NCT03711578已完成2 期
An Open Label, Phase II Study to Evaluate the Efficacy and Safety of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor in Adult Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL)
Rhizen Pharmaceuticals SA11 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2018年11月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 11
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
To assess the anti-tumor activity and safety of Tenalisib in patients with relapsed/refractory indolent Non-Hodgkin's Lymphoma (iNHL),
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 with histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to:
- •Follicular lymphoma (FL) G1, G2, or G3a
- •Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
- •Lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia (LPL/WM)
- •Small lymphocytic lymphoma (SLL) with absolute lymphocyte count <5 x10^9/L at the time of diagnosis and at study entry.
- •Relapsed or refractory after ≥ 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have received rituximab and alkylating agents.
- •Patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) with the longest diameter ≥ 1.5 cm.
- •Male or female patients > 18 years of age.
- •ECOG performance status ≤
- •Life expectancy of at least 3 months.
- •Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before starting study treatment:
- •Hemoglobin ≥ 9 g/dl
- •Absolute neutrophil count (ANC) ≥ 1 x 10^9/L
- •Platelets ≥50 x 10^9/L (patient without BM involvement) and 30 x 10^9/L (patient with BM involvement)
- •Total bilirubin ≤1.5 times the upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN if known liver involvement
- •Creatinine ≤ 1.5 mg/dL OR calculated creatinine clearance ≥ 50 mL/min (as calculated by the Cockcroft-Gault method)
- •Use of an effective means of contraception for female patients of child-bearing potential, and all male partners.
- •Willingness and ability to comply with trial and follow-up procedures, give written informed consent.
排除标准
- •FL grade 3b or transformed disease or CLL
- •Cancer therapy within 3 weeks (21 days) or 5 half-lives (whichever is shorter) prior to C1D
- •Corticosteroids (prednisone or equivalent) at a dose of < 20 mg daily are allowed. Corticosteroid should be stabilized for at least 1 week prior to C1D1
- •Auto-SCT within 3 months from C1D1 (patients must not have active graft versus- host disease)
- •History of having received an Allo-SCT
- •Active hepatitis B or C infection
- •Known history of human immunodeficiency virus (HIV) infection
- •Evidence of ongoing severe systemic bacterial, fungal or viral infection
- •Known primary central nervous system lymphoma or any preexisting neurologic manifestations
- •Known history of drug-induced liver injury, alcoholic liver disease, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension;
- •Prior exposure to drug that specifically inhibits PI3K
- •Pregnancy or lactation
- •Myeloid growth factors or red blood cells/ platelet transfusion within 14 days prior to C1D1
- •Drug administration within 1 week prior to C1D1
- •Strong inhibitors or inducers of CYP3A4, CYP2C9, including grapefruit products, herbal supplements and drugs
- •Substrates of CYP3A4 enzyme with a narrow therapeutic range
研究组 & 干预措施
Tenalisib
Experimental
Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles
干预措施: Tenalisib, (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 7 months
ORR is defined as sum of CR and PR rates and will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of Non-Hodgkin lymphoma. (Cheson-2014)
Complete Response Rate
时间窗: 7 months
CR rate will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of non-Hodgkin lymphoma.
Progression Free Survival (PFS)
时间窗: From date of first dose of tenalisib until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months
PFS is defined as the time of the first dose of Tenalisib to disease progression or death.
Duration of Response (DoR)
时间窗: 7 months
DoR is measured from the initial response to disease progression or death
次要结局
- Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v4.0(8 months)
研究者
研究点 (11)
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