Reduction of Acute and Chronic Graft-versus-host Disease After Allogeneic Hematopoietic Stem-cell Transplantation by Adapting Cyclosporine Doses According to Calcineurin Activity : a Proof-of-concept Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- The primary end point is the acute grade II to IV GVHD-free survival 100 days after transplantation.
研究概览
简要总结
The purpose of this trial is to assess whether an adaptation of cyclosporine (CsA) dose according to a longitudinal calcineurin (CN) activity monitoring would prevent the onset of graft-versus-host disease (GVHD).
详细描述
Our previous studies established a correlation between increased calcineurin (CN) activity and the risk of developing severe acute GVHD in allogeneic stem cell transplant recipients receiving immunosuppressive therapy with calcineurin inhibitors.
This proof-of-concept trial is aiming at evaluating CALCIneurin activity as a monitoring biomarker of efficacy of cyCLOsporine - (CALCICLO) - for the prophylaxis of acute GVHD. Our aim is to assess whether a longitudinal monitoring of CN activity would permit to adapt and optimize the dose of CsA that would prevent the onset of severe acute GVHD, yet still maintaining an acceptable tolerability profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were between the age of 12 and 60 years
- •Patients planned to receive an allogeneic HSCT following a myeloablative conditioning regimen
排除标准
- •Transplant from a syngeneic donor
- •Evidence of refractory disease
- •Nonmyeloablative conditioning
- •Any participation to a study with a new investigational drug within the previous 3 months
研究组 & 干预措施
Dose adjustment according CN activity
干预措施: Dose adaptation according to CN activity monitoring (Behavioral)
Dose adjustment according CN activity
干预措施: Cyclosporine (CsA) (Drug)
结局指标
主要结局
The primary end point is the acute grade II to IV GVHD-free survival 100 days after transplantation.
时间窗: 100 days after transplantation.
次要结局
- Safety was a secondary endpoint. It was assessed through clinical assessments including vital signs, creatinine clearance, the presence or not of neurological signs evocative of, or consistent with CsA toxicity, creatinine clearance and serum bilirubin.(100 days after transplantation)