EUCTR2017-001624-22-CZ进行中（未招募）1 期
A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kd Inhibitor, in Relapsed or Refractory Follicular Lymphoma (CITADEL-203) - CITADEL-203
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
- •Aged 18 years or older
- •Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) Grade 1, 2, and 3a.
- •Ineligible for hematopoietic stem cell transplant.
- •Must have been treated with at least 2 prior systemic therapies.
- •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 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
- •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 phosphatidylinositol 3-kinase (PI3K) d 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 the first
- •dose of study treatment.
- •Active graft-versus-host disease.
- •Hepatitis B (HBV) or hepatitis C (HCV) infection: Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if
- •they are negative for HBV-DNA; these subjects should be considered for prophylactic antiviral therapy. Subjects positive for anti-HCV antibody
- •will be eligible if they are negative for HCV-RNA.
研究者
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