ATLG Levels in Autologous HSCT for Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCiceri Fabio
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- ATLG administration
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Ciceri Fabio
Lead sponsor
IRCCS San Raffaele
Sponsor institution
Source ClinicalTrials.gov