A phase 1, multi-center, open-label, uncontrolled, dose-escalation trial to evaluate the safety of OPB-111077 in combination with bendamustine and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Otsuka Pharmaceutical Co., LTD.0 个研究点目标入组 45 人开始时间: 2019年6月6日最近更新: 2024年4月1日

试验速览

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•1) Patients age 20 to 80 years, inclusive (at time of informed consent)
•2) Patients with a definite diagnosis of DLBCL
•3) Patients who have received at least initial standard treatment
•4) Patients with measurable lesions (based on International Working Group [IWG] 2014 criteria)
•5) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
•Only for dose-expansion stage
•6) Patients who are pathologically diagnosed as CD20 positive lymphoma
•7) Patients who have a history of being treated with 1 to 5 regimens of previous chemotherapy for the underlying disease

•1.Patients who are candidates for autologous or allogeneic hematopoietic stem cell transplantation
•2.Patients who were refractory to initial standard treatment
•3.Patients who have a history of bendamustine administration and are intolerant to bendamustine
•4.Patients with central nervous system (CNS) involvement of lymphoma or with a history of CNS involvement of lymphoma
•5.Patients diagnosed with DLBCL transformed from low-grade B-cell non-Hodgkin's lymphoma (NHL)
•Only for dose-expansion stage
•6.Patients who have a history of rituximab administration and are intolerant to rituximab

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