PDF(Pubmed)
Abstract：
BACKGROUND: Children and adolescents with mature B cell non-Hodgkin lymphoma (B-NHL) are treated with short-intensive chemotherapy. The burden of short-term and long-term toxicity is highly relative to its high cure rate in good-risk patients. Although the addition of rituximab to standard lymphome Malin B (LMB) chemotherapy markedly prolongs event-free survival and overall survival in high-risk patients, the benefit of rituximab in good-risk patients remains to be elucidated. This clinical trial will examine whether the addition of rituximab eliminates anthracyclines in good-risk patients without compromising treatment outcomes.
METHODS: We will perform a single-arm, open-label, multicentre phase II study. Low-risk (stage I - completely resected, stage II abdominal) and intermediate-risk (stages I and II - incompletely resected; stage II - resected, other than abdominal; stage III with LDH <2× upper limit of normal) patients with newly diagnosed B-NHL are eligible. Low-risk patients receive two courses of R-COM1P (rituximab, cyclophosphamide, vincristine, methotrexate, prednisolone and intrathecal methotrexate with hydrocortisone), and intermediate-risk patients receive COP (cyclophosphamide, vincristine, prednisolone and intrathecal methotrexate with hydrocortisone) followed by two courses each of R-COM3P and R-CYM (rituximab, cytarabine, methotrexate and intrathecal methotrexate with hydrocortisone). The primary endpoint is a 3-year event-free survival rate in paediatric patients (<18 years) with intermediate-risk disease. 100 patients (10 low-risk and 90 intermediate-risk) will enrol within a 4-year enrolment period and the follow-up period will be 3 years. 108 institutions are participating as of 1 January 2024 (64 university hospitals, 29 general hospitals, 12 children\'s hospitals and three cancer centres).
BACKGROUND: This research was approved by the Certified Review Board at NHO Nagoya Medical Center (Nagoya, Japan) on 21 September 2021. Written informed consent is obtained from all patients and/or their guardians. The results of this study will be disseminated through peer-reviewed publications and conference presentations.
BACKGROUND: Japan Registry of Clinical Trials, jRCTs041210104.
METHODS: We will perform a single-arm, open-label, multicentre phase II study. Low-risk (stage I - completely resected, stage II abdominal) and intermediate-risk (stages I and II - incompletely resected; stage II - resected, other than abdominal; stage III with LDH <2× upper limit of normal) patients with newly diagnosed B-NHL are eligible. Low-risk patients receive two courses of R-COM1P (rituximab, cyclophosphamide, vincristine, methotrexate, prednisolone and intrathecal methotrexate with hydrocortisone), and intermediate-risk patients receive COP (cyclophosphamide, vincristine, prednisolone and intrathecal methotrexate with hydrocortisone) followed by two courses each of R-COM3P and R-CYM (rituximab, cytarabine, methotrexate and intrathecal methotrexate with hydrocortisone). The primary endpoint is a 3-year event-free survival rate in paediatric patients (<18 years) with intermediate-risk disease. 100 patients (10 low-risk and 90 intermediate-risk) will enrol within a 4-year enrolment period and the follow-up period will be 3 years. 108 institutions are participating as of 1 January 2024 (64 university hospitals, 29 general hospitals, 12 children\'s hospitals and three cancer centres).
BACKGROUND: This research was approved by the Certified Review Board at NHO Nagoya Medical Center (Nagoya, Japan) on 21 September 2021. Written informed consent is obtained from all patients and/or their guardians. The results of this study will be disseminated through peer-reviewed publications and conference presentations.
BACKGROUND: Japan Registry of Clinical Trials, jRCTs041210104.
摘要：
背景：患有成熟B细胞非霍奇金淋巴瘤（B-NHL）的儿童和青少年接受短期强化化疗。短期和长期毒性的负担与其在高风险患者中的高治愈率高度相关。尽管利妥昔单抗添加到标准淋巴瘤MalinB（LMB）化疗可显着延长高危患者的无事件生存期和总生存期，利妥昔单抗在高危患者中的获益仍有待阐明.这项临床试验将检查利妥昔单抗的添加是否消除了高风险患者的蒽环类药物而不影响治疗结果。
方法：我们将执行单臂，开放标签，多中心II期研究。低风险(第一阶段-完全切除，II期腹部）和中危（I期和II期-不完全切除；II期-切除，除腹部外；LDH<2×正常上限的III期）新诊断的B-NHL患者符合条件。低风险患者接受两个疗程的R-COM1P（利妥昔单抗，环磷酰胺,长春新碱,甲氨蝶呤,泼尼松龙和鞘内甲氨蝶呤与氢化可的松），和中危患者接受COP(环磷酰胺，长春新碱,泼尼松龙和鞘内注射甲氨蝶呤和氢化可的松），然后分别进行两个疗程的R-COM3P和R-CYM（利妥昔单抗，阿糖胞苷,甲氨蝶呤和鞘内甲氨蝶呤与氢化可的松）。主要终点是患有中危疾病的儿科患者（<18岁）的3年无事件生存率。100名患者（10名低危和90名中危）将在4年内注册，随访期为3年。截至2024年1月1日，有108所机构参加(64所大学医院，29家综合医院，12家儿童医院和三个癌症中心)。
背景：这项研究获得了NHO名古屋医学中心认证审查委员会的批准（名古屋，日本）2021年9月21日。从所有患者和/或其监护人获得书面知情同意书。这项研究的结果将通过同行评审的出版物和会议演讲进行传播。
背景：日本临床试验注册中心，jRCTs041210104。
方法：我们将执行单臂，开放标签，多中心II期研究。低风险(第一阶段-完全切除，II期腹部）和中危（I期和II期-不完全切除；II期-切除，除腹部外；LDH<2×正常上限的III期）新诊断的B-NHL患者符合条件。低风险患者接受两个疗程的R-COM1P（利妥昔单抗，环磷酰胺,长春新碱,甲氨蝶呤,泼尼松龙和鞘内甲氨蝶呤与氢化可的松），和中危患者接受COP(环磷酰胺，长春新碱,泼尼松龙和鞘内注射甲氨蝶呤和氢化可的松），然后分别进行两个疗程的R-COM3P和R-CYM（利妥昔单抗，阿糖胞苷,甲氨蝶呤和鞘内甲氨蝶呤与氢化可的松）。主要终点是患有中危疾病的儿科患者（<18岁）的3年无事件生存率。100名患者（10名低危和90名中危）将在4年内注册，随访期为3年。截至2024年1月1日，有108所机构参加(64所大学医院，29家综合医院，12家儿童医院和三个癌症中心)。
背景：这项研究获得了NHO名古屋医学中心认证审查委员会的批准（名古屋，日本）2021年9月21日。从所有患者和/或其监护人获得书面知情同意书。这项研究的结果将通过同行评审的出版物和会议演讲进行传播。
背景：日本临床试验注册中心，jRCTs041210104。
