EUCTR2015-002467-42-FR进行中（未招募）1 期
A phase Ib/II study evaluating the safety and efficacy of Atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma
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
- 38
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
- •Relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option exists as determined by the investigator
- •Histologically documented CD20-positive lymphoma as determined by the local laboratory
- •Fluorodeoxyglucose-avid lymphoma (i.e., PET-positive lymphoma)
- •At least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by CT scan or magnetic resonance imaging [MRI])
- •Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL
- •Agreement to comply with all local requirements of the lenalidomide risk minimization plan
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), and for at least 18 months after the last dose of study treatment
- •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm for at least 3 months after the last dose of study treatment.
- •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 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •Grade 3b follicular lymphoma
- •History of transformation of indolent disease to DLBCL
- •Known history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia or evidence of active pneumonitis at screening.
- •Known CD20-negative status at relapse or progression
- •Central nervous system lymphoma or leptomeningeal infiltration
- •Prior allogeneic stem-cell transplantation (SCT)
- •Completion of autologous SCT within 100 days prior to Day (D) 1 of Cycle (C) 1
- •Prior standard or investigational anti-cancer therapy as specified in protocol
- •History of resistance to lenalidomide or response duration of <1 year
- •Treatment with systemic immunosuppressive medications
- •History of solid organ transplantation
- •Clinically significant toxicity from prior therapy that has not resolved to Grade = 2 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.0) prior to Day 1 of Cycle 1
- •History of erythema multiforme, Grade = 3 rash, or blistering following prior treatment with immunomodulatory derivatives such as thalidomide and lenalidomide
- •Active bacterial, viral, fungal, or other infection or IV antibiotics within 4 weeks of Day 1 of Cycle 1
- •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 progressive multifocal leukoencephalopathy
- •History of autoimmune disease
- •Contraindication to treatment for thromboembolism prophylaxis
- •Grade = 2 neuropathy
- •History of other malignancy that could affect compliance with the protocol or interpretation of results
- •Evidence of any significant, uncontrolled concomitant disease
- •Inadequate hematologic function (unless due to underlying lymphoma)
- •Abnormal laboratory values (unless due to underlying lymphoma)
- •Pregnant or lactating or intending to become pregnant during the study
- •History of severe allergic or anaphylactic reaction to humanized, chimeric or murine monoclonal antibodies
- •Vaccination with a live virus vaccine within 28 days prior to Day 1 of Cycle 1
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