NCT06574698招募中不适用
Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma: A Prospective, Single-Arm Clinical Study
Guangzhou Women and Children's Medical Center1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年5月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The number of the patients of VGPR or CR at the end of induction therapy
研究概览
简要总结
To explore the efficacy of adding anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy for newly diagnosed high risk neuroblastoma patients. To investigate wether anding Naxitamab in the induction phase will improve the response rate at the end of induction therapy and further improve the overall survival rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neuroblastoma patients who meet certain criteria are eligible for enrollment in the following stages of diagnosis:
- •Children with newly diagnosed stage 4 neuroblastoma according to the International Neuroblastoma Staging System (INSS) who meet the following criteria are eligible for enrollment: i. Age > 18 months (> 547 days) regardless of biological characteristics; or ii. Age 12-18 months (365-547 days), with one of the following three unfavorable biological characteristics (MYCN amplification, pathological type of poor histopathological prognosis, and/or DNA index = 1); or iii. MYCN amplification (MYCN signal increase > 4 times compared to reference signal) regardless of age or other biological characteristics.
- •Children with newly diagnosed stage 3 INSS neuroblastoma who meet the following criteria are eligible for enrollment: i. MYCN amplification (MYCN signal increase > 4 times compared to reference signal) regardless of age or other biological characteristics; or ii. Age > 18 months (> 547 days), with pathological type of poor histopathological prognosis regardless of MYCN status.
- •Children with newly diagnosed stage 2A/2B INSS neuroblastoma with MYCN amplification (MYCN signal increase > 4 times compared to reference signal) regardless of age or other biological characteristics. The subject must be aged ≤ 21 years at the time of initial diagnosis, and must be aged > 12 months at the time of enrollment.
- •Exclusion criteria:
- •Infants less than 1 year old, those aged 12-18 months, INSS stage 4, and all INSS stage 3 patients with favorable biological characteristics (i.e., non-amplified MYCN, good pathological histopathological prognosis, and DNA index >1) are not eligible.
- •Subjects who have received immunosuppressive treatment (excluding local steroids) within the last 4 weeks prior to enrollment. Subjects who are currently receiving any investigational drug.
- •Any other medical condition that, in the opinion of the investigator, may interfere with the interpretation of results or affect the subject's ability to provide informed consent, the legal guardian's ability to provide informed consent, and the subject's cooperation and participation in the study, including but not limited to malabsorption syndrome, mental illness, or substance abuse. Subjects with significant comorbidities (any serious medical condition unrelated to cancer or its treatment that is not covered by the detailed exclusion criteria and is expected to interfere with the investigation drug(s) action or significantly increase the severity of the trial treatment toxicity)
排除标准
- 未提供
研究组 & 干预措施
High risk Neuroblastoma
High risk Neuroblastoma
干预措施: Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy (Drug)
结局指标
主要结局
The number of the patients of VGPR or CR at the end of induction therapy
时间窗: 5 years
Measured by cross-sectional computed tomography (CT) or magnetic resonance imaging (MRI) imaging and/or by methyl iodobenzylguanidine (MIBG) or positron emission tomography (PET) scans and bone marrow (BM) responses, evaluated according to the 1993 International Neuroblastoma Response Criteria (INRC), and compared with relevant historical control groups.
次要结局
- Objective Response Rate (ORR)(5 years)
- The number of days a patient survives(3 years after the last patient was enrolled)
- The objective response rate (ORR) after 6 cycles of treatment.(5 years)
- The number of patients with adverse events related to treatment(5 years)
- The number of days the patient survive without relapse or progression(3 years after the last patient was enrolled)
研究者
Tianyou Yang
Chief Surgeon of Pediatric surgical oncology
Guangzhou Women and Children's Medical Center
研究点 (1)
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