NCT02856464Unknown2 期
A Phase II Prospective Trial of Prophylactic Donor Lymphocyte Infusions for the Prevention of Relapse Post HSCT in Patients With High Risk Myeloid Malignancy
King's College Hospital NHS Trust2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2016年12月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Disease free survival
研究概览
简要总结
The trial will be conducted as a multicentre open label, randomised prospective phase II clinical trial in patients with high risk myeloid malignancies.
The primary objective is to evaluate whether prophylactic donor lymphocyte infusions (DLI) delivered as part of a planned schedule improves the disease free survival of patients with myeloid malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria
- •Haematological cancer which can be one of the following
- •Acute Myeloid Leukaemia (AML) if Intermediate or High risk in CR1
- •AML if favourable risk in CR2
- •Patients with AML or MDS with residual cytogenetic or molecular disease pre-HSCT
- •Myelodysplastic Syndrome (MDS) defined by an IPSS category int-1 or higher with <5% blasts at the time of randomisation following cyto-reduction if necessary
- •Secondary MDS or AML; defined as arising from antecedent haematological disease or secondary to prior chemotherapy.
- •Patients with sibling or 9/10 or 10/10 HLA matched unrelated donor
- •Patients receiving alemtuzumab based reduced intensity conditioned HSCT
- •Age >/=18 years
- •Able to comprehend and give informed consent
排除标准
- •Patients with >5% blasts at time of HSCT
- •Patients eligible for myeloablative (Bu/Cy of Cy/TBI) HSCT protocols
- •Patients with myelofibrosis
- •Patients with hypersensitivity to alemtuzumab, melphalan, fludarabine or busulphan
- •ECOG performance status > 2
- •Patients who are pregnant or lactating
结局指标
主要结局
Disease free survival
时间窗: One year
次要结局
未报告次要终点
研究者
研究点 (2)
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