NCT07635693招募中不适用
ATLG Levels and Immune Reconstitution Kinetics in Autologous HSCT for Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Ciceri Fabio
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
This is a prospective, observational, biological, multicenter study to investigate IR profile, ATLG dynamics, main HSCT and disease outcomes in MS. This study will provide a preliminary descriptive evaluation of key study parameters, including ATLG pharmacokinetics and immune reconstitution trends, as well as an initial assessment of variability (e.g., dispersion of immunological biomarkers), to support the interpretation of results and the design of future studies. Since this is an observational study, no clinical decision will be made, and the interim analysis will not have an impact of the study conduction, and it will not be a stopping rule.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Participant is willing and able to give informed consent for participation in the study.
- •Adult patients (age >/= 18y)
- •Diagnosis of MS
- •Confirmed program of autologous HSCT according to standard EBMT indications (any conditioning regimen considered standard, BEAM or Cyclophosphamide)
- •ATLG (total dose 30 mg/kg over 3 days: 10 mg/kg on days -3, -2 and -1) in the conditioning regimen.
排除标准
- •Subjects that did not accept to sign the informed consent.
- •Use of ATG.
- •Contraindications to HSCT procedures (including pregnancy and breast feeding, uncontrolled active infections)
研究者
研究点 (1)
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