EUCTR2017-003148-19-ES进行中（未招募）1 期
A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kd Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor. - CITADEL-205
适应症
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
- 性别
- All
入选标准
- •Subjects with pathologically confirmed MCL, with documentation of either overexpression of cyclin D1 or t(11;14), who have had at least 1 but no more than 3 prior systemic treatment regimens.
- •Men and women, aged 18 or older
- •Documented failure to achieve at least PR with or documented disease progression after the most recent treatment regimen.
- •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 CT or magnetic resonance imaging (MRI).
- •Eastern Cooperative Oncology Group (ECOG) performance status of = 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 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 72
排除标准
- •History of central nervous system lymphoma (either primary or metastatic).
- •Prior treatment with idelalisib, other selective phosphoinositide 3-kinase (PI3K) d 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 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: HBV DNA and HCV RNA must be undetectable. Subjects cannot be positive for hepatitis B surface antigen or anti–hepatitis B core antibody.
研究者
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