EUCTR2020-005239-53-IT进行中（未招募）1 期
PHASE III RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF MOSUNETUZUMAB IN COMBINATION WITH LENALIDOMIDE IN COMPARISON TO RITUXIMAB IN COMBINATION WITH LENALIDOMIDE IN PATIENTS WITH FOLLICULAR LYMPHOMA AFTER AT LEAST ONE LINE OF SYSTEMIC THERAPY -
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
- 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 (unless due to underlying lymphoma, per the investigator)
- •Normal laboratory values
- •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), mosunetuzumab and 12 months after the final dose of rituximab
- •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
- •Grade 3b FL
- •History of transformation of indolent 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
- •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 Day 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
相似试验
进行中（未招募）
1 期
A Study to Evaluate Efficacy and Safety of Mosunetuzumab in Combinationwith Lenalidomide in Comparison to Rituximab in Combination withLenalidomide with a Non-Randomized, Single Arm US Extension ofMosunetuzumab in Combination with Lenalidomide in Patients withFollicular LymphomaEUCTR2020-005239-53-DEF. Hoffman-La Roche Ltd.400
进行中（未招募）
1 期
A Study to Evaluate Efficacy and Safety of Mosunetuzumab in Combination with Lenalidomide in Comparison to Rituximab in Combination with Lenalidomide in Patients with Follicular LymphomaRelapsed/refractory follicular lymphomaMedDRA version: 21.0Level: PTClassification code 10016906Term: Follicle centre lymphoma, follicular grade I, II, III refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-005239-53-ESRoche Farma S. A. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd400
进行中（未招募）
3 期
A phase III study of RO7030816(mosunetuzumab) in patients with follicular lymphoma after at least one line of systemic therapyFOLLICULAR LYMPHOMA AFTER AT LEAST ONE LINE OF SYSTEMIC THERAPYJPRN-jRCT2041210051Enkhee Purev400
进行中（未招募）
1 期
A Study to Evaluate Efficacy and Safety of Mosunetuzumab in Combinationwith Lenalidomide in Comparison to Rituximab in Combination withLenalidomide with a Non-Randomized, Single Arm US Extension ofMosunetuzumab in Combination with Lenalidomide in Patients withFollicular LymphomaEUCTR2020-005239-53-PLF. Hoffman-La Roche Ltd.400
尚未招募
不适用
RANDOMIZED, MULTICENTER, PHASE III,OPEN-LABEL STUDY OF ALECTINIB VERSUSCRIZOTINIB IN TREATMENT-NAÏVE ANAPLASTICLYMPHOMA KINASE−POSITIVE ADVANCEDNON−SMALL CELL LUNG CANCER-C34 Malignant neoplasm of bronchus and lungMalignant neoplasm of bronchus and lungC34PER-064-14F. HOFFMANN-LA ROCHE LTD.,