Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome in Outpatient Haploidentical Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cytokine Release Syndrome
研究概览
简要总结
Phase II, randomized controlled, unblinded clinical trial. Will evaluate whether the administration of oral cyclosporine started on day 0 of transplantation is effective in reducing the incidence of cytokine release syndrome (CRS) in patients who receive an outpatient haploidentical transplant.
详细描述
CRS is usually limited after the administration of post-transplant cyclosporine (PT-CsA) administered on days +3 and +4, however, there is no standard prevention or treatment regimen for CRS after haplo-TCPH and therapeutic behavior has usually been adopted.
Sample of 32 patients between the ages of 16 and 60 who receive their first haploidentical transplant at our center. In the control group, CsA 6 mg/kg orally divided into two doses per day starting in the morning on day +5 of the transplant, mycophenolic acid 1 gram orally (2 tablets of 500 mg) from day +5 post-transplant and post-transplant cyclophosphamide (PT-CY) at 50 mg/kg per day on days +3 and +4 and in the experimental group, CsA 6 mg/kg orally divided into two doses per day starting in the morning on day 0 after transplantation, mycophenolic acid 1 gram orally (2 tablets 500 mg) from day 0 post-transplant and PT-CY at 50 mg/kg per day on day +3 and +4.
Will document the presence of CRS and its degree, as well as the need for hospitalization, associated infectious processes, and a day to recover neutrophils and platelets. Additionally, 4 blood samples will be taken from the patients to determine the level of cytokines and C-reactive protein.
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
- 16 Years 至 60 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 16-60 years of age who receive their first haploidentical transplant.
排除标准
- •Patients positive for the human immunodeficiency virus (HIV), Hepatitis B or C virus
- •Pregnancy or lactation
- •Patients with documented infection at the time of transplantation
- •Presence of previous autoimmune diseases
- •Inability to tolerate the oral route
研究组 & 干预措施
Arm 1
Cyclosporine 6 mg/kg orally divided into two doses per day starting in the morning on day 0 after transplantation, mycophenolic acid 1 gram orally (2 tablets 500 mg) from day 0 post-transplant and PT-CY at 50 mg/kg per day on day +3 and +4.
干预措施: Cyclosporine (Drug)
结局指标
主要结局
Cytokine Release Syndrome
时间窗: day 0 to day 30
Presence of Fever, hypotension, hypoxemia
次要结局
未报告次要终点
研究者
David Gomez Almaguer
Chief of service
Hospital Universitario Dr. Jose E. Gonzalez
