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

INCYTE CORPORATIO0 个研究点目标入组 90 人开始时间: 2021年2月1日最近更新: 2021年4月5日

适应症

试验速览

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•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.
•- Subjects with splenic MZL who do not have a tumor to biopsy or an archival tumor tissue sample are eligible for participation provided subject is willing to undergo a bone marrow biopsy or provide an archival bone marrow biopsy that was obtained since
•completion of last therapy and within 2 years before the date of the first dose of study treatment;
•Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
•Full list of inclusion criteria is described in section 3.1 of Protocol
•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 18
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 72

•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
•Full list of exclusion criteria is described in section 3.2 of Protocol

发起方

INCYTE CORPORATIO