ATLG Levels During Autologous Stem Cell Transplant for MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter, observational study will describe ATLG dynamics and immune reconstitution in people with MS receiving autologous HSCT. It will collect biological data to describe ATLG pharmacokinetics and related immune changes, providing baseline variability and trends to inform future research. No clinical decisions will be made within the study, and interim analyses will not influence study conduct or stopping rules. The study aims to generate descriptive findings rather than to determine treatment efficacy. Data will come from standard EBMT-indicated conditioning regimens including BEAM or Cyclophosphamide.

Why it matters

Who can join: the full rules

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's running

• IRCCS Ospedale San Raffaele
  Milan, Italy, Italy Recruiting

Study contacts

• Study coordinator: Raffaella Greco
• Email: greco.raffaella@hsr.it
• Phone: +39 02-2643-3903

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.