ATLG Levels in Autologous HSCT for Multiple Sclerosis
Key facts
- Where
- Milan, ItalySee the site
Where in Italy
- IRCCS Ospedale San RaffaeleMilan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ciceri Fabio
- Trial code
- NCT07635693
- Record updated
- 9 June 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Contraindications to HSCT procedures (including pregnancy and breast feeding, uncontrolled active infections); Subjects that did not accept to sign the informed consent; Use of ATG.