ATLG Levels in Autologous HSCT for Multiple Sclerosis
Recruiting · NCT07635693 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ciceri Fabio
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
Where it is running
1 location listed.
- IRCCS Ospedale San Raffaele - Milan, Italy, Italy