as judge by investigator.
- •Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation
- •Women who are pregnant or lactating.
- •Known seropositive requiring anti-viral therapy for i. human immunodeficiency virus (HIV) infection. ii. hepatitis B virus (HBV) infection iii. hepatitis c virus (HCV) infection iv. active CMV infection
研究组 & 干预措施
Tenalisib
Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles
干预措施: Tenalisib (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 7 Months
Per Response Evaluation Criteria as defined by iwCLL guideline for CLL: Complete Response (CR), all parameters should be regressed to normal (lymph nodes ≥ 1.5 cm; spleen size \<13 cm; liver size normal; no constitutional symptoms; circulating lymphocyte count normal; platelet count ≥ 100 x 109 /L; Hemoglobin ≥ 11.0 g/dL). For partial response, at least two of the parameters (lymph nodes, liver and/or spleen size, constitutional symptoms, circulating lymphocyte count) and one parameter (platelet count, hemoglobin) need to improve if previously abnormal; Overall Response (OR) = CR + PR."
Duration of Response (DoR)
时间窗: 7 Months
Duration of response (DOR): DOR is defined as the interval from the first documentation of CR/PR to the first documentation of definitive disease progression or death from any cause. Progression disease is defined using iwCLL criteria as at least one of the criteria of parameters (i.e., lymph nodes increase ≥ 50% from baseline or from response; liver and/or spleen size increase ≥ 50% from baseline or from response; any constitutional symptoms; circulating lymphocyte count increase ≥ 50% over baseline) or criteria of parameters (i.e., platelet count decrease of ≥ 50% over baseline secondary to CLL; hemoglobin decrease of ≥ 50% over baseline secondary to CLL) should be met.
次要结局
- Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0(7 Months)
- Progression Free Survival (PFS)(7 months)