JPRN-jRCT2041210051进行中（未招募）3 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 WITH A NON-RANDOMIZED, SINGLE ARM US EXTENSION OF MOSUNETUZUMAB IN COMBINATION WITH LENALIDOMIDE IN PATIENTS WITH FOLLICULAR LYMPHOMA AFTER AT LEAST ONE LINE OF SYSTEMIC THERAPY
Enkhee Purev0 个研究点目标入组 400 人开始时间: 2021年8月6日最近更新:
适应症
试验速览
- 阶段
- 3 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
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Any history of Grade 3b FL
- •-Any history of disease transformation and/or diffuse-large B cell lymphoma
- •-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 CNS lymphoma or leptomeningeal infiltration
- •-Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade -Treatment with systemic immunosuppressive medications, including, but not limited to prednisone (> 20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
- •-History of solid organ transplantation
- •-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 or suspected chronic active Epstein-Barr virus (EBV) infection
- •-Known or suspected history of hemophagocytic lymphohistiocytosis
- •-Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
- •-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, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, multiple sclerosis, vasculitis, or glomerulonephritis.
- •-Prior allogeneic stem cell transplantation
- •-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 (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
- •-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, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results
排除标准
- •- Any history of Grade 3b FL
- •- Any history of disease transformation and/or diffuse-large B cell lymphoma
- •- 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 CNS lymphoma or leptomeningeal infiltration
- •- Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade - Treatment with systemic immunosuppressive medications, including, but not limited to prednisone (> 20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
- •- History of solid organ transplantation
- •- 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 or suspected chronic active Epstein-Barr virus (EBV) infection
- •- Known or suspected history of hemophagocytic lymphohistiocytosis
- •- Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
- •- 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, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, multiple sclerosis, vasculitis, or glomerulonephritis
- •- Prior allogeneic stem cell transplantation
- •- 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 (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
- •- 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, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results
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）
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-ITF. HOFFMANN - LA ROCHE LTD.400
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.,