NCT03719534已完成3 期
An Open-label, Multicenter, Randomized, Phase 3 Trial to Assess the Efficacy and Safety of Coinfusion With Unrelated Cord Blood Unit for Patients With Acute Myeloid Leukemia Undergoing Haploidentical Hematopoietic Cell Transplantation
The First Affiliated Hospital of Soochow University5 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2017年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 5
- 主要终点
- Overall survival
研究概览
简要总结
Patients who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic cell transplantation (haplo HCT) are potential candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an coinfusion of an unrelated cord blood unit (haplo-cord HCT) in addition to Arm A. Progression-free survival, overall survival, cumulative incidence of relapse and nonrelapse mortality will be recorded as endpoints.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 60 years old;
- •Patients with AML;
- •With available minimal residual disease (MRD) parameters assessed by flow cytometry (FCM) and/or quantitative real-time PCR (qPCR)
- •Having no available HLA-matched donor, and willing to undergo haplo-HCT and having a suitable haploidentical donor
- •With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- •Signing informed consent form, having the ability to comply with study and follow-up procedures
排除标准
- •Acute promyelocytic leukaemia (AML subtype M3)
- •With other malignances
- •Failing to acquire a suitable UCB unit
- •With previous history of autologous haematopoietic cell transplantation (auto-HCT), allogeneic haematopoietic cell transplantation (allo-HCT) or chimaeric antigen receptor T-cell therapy
- •With uncontrolled infection intolerant to haplo-HCT
- •With severe organ dysfunction
- •Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
- •Respiratory failure (PaO2≤60 mmHg)
- •Hepatic abnormalities (total bilirubin≥2×upper limit of normal [ULN], alanine aminotransferase or aspartate aminotransferase≥2×ULN)
- •Renal dysfunction (creatinine≥2 mg/dL creatinine clearance rate < 30 mL/min)
- •In pregnancy or lactation period
- •With any conditions not suitable for the trial (investigators' decision)
结局指标
主要结局
Overall survival
时间窗: 3 year after randomization
estimated overall survival at 3 year
次要结局
- Progression-free survival(3 year after randomization)
- Cumulative incidence of non-relapse mortality(3 year after randomization)
- Cumulative incidence of relapse(3 year after randomization)
研究者
研究点 (5)
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