跳至主要内容
临床试验/NCT04781803
NCT04781803Unknown2 期

Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome in Outpatient Haploidentical Hematopoietic Stem Cell Transplantation

Hospital Universitario Dr. Jose E. Gonzalez1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年3月25日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

发起方
Hospital Universitario Dr. Jose E. Gonzalez
申办方类型
Other
责任方
Principal Investigator
主要研究者

David Gomez Almaguer

Chief of service

Hospital Universitario Dr. Jose E. Gonzalez

研究点 (1)

Loading locations...

相似试验