A Comparative Study of Haploidentical Transplantation Supported by Third-party Cord Blood and Haploidentical Transplantation in Hematological Malignancies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
The objective of this study was to explore whether the combination with umbilical cord blood (UCB) is associated with superior disease-free survival (DFS) in the setting of haploidentical donors (HID) transplantation.
详细描述
The main causes of allogeneic hematopoietic stem cell transplantation (allo-HSCT) failure are primary disease relapse and transplant-related complications, especially relapse. In recent years, with the development of transplantation technology, alternative donors such as HID and UCB have been widely used. But, these alternative donors are associated with high incidences of transplant-related complications and mortalities when compared with human leukocyte antigen (HLA)-matched donors. Some studies suggeted that mixed grafts might overcome the disadvantages of a single alternative graft. UCB transplant (UCBT) supported by third-party HID or HID transplants supported by third-party UCB has been reported to have rapid engraftment and low incidences of graft-versus-host-disease (GVHD), making survival improvement. However, most of these results came from single-arm studies. The comparative studies between haplo-PBSC+Cord and haplo-PBSC+BM are scarce in the setting of HID transplantation. In a retrospective study, the investigators found haplo-PBSC+Cord transplantation has superior DFS than haplo-PBSC+BM in hematological malignancies. To further confirmed this conclusion, the investigators plan to conduct a prospective, multicenter, phase 3 randomized controlled trial.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hematologic malignancies undergoing first HID allo-HSCT
- •Age 18 to 65 years old with ECOG performance status 0-2
- •Received myeloablative conditioning regimens
- •Sign informed consent form, have the ability to comply with study and follow-up procedures
排除标准
- •Received PBSCs as only grafts
- •Acute leukemia transformed from a myeloproliferative tumor
- •Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
- •Respiratory failure ( PaO2 ≤60mmHg)
- •Hepatic abnormalities (total bilirubin ≥3 mg/dL, aminotransferase >2 times the upper limit of normal)
- •Renal dysfunction (creatinine clearance rate < 30 mL/min)
- •ECOG performance status 3, 4 or 5
- •With any conditions not suitable for the trial (investigators' decision)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 1 year
次要结局
- Overall survival (OS)(1 year)
- The cumulative incidence of chronic GVHD(1 year)
- Relapse rate(1 year)
- The cumulative incidence of acute graft-versus-host-disease (GVHD)(100 days post-transplantation)
- The cumulative incidence of hematopoietic engraftment.(30 days post-transplantation)
研究者
Liu Qifa
Professor
Nanfang Hospital, Southern Medical University