Immunotherapy with dinutuximab beta in combination with chemotherapy for the treatment of patients with primary neuroblastoma refractory to standard therapy and with relapsed or progressive disease.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- number of cycles aborted due to toxicity
研究概览
简要总结
The primary objective of the study is to evaluate the safety profile of 20 patients receiving dinutuximab beta in combination with chemotherapy compared to historical data from two reference groups:
- group 1 for patients treated with chemotherapy without immunotherapy
- group 2 for patients treated with immunotherapy without chemotherapy in patients with relapsed or progressive or primary resistance to treatment. The reference groups will consist of 2 groups of 10 patients who meet the inclusion criteria for the target group, but are treated only with chemotherapy (reference group 1) or only with immunotherapy (reference group 2) at the Department of Pediatric Oncology and Hematology in Krakow.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of NBL according to international criteria (International Neuroblastoma Risk Group, INRG).
- •Patients 1-18 years of age with HR-NBL with primary refractory disease, disease progression or recurrence.
- •Adequate function of vital organs (if abnormal, dysfunction below grade 4 according to the CTC AE WHO classification, except for disorders defined in the exclusion criteria).
- •Life expectancy ≥6 months.
排除标准
- •Patients with toxicities of ≥3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders.
- •Patients with neurological toxicities of ≥2 CTCAE WHO grade.
- •Active life-threatening infection until stabilization of the patient's condition.
- •Pregnancy and / or lactation
- •Radiotherapy within 3 weeks prior to the start of the study.
结局指标
主要结局
number of cycles aborted due to toxicity
number of cycles aborted due to toxicity
number of cycles in which treatment interruptions due to the occurrence of side effects will be longer than provided for in the treatment protocol
number of cycles in which treatment interruptions due to the occurrence of side effects will be longer than provided for in the treatment protocol
number of episodes of Capillary Leak Syndrome, regardless of severity
number of episodes of Capillary Leak Syndrome, regardless of severity
number of episodes of cytokine release syndrome, regardless of severity
number of episodes of cytokine release syndrome, regardless of severity
number of episodes of allergic reactions in CTCAE grade 3 and 4 (version in force at that time)
number of episodes of allergic reactions in CTCAE grade 3 and 4 (version in force at that time)
number of hematological toxicities in grade 3 and 4 CTCAE (version in force at that time)
number of hematological toxicities in grade 3 and 4 CTCAE (version in force at that time)
Number of neurological toxicity episodes, regardless of severity
Number of neurological toxicity episodes, regardless of severity
the percentage of patients with pupil disorders and / or visual disturbances
the percentage of patients with pupil disorders and / or visual disturbances
proportion of patients with renal or hepatic impairment in CTCAE grade 3 and 4 (version in force at that time)
proportion of patients with renal or hepatic impairment in CTCAE grade 3 and 4 (version in force at that time)
Other side effects in grade 3 and 4 CTCAE (version in force at the time)
Other side effects in grade 3 and 4 CTCAE (version in force at the time)
次要结局
未报告次要终点
研究者
prof. Walentyna Balwierz
Scientific
Uniwersytet Jagiellonski Collegium Medicum