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

Incyte Corporation0 个研究点目标入组 180 人开始时间: 2017年12月13日最近更新: 2024年7月8日

研究概览

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•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 72
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 108

•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.
•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.

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