A multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis. - StarMS

Sheffield Teaching Hospitals0 sites198 target enrollmentFebruary 3, 2020

Overview

No summary available.

Registry

who.int

Start Date

February 3, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Sheffield Teaching Hospitals

•1\. Diagnosis of MS using the 2017 McDonald criteria.
•2\. Age 16\-55 inclusive.
•3\. EDSS 0\-6\.0 inclusive\*. If the EDSS score is 6\.0 this must be due to confirmed relapse rather than progressive disease.
•4\. Severe inflammatory disease defined as RRMS course with 2 or more protocol defined relapses, or 1 such relapse and evidence of MRI disease activity \>3 months before or after its onset, in last 12 months despite being on a DMT\*.
•5\. Clinical stability for \>30 days following last relapse at the time of screening.
•6\. Satisfactory EBMT Autoimmune Disease Working Party (ADWP) recommended screening assessment prior to aHSCT.
•7\. Participants who have been reviewed by the central neurology team and confirmed as eligible.
•8\. Participants who, in the opinion of the local haematology lead or delegate, are fit enough to undergo treatment.
•9\. Able to undergo MRI examination.
•\* Patients with EDSS scores of 0\-1\.5 or those who failed only first line treatments must also fulfil following criteria: short illness duration (\<5 years), active disease clinically and radiologically (i.e. at least 2 relapses in the last 12 months and evidence of multiple Gad enhancing MRI lesion), high brain lesion load and brain or spinal cord atrophy.

•1\. Diagnosis of primary or secondary progressive MS.
•2\. Disease duration of \>10 years from symptom onset (note: symptoms must be clearly attributable to MS).
•3\. Previous use of alemtuzumab, ocrelizumab or cladribine.
•4\. Previous HSCT for any reason, or any previous experimental or commercial stem cell therapy.
•5\. JCV antibody Index of \>1\.5 in patients previously treated with natalizumab (unless they are CSF JCV PCR negative).
•6\. Prior diagnosis of Hepatitis B, Hepatitis C or HIV infection or current TB infection.
•7\. Pregnant or breast\-feeding females.
•8\. Unwilling to use adequate contraception during the trial. Female participants of child\-bearing potential must be willing to use adequate contraception for the duration of the trial (24 months). Male participants with female partners of child\-bearing potential must be willing to use adequate contraception if they are randomised to the aHSCT arm until at least 6 months after discontinuation of cyclophosphamide.
•9\. Unable to comply with treatment protocol.
•10\. Contraindication to the use of cyclophosphamide, G\-CSF (filgrastim or lenograstim) or rabbit ATG.