A Single-centre Study of Certican (Everolimus) as Prophylaxis for Graft-versus-Host Disease Following Post-Transplantation Cyclophosphamide After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Incidence of acute GvHD III-IV° until day +100 after allogenic stem cell transplantation
研究概览
简要总结
A phase II clinical study to assess the efficacy of short-term everolimus as prophylaxis for Graft-versus-Host disease (GvHD) in addition to post-transplantation cyclophosphamide after allogeneic hematopoietic stem cell transplantation in patients with haematological malignancies
详细描述
Title of the clinical study: A single-centre study of Certican (everolimus) as Prophylaxis for Graft-versus-Host Disease following Post-Transplantation Cyclophosphamide after Allogeneic Stem Cell Transplantation (OCTET-EVER)
Indication: Patients with haematological malignancies after allogeneic haematopoietic stem cell transplantation with a matched related or unrelated donor following reduced intensity conditioning and post-transplantation cyclophosphamide
Phase: Phase II clinical study
Type of study, study design, methodology: Single centre single arm clinical trial, A'Hern's single stage phase II procedure
Number of subjects: 20 (17 total evaluable)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with haematological malignancies after allogeneic haematopoietic stem cell transplantation with a matched related or unrelated donor following reduced intensity conditioning and post-transplantation cyclophosphamide
- •Principal inclusion criteria:
- •Written informed consent
排除标准
- •Known intolerance to everolimus
- •Presence or history of Microangiopathy
- •Presence of uncontrolled infections
- •Severe organ dysfunction defined as:
- •Cardiac left ventricular ejection fraction (LVEF) of less than 35%
- •Diffusing lung capacity (DLCO) of less than 40%
- •Total lung capacity (TLC) of less than 40%
- •Forced expiratory volume (FEV1) of less than 40%
- •Total bilirubin >3mg/dl
- •Creatinine-clearance of less than 40 ml/min
- •Pregnancy or breast feeding
- •Participation in other experimental drug trials
研究组 & 干预措施
Everolimus as part of GvHD prophylaxis after allogeneic SCT
Everolimus from day +5 to day +100
干预措施: Everolimus (Drug)
结局指标
主要结局
Incidence of acute GvHD III-IV° until day +100 after allogenic stem cell transplantation
时间窗: day 100 after transplantation
GvHD
次要结局
- Incidence of overall chronic GvHD(720 days after transplantation)
- Chimerism(day 100 after transplantation)
- Relapse incidence(720 days after transplantation)
- Non-relapse mortality(720 days after transplantation)
- Incidence of acute GvHD II-IV° until day +100 after allogenic stem cell transplantation(day 100 after transplantation)
- Incidence of severe chronic GvHD(720 days after transplantation)
- Overall survival(720 days after transplantation)
- Engraftment(day 100 after transplantation)
- Immune reconstitution(day 100 after transplantation)
研究者
Christoph Scheid
Prof. Dr. Christoph Scheid
University of Cologne