Haploidentical Hematopoietic Cell Transplantation Combined With an Unrelated Cord Blood Unit for Acute T Cell Lymphoblastic Leukemia Compared to Haploidentical Hematopoietic Cell Transplantation: a Multicenter, Randomized, Open-label Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are:
Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL.
Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute T cell lymphoblastic leukemia
- •With available minimal residual disease parameters assessed by flow cytometry and/or quantitative polymerase chain reaction
- •Willing to undergo haploidentical hematopoietic cell transplantation and having a suitable haploidentical donor
- •With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- •Signing an informed consent form, having the ability to comply with study and follow-up procedures
排除标准
- •With other malignancies
- •Failing to acquire a suitable unrelated cord blood unit
- •With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy
- •With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation
- •With severe organ dysfunction
- •In pregnancy or lactation period
- •With any conditions not suitable for the trial (investigators' decision)
结局指标
主要结局
Progression-free survival
时间窗: 2 years after randomization
estimated progression-free survival at 2 year
次要结局
- Adverse events(2 years after randomization)
- Cumulative incidence of relapse(2 years after randomization)
- Overall survival(2 years after randomization)
- Non-relapse mortality(2 years after randomization)