RCT Comparing Autologous Hematopoietic Stem Cell Transplantation Versus Alemtuzumab in MS
Status:
Recruiting
Trial end date:
2024-03-21
Target enrollment:
Participant gender:
Summary
This study is a randomized multicentre, multinational, treatment interventional study of RRMS
patients with breakthrough inflammatory disease activity in spite of ongoing standard
immunomodulatory medication. The study has two treatment arms; arm A: HSCT (hematopoietic
stem cell transplantation) and arm B: alemtuzumab, a registered immunomodulatory treatment of
RRMS. A pre-planned 3-year follow-up extension period will be performed depending on future
funding.
The aim of the study is to assess the effectiveness and side effects of a new treatment
intervention in RRMS; HSCT, and, thereby, the value of HSCT in clinical practice. Data from
recently published patient series indicate that HSCT may have a significantly higher
treatment effect than currently registered RRMS immunomodulatory treatments. This study will
determine the relative role of HSCT versus alemtuzumab.