EUCTR2020-005239-53-PL进行中（未招募）1 期
PHASE III RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATINGEFFICACY AND SAFETY OF MOSUNETUZUMAB IN COMBINATION WITHLENALIDOMIDE IN COMPARISON TO RITUXIMAB IN COMBINATION WITHLENALIDOMIDE WITH A NON-RANDOMIZED, SINGLE ARM US EXTENSIONOF MOSUNETUZUMAB IN COMBINATION WITH LENALIDOMIDE INPATIENTS WITH FOLLICULAR LYMPHOMA AFTER AT LEAST ONE LINE OFSYSTEMIC THERAPY
F. Hoffman-La Roche Ltd.0 个研究点目标入组 400 人开始时间: 2021年9月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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 at the time of signing Informed Consent Form
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- •Histologically documented CD20 + follicular lymphoma (FL) (Grades 1-3a)
- •Requiring systemic therapy assessed by investigator based on tumor size and/or Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
- •Received at least one prior systemic lymphoma therapy, which included prior immunotherapy or chemoimmunotherapy
- •Availability of a representative tumor specimen and the corresponding pathology report at the time of relapse/persistence for confirmation of the diagnosis of FL
- •Adequate hematologic function without growth factors or blood product
- •transfusion within 14 days of first dose of study drug administration (unless due to underlying lymphoma, per the investigator)
- •Normal laboratory values
- •Negative HIV test at screening
- •Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program
- •Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use 2 adequate methods of contraception during the treatment period (including periods of treatment interruption), and for at least 28 days after the final dose of lenalidomide, 3 months after the final dose of tocilizumab (if applicable), mosunetuzumab, and 12 months after the final dose of rituximab
- •Men must agree to remain abstinent (refrain from heterosexual
- •intercourse) or use contraceptive measures and agreement to refrain
- •from donating sperm during the treatment period and for at least 28
- •days after the final dose of lenalidomide, 3 months after the final dose of
- •tocilizumab (if applicable) and 12 months after the final dose of
- •For patients enrolled in the extended China enrollment phase at National Medical Products Administration (NMPA)-recognized sites: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
- •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 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Any history of Grade 3b FL
- •Any history of disease transformation and/or disease to diffuse large B-cell lymphoma (DLBCL)
- •Documented refractoriness to lenalidomide, defined as no response (partial response or complete response) or relapse within 6 months of therapy
- •Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid
- •antigen test result is also acceptable
- •Active or history of central nervous system (CNS) lymphoma or leptomeningeal infiltration
- •Prior standard or investigational anti-cancer therapy
- •Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade <=1 (per National Cancer Institute Common Toxicity Criteria for Adverse Events Version 5.0 [NCI CTCAE, v5.0]) prior to Day 1 of Cycle 1
- •Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
- •History of solid organ transplantation
- •History of severe allergic or anaphylactic reaction to humanized, chimeric or murine MAbs
- •Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the mosunetuzumab, lenalidomide, or thalidomide formulation, including mannitol
- •History of erythema multiforme, Grade >=3 rash, or blistering following prior treatment with immunomodulatory derivatives
- •History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune pneumonitis
- •Known active bacterial, viral, fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1
- •Known or suspected chronic active Epstein-Barr virus (EBV) infection
- •Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- •Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
- •Active Hepatitis B or C infection
- •Known history of human immunodeficiency virus (HIV) positive status
- •History of progressive multifocal leukoencephalopathy (PML)
- •Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study
- •Other malignancy that could affect compliance with the protocol or interpretation of results
- •Active autoimmune disease requiring treatment
- •History of autoimmune disease
- •Prior allogeneic stem cell transplant (SCT)
- •Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to, significant cardiovascular disease or significant pulmonary disease
- •Major surgical procedure other than for diagnosis within 28 days prior to
- •Day 1 of Cycle 1 or anticipation of a major surgical procedure during the
- •course of the study
- •Pregnant or lactating or intending to become pregnant during the study
- •Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator’s judgment
研究者
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