EUCTR2015-001364-19-IT进行中（未招募）1 期
A phase Ib/II study evaluating the safety and efficacy of MPDL3280A in combination with either obinutuzumab plus bendamustine or obinutuzumab plus CHOP in patients with follicular lymphoma or diffuse large B-cell lymphoma - A PHASE IB/II STUDY EVALUATING THE SAFETY AND EFFICACY OF MPDL3280A IN COMBINATION WITH EITHER OBI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
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
- •Age >= 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
- •For patient enrolled in safety run-in phase: Relapsed or refractory follicular lymphoma after treatment with at least one prior
- •chemoimmunotherapy regimen or previously untreated Grade 1, 2, or 3a follicular lymphoma that requires treatment (as per Groupe d'Etudes des
- •Lymphomes Folliculaires (GELF) criteria)
- •For patient enrolled in expansion phase: Previously untreated Grade 1, 2, or 3a follicular lymphoma that requires treatment (as
- •per GELF criteria) or previously untreated advanced diffuse large B-cell lymphoma (DLBCL)
- •Histologically documented CD20-positive lymphoma
- •Fluorodeoxyglucose-avid lymphoma (i.e., positron emission tomography -positive lymphoma)
- •Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of
- •the diagnosis of FL or DLBCL
- •For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use contraceptive methods that result in a failure rate of <1% per year during the treatment
- •period and for at least 18 months after the last dose of study treatment.
- •For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 46
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •Histological evidence of transformation of follicular lymphoma into high-grade B-cell non-Hodgkin's lymphoma
- •Central nervous system lymphoma or leptomeningeal infiltration
- •For patients with relapsed or refractory FL (enrolled in the safety run-in
- •phase: Prior allogeneic or autologous stem cell transplantation; Prior anthracycline therapy
- •History of solid organ transplantation
- •History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies
- •Active bacterial, viral, fungal, or other infection
- •History of progressive multifocal leukoencephalopathy
- •Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening
- •Known history of HIV positive status
- •History of autoimmune disease
研究者
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