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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 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
- 否
入选标准
- •An underlying haematological malignancy including:
- •isolated bone marrow relapse of AML after allogeneic haematopoietic stem cell transplantation;
- •isolated bone marrow relapse of ALL after allogeneic haematopoietic stem cell transplantation;
- •bone marrow relapse of JMML after allogeneic haematopoietic stem cell transplantation;
- •refractory AML (5-20% blasts in BM) with/without expression of CD66 on blasts;
- •refractory ALL (5-20% blasts in BM) with/without expression of CD66 on blasts;
- •refractory AML (> 20% blasts in BM) with expression of CD66 on blasts;
- •refractory ALL (> 20% blasts in BM) with expression of CD66 on blasts;
- •be ≥ 1 year old and ≤ 18 years old;
- •must not be eligible for therapy of higher curative potential. Where an alternative therapy has been shown to prolong survival in an analogous population, this should be offered to the patient prior to discussing this study;
- •have a Karnofsky Performance Status ≥ 50 or Lansky Performance Status ≥ 30;
- •provide signed, written informed consent from parent or guardian;
- •be able to comply with study procedures and follow-up examinations;
- •have normal cardiac function without specific treatment;
- •have adequate organ function (as indicated by Table 3, chapter 5), within 30 days prior to 111In infusion;
- •patients who have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrolment;
- •be negative for human-anti-murine antibodies (HAMA).
排除标准
- •patients with CNS disease; 2) patients with BM cellularity < 10%; 3) patients with ≥ 20% blasts in BM and no expression of CD66 on blasts; 4) patients who are positive for human-anti-murine antibodies (HAMA); 5) patients with compromised organ function (as indicated by Table 3, chapter 5), within 30 days prior to 111In infusion; 6) patients with extensive chronic GvHD; 7) patients with an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment; 8) patients who are pregnant or lactating; 9) patients with any other severe concurrent disease, which, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
研究组 & 干预措施
Radioimmunotherapy
Children affected by high risk malignant disorders will be receiving increasing infused activity of a radio-immune conjugated antibody as part of their conditioning regimen prior to alleogeneic stem cell transplantation
干预措施: Yttrium-90 labelled monoclonal antibody against CD66 (Other)
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