EUCTR2016-003578-42-ES进行中（未招募）1 期
Phase I / II Clinical Trial, multicenter, open, of infusion of activated NK cells for the treatment of children, adolescents and young adults with sarcomas.
Antonio Pérez-Martínez0 个研究点目标入组 10 人开始时间: 2017年9月18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
- 10
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. Patients aged between 0 and 30 years diagnosed with malignant sarcoma, who continue to present detectable residual disease (based on imaging techniques) at the end of conventional treatment.
- •2. Lansky / Karnofsky Index> 60%.
- •3. Functional alteration of organs (liver, renal, respiratory) mild-moderate (<4), according to National Cancer Institute criteria (NCI CTCAE v4).
- •4. Left ventricular ejection fraction> 39%.
- •5. Adult subjects who have voluntarily signed informed consent prior to the first study intervention.
- •6. Minors whose legal representative / guardian has voluntarily signed informed consent prior to the first study intervention.
- •7. In the case of mature minors (12-17 years of age), in addition to the consent signed by the legal guardian, the child's consent will be obtained.
- •8. Women with reproductive capacity should have a negative pregnancy test at the time of inclusion and should be given access to highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method of contraceptive implantation , Injectable contraceptive, permanent intrauterine device, sexual abstinence or partner with vasectomy) during their participation in the study and within 30 days after the last visit.
- •9. Presence of a compatible haploident donor (parent or sibling).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Patients with a history of poor therapeutic compliance.
- •2. Patients who, after a psycho-social evaluation, are censored as unfit for the procedure:
- •Socio-familial situation that makes it impossible to participate correctly in the study.
- •Patients with emotional or psychological problems secondary to the disease such as posttraumatic stress disorder, phobias, delusions, psychosis, requiring specialist support.
- •Evaluation of family involvement in the patient's health.
- •Inability to understand test information.
- •3. Functional alteration of organs (severe hepatic, renal, respiratory) (4), according to the criteria of the National Cancer Institute (NCI CTCAE 4.3).
- •4. The contraindications, interactions, precautions for use and dose reductions indicated in the relevant technical data sheets should be considered.
- •5. Subjects who have been given other investigational drugs within 90 days prior to inclusion.
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