HIGH-DOSE IMMUNOSUPPRESSION WITH THIOTEPA AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE SCLEROSIS - ND

Phase 1

• Conditions: PATIENTS AFFECTED BY MULTIPLE SCLEROSIS; MedDRA version: 6.1Level: HLTClassification code 10052785

• Registration Number: EUCTR2007-000586-38-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-10
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

·multiple sclerosis defined by Mc Donald criteria;
·age between 18 and 55;
·EDSS score between 2 and 6.5;
·RR or SP clinical course;
·ability to give written informed consent;
·treatment failure to second line therapy (i.d. Natalizumab, Mitoxantrone or Cyclophosfamide). Failure treatment is defined by the occurrence, after at least three-six months of therapy, of the following:
a)at least one relapse or a documented rapid progression (progression is defined by an increase of at least 1 point at EDSS scale between 2.0 and 5.5 or 0,5 point between 5.5-6.5 over six months)
b)an increase of at least two T2 lesions or the presence of at least one new enhancing lesion at MRI performed six months after the previous one.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·previous treatment with TBI or TLI;
·treatment with interferons, Glatiramer acetate in 30 days before the ASCT;
·treatments with steroids, Cyclophosphamide, Mitoxantrone, Azathioprine, plasma-exchange, immunoglobulins in 30 days before phase I;
·impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit);
·impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x upper normal limit);
·left ventricular ejection < 50%;
·any other clinical, laboratory, instrumental abnormality that, on investigator?s opinion, could negatively affect the outcome of the treatment·recurrent or chronical infections;
·pregnancy, breast feeding, patient?s non compliance to use valid birth control methods;
·controindications for serial MRI (claustrophobia, metallic prothesis, cardiac pacemaker, tremor, spinal devices).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified