NCT04298879已完成2 期
A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
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
- 81
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
详细描述
Patients will be recruited for 2 cohorts. Cohort A will recruit 58 RRFL subjects, and Cohort B will recruit 62 RRMZL subjects.
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
- •Aged 18 years or older.
- •Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) Grade 1, 2, and 3a or MZL.
- •Ineligible for hematopoietic stem cell transplant.
- •Definition of RRFL or RRMZL: Subjects should have received 2 or more prior therapies for FL/MZL included at least one regimen containing Rituximab. Subjects should be refractory to Rituximab or experienced disease progression after achieved remission or disease progression within 6 months since last therapy.
- •Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
- •Subjects must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
- •ECOG performance status 0 to
- •Life expectancy ≥ 12 weeks.
- •Adequate hematologic, hepatic, and renal function.
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •1 . Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
- •History of central nervous system lymphoma (either primary or metastatic).
- •Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
- •Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
- •Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
- •Active graft-versus-host disease.
- •Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
研究组 & 干预措施
IBI376
Experimental
IBI376 will be administered orally at a dose of 20 mg once daily for 8 weeks followed by 2.5 mg once daily.
干预措施: IBI376 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 2 years
To assess the efficacy of IBI376 in terms of objective response rate (ORR) in subjects with relapsed or refractory follicular lymphoma (FL)/Marginal lymphoma(MZL). Subjects will be evaluated for ORR by an IRC (Lugano criteria)
次要结局
- Complete Response Rate (CRR)(2 years)
- Progression-free Survival (PFS)(2 years)
- Duration of Response (DOR)(2 years)
- Best percentage change in target lesion size(2 years)
- Overall Survival (OS)(2 years)
- Safety and tolerability of IBI376 measured by adverse events (AEs)(Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject)
研究者
研究点 (1)
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