EUCTR2013-000015-24-GB进行中（未招募）1 期
90-Yttrium-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 with relapsed/refractory leukaemia - 90Y-antiCD66 monoclonal ab in childhood relapsed/refractory leukaemia
Great Ormond Street Hospital0 个研究点目标入组 24 人开始时间: 2020年6月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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
- •Patients must meet all of the following criteria for admission in the study:
- •1)An underlying haematological malignancy including:
- •a) isolated bone marrow relapse of AML after allogeneic haematopoietic stem cell transplantation;
- •b) isolated bone marrow relapse of ALL after allogeneic haematopoietic stem cell transplantation;
- •c) bone marrow relapse of JMML after allogeneic haematopoietic stem cell transplantation;
- •d) refractory AML (5-20% blasts in BM) with/without expression of CD66 on blasts;
- •e) refractory ALL (5-20% blasts in BM) with/without expression of CD66 on blasts;
- •f) refractory AML (> 20% blasts in BM) with expression of CD66 on blasts;
- •g) refractory ALL (> 20% blasts in BM) with expression of CD66 on blasts;
- •2) be ? 1 year old and ? 18 years old;
- •3) 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;
- •4) have a Karnofsky Performance Status ? 50 or Lansky Performance Status ? 30;
- •5) provide signed, written informed consent from parent or guardian;
- •6) be able to comply with study procedures and follow-up examinations;
- •7) have normal cardiac function without specific treatment;
- •8) have adequate organ function (as indicated by Table 3, chapter 5), within 30 days prior to 111In infusion;
- •9) 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;
- •10) be negative for human-anti-murine antibodies (HAMA).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients who meet any of the following criteria will be excluded from study admission:
- •1)patients with CNS disease;
- •2)patients with BM cellularity < 10%;
- •3)patients with refractory disease (? 20% blasts in BM) with no expression of CD66 on blasts;
- •4)patients with positive human-anti-murine antibodies;
- •5)patients with compromised organ function (as indicated by Table 3, chapter 5), within 30 days prior to 111In infusion;
- •6)patients with chronic extensive 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.
研究者
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