Tocilizumab for Cytokine Release Syndrome Prophylaxis in Peripheral Blood Haploidentical Hematopoietic Stem Cell Transplantation With Post-transplant Cyclophosphamide
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cytokine release syndrome
研究概览
简要总结
Tocilizumab will be administered prior to transplantation in order to prevent the onset of cytokine release syndrome and its complications associated to peripheral blood haploidentical hematopoietic stem cell transplantation with post-transplant cyclophosphamide
详细描述
Cytokine release syndrome (CRS) is a common and potentially severe toxicity associated to haploidentical peripheral blood (PBSC) hematopoietic stem cell transplantation (Haplo-HSCT), which was described previously in the context of immunotherapies for acute lymphoblastic leukemia such as chimeric antigen receptor T-cells and blinatumomab.
CRS is characterized by immune system activation with a high level of circulating inflammatory cytokines including IL-6. Haplo-HSCT recipients have a high incidence of post-transplant fever, with elevated IL-6 in absence of documented infection. CRS occurs more frequently when using PBSC, and severe cases have been associated to delayed engraftment, increased transplant-related mortality and lower survival.
Tocilizumab an IL-6 receptor-targeted monoclonal antibody has been effectively used to treat CRS in several scenarios, including Haplo-HSCT. Therefore, there is considerable interest for the development of a successful strategy for CRS prevention with tocilizumab, potentially eliminating complications. However, it is currently unknown whether the use of this monoclonal antibody can adversely affect the outcome of Haplo-HSCT recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Haploidentical transplant recipients
- •Informed consent signature
- •Previous diagnosis of any neoplastic, metabolic or autoimmune disease
排除标准
- •History of immune deficiency virus infection
- •Hepatitis C or B virus infection
- •Documented bacterial of fungal infection prior to tocilizumab infusion
- •Previous use of tocilizumab
研究组 & 干预措施
Tocilizumab 4 mg/kg
Tocilizumab 4 mg/kg IV single dose day -1 prior to haploidentical transplantation
干预措施: Tocilizumab (Drug)
Tocilizumab 8 mg/kg
Tocilizumab 8 mg/kg IV single dose day -1 prior to haploidentical transplantation
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Cytokine release syndrome
时间窗: 1 week
Incidence of fever in the first seven days after haploidentical transplantation
次要结局
- Hospitalization rate(1 week)
- IL-6 concentration(1 week)
- Adverse effects(1 week)
研究者
David Gomez Almaguer
MD
Hospital Universitario Dr. Jose E. Gonzalez