A Randomized, Open-label, Single-center Study Comparing Cyclophosphamide at a Dose of 25 mg/kg/Day and Cyclophosphamide at a Dose of 50 mg/kg/Day in Graft Versus Host Disease Prophylaxis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Incidence of acute graft-versus-host disease, grades II-IV
研究概览
简要总结
This is a two arm open label phase III clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from any donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity conditioning regimen of fludarabine, busulfan (treosulfan). Patients will receive PTCy at different dose (25 mg/kg/day vs 50 mg/kg/day on day +3,+4 in combination with calcineurin inhibitors and mofetil mycophenolate) as GvHD prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients who have an indication for allogeneic hematopoietic stem cell transplantation
排除标准
- •Uncontrolled bacterial or fungal infection at the time of enrollment
- •Requirement for vasopressor support at the time of enrollment
- •Karnofsky index <30%
- •Pregnancy
- •Somatic or psychiatric disorder making the patient unable to sign informed consent
研究组 & 干预措施
Cyclophosphamide on day +3,+4 at dose 50 mg/kg/day
Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.
干预措施: Post-transplantation Cyclophosphamide at dose 50 mg/kg/day (Drug)
Cyclophosphamide on day +3,+4 at dose 25 mg/kg/day
Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.
干预措施: Post-transplantation Cyclophosphamide at dose 25 mg/kg/day (Drug)
结局指标
主要结局
Incidence of acute graft-versus-host disease, grades II-IV
时间窗: 180 days
MAGIC criteria
Incidence of chronic GVHD, moderate and severe (NIH criteria)
时间窗: 365 days
NIH criteria
次要结局
- Non-relapse mortality analysis(365 days)
- Event-free survival analysis(365 days)
- Incidence of graft failure and poor graft function(365 days)
- Overall survival analysis(365 days)
- Incidence of 30-Day Readmission(365 days)
研究者
Mikhail Drokov
MD, PhD
National Research Center for Hematology, Russia