EUCTR2017-000970-12-FR进行中（未招募）1 期
A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kd Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor. - CITADEL-204
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Men and women, aged 18 or older
- •Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of = 1 lesion that measures > 1.5 cm in the longest transverse diameter (LDi) and = 1.0 cm in the longest perpendicular diameter as assessed by CT or magnetic resonance imaging (MRI).
- •-Subjects with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
- •Subjects must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 96
排除标准
- •Evidence of diffuse large B-cell transformation.
- •History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
- •Prior treatment with idelalisib, other selective PI3Kd inhibitors, or a pan-PI3K inhibitor.
- •Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
- •Active graft versus host disease.
- •Liver disease:
- •- Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation
研究者
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