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).
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Investigate immune status in correlation with ATLG — 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
Investigate immune status in correlation with ATLG — before and 30' after the end of ATLG dose, day0, day1, weekly for 4 weeks. Assessment of ATLG levels \& kinetics
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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