一项在患有复发/难治性成熟 B 细胞非霍奇金淋巴瘤的儿童和青年参与者中评估 Glofitamab + 化学免疫疗法的研究 (iMATRIX GLO)
一项 I/II 期、开放标签、单臂、两部分试验，以评估 Glofitamab 联合化学免疫疗法在复发/难治性成熟 B- 儿科和年轻成人参与者中的安全性、耐受性、药代动力学和抗肿瘤活性细胞非霍奇金淋巴瘤
The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric and young adult participants with relapsed and refractory (R/R) mature B-cell non-Hodgkin lymphoma (B-NHL).
研究概览
地位
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名：Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
研究联系人备份
- 姓名：Reference Study ID Number: CO43810 https://forpatients.roche.com/ No attachments to email below.
- 电话号码：888-662-6728
- 邮箱：global-roche-genentech-trials@gene.com
学习地点
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Chengdu、中国、610041
- 招聘中
- West China Second University Hospital
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Guangzhou、中国、510060
- 招聘中
- Sun Yet-sen University Cancer Center
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Nanning、中国、530201
- 招聘中
- Guangxi Cancer Hospital of Guangxi Medical University
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København Ø、丹麦、2100
- 招聘中
- Rigshospitalet
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Budapest、匈牙利、1097
- 招聘中
- Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika
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Paraná
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Curitiba、Paraná、巴西、81520-060
- 招聘中
- Hospital Erasto Gaertner
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São Paulo
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São Paulo、São Paulo、巴西、04023-062
- 招聘中
- Graacc-Grupo de Apoio ao adolescente e a crianca com cancer
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Münster、德国、48149
- 招聘中
- Universitaetsklinikum Muenster
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Lazio
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Rome、Lazio、意大利、00165
- 招聘中
- IRCCS Ospedale Pediatrico Bambino Gesù
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Piedmont
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Turin、Piedmont、意大利、10126
- 招聘中
- Ospedaliera Ospedale Infantile Regina Margherita
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Prague、捷克语、150 06
- 招聘中
- Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie
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Bordeaux、法国、33076
- 招聘中
- Hôpital Pellegrin
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Villejuif、法国、94800
- 招聘中
- Gustave Roussy
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Wroclaw、波兰、50-556
- 招聘中
- Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu
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Queensland
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South Brisbane、Queensland、澳大利亚、4101
- 招聘中
- Queensland Children?s Hospital
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Western Australia
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Nedlands、Western Australia、澳大利亚、6009
- 招聘中
- Perth Children's Hospital
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Alabama
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Birmingham、Alabama、美国、35233
- 招聘中
- Children's Hospital of Alabama
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California
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Oakland、California、美国、94609
- 招聘中
- UCSF Benioff Children's Hospital Oakland
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Oakland、California、美国、94611
- 招聘中
- Kaiser Permanente Oakland Medical Center
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Roseville、California、美国、95661
- 招聘中
- Kaiser Permanente - Roseville
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Santa Clara、California、美国、95051
- 招聘中
- Kaiser Permanente - Santa Clara
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Maryland
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Baltimore、Maryland、美国、21231
- 招聘中
- Johns Hopkins University
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Massachusetts
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Boston、Massachusetts、美国、02215
- 招聘中
- Dana-Farber Cancer Institute
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Missouri
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Kansas City、Missouri、美国、64108
- 招聘中
- Childrens Mercy Hosp & Clinics
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New York
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New York、New York、美国、10065
- 招聘中
- MSKCC
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Ohio
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Cincinnati、Ohio、美国、45229
- 招聘中
- Cincinnati Children's Hospital Medical Center
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Barcelona、西班牙、08035
- 招聘中
- Hospital Universitari Vall d'Hebron
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Madrid、西班牙、28009
- 招聘中
- Hospital Infantil Universitario Niño Jesus
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Seoul、韩国、05505
- 招聘中
- Asan Medical Center
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Seoul、韩国、03080
- 招聘中
- Seoul National University Hospital- Pediatric Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 6 months to < 18 years at the time of signing Informed Consent for Cohort A Part 1 and Cohort B of the study, and age 6 months to < 30 years old at the time of signing Informed Consent for Cohort A Part 2 of the study
- Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate, pleural effusion, or ascites, prior to study entry of aggressive mature B-NHL that expresses CD20 (reconfirmed by IHC or flow cytometry if IHC is not possible), including BL, BAL (mature B-cell leukemia FAB L3), DLBCL, and PMBCL, at the time of first R/R disease for Cohort A and second or greater R/R disease for Cohort B
- Refractory or relapsed disease (i.e., prior treatment was ineffective or intolerable) following first-line standard-of-care chemoimmunotherapy for Cohort A and following at least two prior systemic chemoimmunotherapy regimens and who have exhausted all available established therapies for Cohort B
- Measurable disease, defined as: At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension; or percentage of bone marrow involvement with lymphoma cells defined by cytomorphological analysis of bone marrow aspirates
- Adequate performance status, as assessed according to the Lansky or Karnofsky Performance Status scales: Participants < 16 years old: Lansky Performance Status ≥ 50%; Participants ≥ 16 years old: Karnofsky Performance Status ≥ 50%
- Adequate bone marrow, liver, and renal function
- Negative test results for acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV)
- Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months
- Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment
- Participants and/or caregivers who are willing and able to complete clinical outcome assessments throughout the study using either paper or interviewer methods
Exclusion Criteria:
- Isolated CNS disease of mature B-NHL without systemic involvement, and primary CNS lymphoma
- Receipt of glofitamab prior to study enrollment
- Ongoing adverse events from prior anti-cancer therapy that were not resolved to Grade ≤ 1 (exceptions: alopecia, Grade 2 peripheral neuropathy)
- Grade ≥ 3 adverse events, with the exception of Grade 3 endocrinopathy managed with replacement therapy
- Participants with active infections which are not resolved prior to Day 1 of Cycle 1
- Prior solid organ transplantation
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH), or chronic active Epstein-Barr viral infection (CAEBV)
- Active autoimmune disease requiring treatment
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products, except if the participant was able to safely receive it after initial administration (consider consultation with Medical Monitor)
- History of confirmed progressive multifocal leukoencephalopathy
- Current or past history of uncontrolled non-malignant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
- Major surgery or significant traumatic injury < 28 days prior to the obinutuzumab pretreatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
- Administration of a live, attenuated vaccine within 4 weeks before the start of study treatment (obinutuzumab pretreatment) or at any time during the study treatment period and within 12 months after end of study treatment
- Participants with any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Arm A
Participants will receive glofitamab + R-ICE chemoimmunotherapy for up to 3 cycles (cycle length = 21 days). |
Participants will receive intravenous (IV) obinutuzumab pretreatment on Days 1 and 2 of Cycle 1 (Cycle length = 21 days) Arm A: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of Cycles 2 and 3 Arm B: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of each cycle thereafter (Cycle length = 21 days) Participants will receive IV rituximab on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days) Participants will receive IV ifosfamide on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days) Participants will receive IV carboplatin on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days) Participants will receive IV etoposide on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days) Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events |
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实验性的：Arm B
Participants will receive glofitamab monotherapy for up to 12 cycles (cycle length = 21 days). |
Participants will receive intravenous (IV) obinutuzumab pretreatment on Days 1 and 2 of Cycle 1 (Cycle length = 21 days) Arm A: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of Cycles 2 and 3 Arm B: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of each cycle thereafter (Cycle length = 21 days) Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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根据儿科参与者的国际儿科 NHL 反应标准和年轻成人参与者的卢加诺分类（A 组），研究者确定达到完全反应 (CR)
大体时间：最多 3 个治疗周期（周期长度 = 21 天）
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最多 3 个治疗周期（周期长度 = 21 天）
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Glofitamab 联合 R-ICE 化学免疫疗法的血清浓度（A 组）
大体时间：最多 3 个治疗周期（周期长度 = 21 天）
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最多 3 个治疗周期（周期长度 = 21 天）
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Glofitamab 单药治疗的血清浓度（B 组）
大体时间：最多 12 个治疗周期（B 组）（周期长度 = 21 天）
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最多 12 个治疗周期（B 组）（周期长度 = 21 天）
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发生不良事件 (AE) 的参与者百分比（A 组）
大体时间：约3年
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约3年
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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客观缓解率 (ORR)（A 组和 B 组）
大体时间：最多 3 个（A 组）或 12 个（B 组）治疗周期（周期长度 = 21 天）
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最多 3 个（A 组）或 12 个（B 组）治疗周期（周期长度 = 21 天）
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在最多三个治疗周期后进行 HSCT 的参与者百分比（A 组）
大体时间：最多 3 个治疗周期（周期长度 = 21 天）
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最多 3 个治疗周期（周期长度 = 21 天）
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Obinutuzumab 的血清浓度（A 和 B 组）
大体时间：最多 3 个（A 组）或 12 个（B 组）治疗周期（周期长度 = 21 天）
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最多 3 个（A 组）或 12 个（B 组）治疗周期（周期长度 = 21 天）
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利妥昔单抗的血清浓度（A 组）
大体时间：最多 3 个治疗周期（周期长度 = 21 天）
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最多 3 个治疗周期（周期长度 = 21 天）
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具有抗药物抗体 (ADA) 的参与者百分比（A 组和 B 组）
大体时间：最多 3 个治疗周期（周期长度 = 21 天）
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最多 3 个治疗周期（周期长度 = 21 天）
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完全缓解持续时间 (DOCR)（A 组）
大体时间：从第一次出现有记录的完全缓解 (CR) 到有记录的疾病进展或任何原因导致的死亡（以先发生者为准）（大约 3 年）
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从第一次出现有记录的完全缓解 (CR) 到有记录的疾病进展或任何原因导致的死亡（以先发生者为准）（大约 3 年）
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无进展生存期 (PFS)（A 组）
大体时间：从入组到首次出现疾病进展或任何原因导致的死亡（以先发生者为准）（约 3 年）
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从入组到首次出现疾病进展或任何原因导致的死亡（以先发生者为准）（约 3 年）
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无事件生存 (EFS)（A 组）
大体时间：从入组到首次出现疾病进展、全因死亡或开始新的抗淋巴瘤治疗（不包括计划的造血干细胞移植 (HSCT)）（约 3 年）
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从入组到首次出现疾病进展、全因死亡或开始新的抗淋巴瘤治疗（不包括计划的造血干细胞移植 (HSCT)）（约 3 年）
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缓解持续时间 (DOR)（B 组）
大体时间：从第一次出现有记录的 CR 或部分反应 (PR) 到有记录的疾病进展或任何原因导致的死亡，以先发生者为准（大约 4 年）
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从第一次出现有记录的 CR 或部分反应 (PR) 到有记录的疾病进展或任何原因导致的死亡，以先发生者为准（大约 4 年）
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出现不良事件的参与者百分比（B 组）
大体时间：约3年
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约3年
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总生存期 (OS)（A 组和 B 组）
大体时间：从入组到因任何原因死亡之日（A 组 = 约 3 年，B 组 = 约 4 年）
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从入组到因任何原因死亡之日（A 组 = 约 3 年，B 组 = 约 4 年）
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合作者和调查者
调查人员
- 研究主任：Clinical Trials、Hoffmann-LaRoche
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CO43810
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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