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.
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。