NCT04038359已完成2 期
A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma (iNHL)
SecuraBio28 个研究点 分布在 8 个国家目标入组 102 人开始时间: 2019年9月24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
- 102
- 试验地点
- 28
- 主要终点
- Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria
研究概览
简要总结
This study will examine the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.
详细描述
This is a Phase 2, randomized, open-label, 2-arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in subjects with R/R iNHL who have received at least 1 prior systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years, ECOG performance status ≤ 2
- •Histologically confirmed diagnosis of iNHL (Subtypes include FL Grades 1 to 3a, marginal zone lymphoma (splenic, nodal, or extranodal), or SLL
- •Must have received 1 prior systemic regimen for iNHL
- •Must have documented radiologic evidence of disease progression, at least 1 bi-dimensionally measurable lesion ≥ 1.5 cm (which has not been previously irradiated), according to 2007 revised IWG criteria, and be a candidate for a subsequent line of therapy.
- •Must have adequate organ function defined by the following laboratory parameters:
- •Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L
- •Platelet count ≥ 75 × 10^9/L
- •Hemoglobin ≥ 8 g/dL
- •Estimated creatinine clearance ≥ 60 mL/min, as determined by the Cockcroft-Gault method
- •Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (exception: subjects with Gilbert's Syndrome may have a bilirubin > 1.5 × ULN)
- •Aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum pyruvic transaminase (SGPT) ≤ 3.0 × ULN
排除标准
- •Anticancer treatment, major surgery, or use of any investigational drug within 28 days before the start of study intervention; palliative radiation therapy is allowed if > 7 days before planned first dose of study interventions, and any toxicity is Grade ≤ 1
- •Clinical or histological evidence of transformation to a more aggressive subtype of lymphoma or grade 3b FL or Richters' transformation or CLL
- •Prior allogeneic hematopoietic stem cell transplant (HSCT); prior treatment with a PI3K inhibitor
- •History of drug-induced colitis or pneumonitis; TB treatment ≤ 2 years prior to randomization; administration of a live or live attenuated vaccine within 6 weeks of randomization
- •Ongoing treatment with chronic immunosuppressants or systemic steroids or treatment for systemic bacterial, fungal, or viral infection
- •Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection
- •Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
- •Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start of study intervention.
- •Baseline QTcF > 500 ms
- •Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix, bladder cancer, or prostate cancer not requiring treatment. Subjects with previous malignancies are eligible if they have been disease-free for 2 years or more.
- •Unstable or severe uncontrolled medical condition that would, in the Investigator's judgment, increase the subject's risk to participating in this study.
研究组 & 干预措施
Duvelisib, Continuous and Intermittent Dosing
Experimental
Duvelisib 25 milligrams (mg) twice daily (BID) continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on for each subsequent 4-week cycle.
干预措施: Duvelisib (Drug)
Duvelisib, Intermittent Dosing
Experimental
Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.
干预措施: Duvelisib (Drug)
结局指标
主要结局
Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria
时间窗: Up to 14 months
ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and assessed using the 2007 revised IWG criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites.
次要结局
- Progression-free Survival (PFS)(Up to 2 years)
- ORR At Specific Timepoints(6, 12, 18, and 24 months after first dose of study intervention)
- Duration of Response (DOR)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Lymph Node Response Rate (LNRR)(14 months)
- Time To First Response (TTFR)(Up to 14 months)
- Time To Treatment Failure (TTF)(Up to 2 years)
- ORR According to 2014 Lugano Criteria(Up to 14 months)
研究者
研究点 (28)
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