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ATLG Levels in Autologous HSCT for Multiple Sclerosis (ATLG-MS)

2026年6月4日 更新者：Ciceri Fabio

ATLG Levels and Immune Reconstitution Kinetics in Autologous HSCT for Multiple Sclerosis

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

20

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 意大利
    • Italy
      • Milan、Italy、意大利、20132
        • 招聘中
        • IRCCS Ospedale San Raffaele
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study will involve 20 MS patients, treated with autologous HSCT as standard-of-care according to guidelines and consensus recommendations. Autologous HSCT is considered a standard-of-care intervention in the following selected MS patients: RRMS who have failed to respond to one or more high-efficacy DMTs or progressive MS with superimposed inflammatory activity, or aggressive forms of MS where rapid neurological decline occurs early in the disease course.

Patients will receive standard conditioning regimen (BEAM or cyclophosphamide) and ATLG (total dose 30 mg/kg over 3 days: 10 mg/kg on days -3, -2 and -1).

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Multiple Sclerosis patients treated with autologous HSCT as standard of care
The study will involve 20 Multiple Sclerosis (MS) patients, treated with autologous HSCT as standard-of-care according to guidelines and consensus recommendations. Autologous Hematopoietic stem cell transplantation (HSCT) is considered a standard-of-care intervention in the following selected MS patients: RRMS who have failed to respond to one or more high-efficacy Disease modifying therapies (DMTs) or progressive MS with superimposed inflammatory activity, or aggressive forms of MS where rapid neurological decline occurs early in the disease course.
药品：ATLG administration
Patients will receive standard conditioning regimen (BEAM or cyclophosphamide) and ATLG (total dose 30 mg/kg over 3 days: 10 mg/kg on days -3, -2 and -1).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Investigate immune status in correlation with ATLG
大体时间：before mobilization, before conditioning, +1/3/6/12 months after HSCT.
Longitudinal IR monitoring (T/B/NK lymphocyte subpopulations including naïve- memory- stem/memory- regulatory subsets, cytokine profile, NFL/Macrophages) on PB
before mobilization, before conditioning, +1/3/6/12 months after HSCT.
Investigate immune status in correlation with ATLG
大体时间：before and 30' after the end of ATLG dose, day0, day1, weekly for 4 weeks.
Assessment of ATLG levels & kinetics
before and 30' after the end of ATLG dose, day0, day1, weekly for 4 weeks.

次要结果测量

结果测量
措施说明
大体时间
Assess clinically relevant viral infections in correlation with viral specific IR
大体时间：before mobilization, +1 month after HSCT within the first year after HSCT.
Assessment of pathogen-specific responses (CMV specific T cells by ELISpot) and occurrence of clinically relevant viral infections (CMV, EBV; ECIL 10 guidelines).
before mobilization, +1 month after HSCT within the first year after HSCT.
To assess HSCT and neurological outcomes
大体时间：at 100 days and 1-year
Transplant-related mortality (TRM)
at 100 days and 1-year
Assessment of Progression Free Survival (PFS)
大体时间：at 1-year
Assessment of general HSCT outcomes (PFS)
at 1-year
Assessment of Overall survival (OS)
大体时间：At 1 year
Assessment of general HSCT outcomes - OS
At 1 year
neurological status- Expanded Disability Status Scale (EDSS)
大体时间：at 100 days, 6 months and 1-year
Expanded Disability Status Scale (EDSS)
at 100 days, 6 months and 1-year
neurological status - neurological progression
大体时间：at 1 year
neurological status - neurological progression
at 1 year
neurological status -No Evidence of Disease Activity
大体时间：At 1 year
No Evidence of Disease Activity (NEDA)
At 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ciceri Fabio

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月4日

初级完成 (估计的)

2028年5月4日

研究完成 (估计的)

2029年5月4日

研究注册日期

首次提交

2026年6月4日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年6月9日

上次提交的符合 QC 标准的更新

2026年6月4日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ATLG-MS
  • 4332 (其他标识符：Registro studi osservazionali)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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