EUCTR2021-003832-96-PL进行中（未招募）1 期
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 - ChIm-NB-P
Jagiellonian University Medical College0 个研究点目标入组 20 人开始时间: 2021年9月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of NBL according to international criteria (International Neuroblastoma Risk Group, INRG).
- •2. Patients 1-18 years of age with HR-NBL with primary refractory disease, disease progression or recurrence.
- •3. 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).
- •4. Life expectancy =6 months.
- •5. Obtaining the informed written consent of the patient and / or statutory representative for the treatment.
- •6. Female patients of childbearing potential must consent to the use of effective contraception; Breastfeeding patients must consent to the termination of breastfeeding.
- •7. Patients who have previously received immunotherapy with DB or other anti-GD2 specific antibodies may be eligible for this study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 28
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with toxicities of =3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders.
- •2. Patients with neurological toxicities of =2 CTCAE WHO grade.
- •3. Active life-threatening infection until stabilization of the patient's condition.
- •4. Pregnancy and / or lactation.
- •5. Sexually active patients who refuse to use an effective method of contraception.
- •6. Current treatment with experimental drugs or use of such treatment within 2 weeks before signing the informed consent to participate in the study.
- •7. Radiotherapy within 3 weeks prior to the start of the study.
- •8. Participation in another clinical trial within 6 months before signing the informed consent to participate in the trial (not applicable to clinical trials in 1st line of treatment in HR-NBL).
- •9. Lack of informed written consent to treatment.
研究者
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