NCT02998476已完成2 期
A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 70
- 主要终点
- Objective Response Rate Based on Lugano Classification Criteria in Group A
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Eligible 19 years and older in South Korea
- •Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior treatment regimens and ineligible for high-dose chemotherapy supported by autologous stem cell transplant.
- •Must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable extranodal lesion (≥1 cm in longest dimension) on computed tomography (CT) scan or magnetic resonance imaging (MRI).
- •Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
- •Eastern Cooperative Oncology Group performance status 0 to 2.
排除标准
- •Primary mediastinal (thymic) large B-cell lymphoma.
- •Known brain or central nervous system metastases or history of uncontrolled seizures.
- •Allogeneic stem cell transplant within the last 6 months, or active graft versus host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months.
- •Use or expected use during the study of any prohibited medications, including potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study drug.
- •Prior treatment with the following:
- •Group A: Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) δ inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg, ibrutinib).
- •Group B: Prior treatment with a selective PI3Kδ inhibitor (eg, idelalisib) or a pan PI3K inhibitor.
研究组 & 干预措施
Group A Parsaclisib (no prior BTK inhibitor)
Experimental
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
干预措施: Parsaclisib (Drug)
Group B Parsaclisib (prior BTK inhibitor)
Experimental
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
干预措施: Parsaclisib (Drug)
结局指标
主要结局
Objective Response Rate Based on Lugano Classification Criteria in Group A
时间窗: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.
次要结局
- Progression-free Survival in Group A(Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months)
- Overall Survival (OS) in Group A(From first dose of study drug until death by any cause; up to 26 months)
- Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B(Screening through 35 days after end of treatment, up to 42 months)
- Duration of Response in Group A(Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months)
研究者
研究点 (70)
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