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临床试验/NCT04082286
NCT04082286已完成1 期

90Yttrium-labelled Anti-CD66 Monoclonal Antibody as Part of a Reduced Intensity Conditioning Regimen Prior to Allogeneic Haematopoietic Stem Cell Transplantation: an Open Label, Dose Escalating Phase I Study in Children and Adolescents With Relapsed/Refractory Leukaemia

Great Ormond Street Hospital for Children NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
9
试验地点
2
主要终点
maximum tolerated dose (MTD)

研究概览

简要总结

The radio-labeled anti-CD66 monoclonal antibody (with 111In for dosimetry and 90Y for therapy) will be administered in the T11 North room, UCLH, while the reduced intensity conditioning regimen and the allogeneic hematopoietic stem cell transplant will be performed in 2 centers, according to the age of the patient: A) patients aged < 13 years will be transplanted at the Bone Marrow Transplantation Department, Great Ormond Street Hospital (GOSH), and B) patients aged 13-18 years will be transplanted at the Bone Marrow Transplantation Department, University College London Hospitals (UCLH).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

Yttrium-90 labelled monoclonal antibody against CD66

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

maximum tolerated dose (MTD)

时间窗: 45 days post transplant

targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66

dose limited toxicity (DLT)

时间窗: 45 days post transplant

targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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