Autoimmune Diseases Clinical Trial
Official title:
Post-AHSCT (Autologous Hematopoietic Stem Cell Transplantation) Management for Patients With Systemic Sclerosis: a Prospective, Non-interventional Approach Across Europe (NISSC-2) for the Autoimmune Diseases Working Party of the European Group for Blood and Marrow Transplantation (EBMT)
The aim of the study is to assess the effectiveness of various post-transplant treatment management approaches on clinical and immune biological responses after Autologous Hematopoietic Stem Cell transplantation (AHSCT) for Systemic Sclerosis (SSc) as currently performed by the different treatment protocols used in routine clinical practice across Europe in various EBMT centres
NISSc-2 is a prospective observational study specifically designed to assess the
effectiveness of various post-transplant treatment management approaches on clinical and
immune biological responses after Autologous Hematopoietic Stem Cell transplantation (AHSCT)
for Systemic Sclerosis (SSc) as currently performed by the different treatment protocols used
in routine clinical practice across Europe in various EBMT centres through the careful
recording and analysis of routinely collected clinical and immune biological data, and
specific data regarding post-transplant use of SSc active treatments, including:
- Steroids,
- SSc active treatments after AHSCT such as mycophenolate mofetil (MMF), azathioprine,
cyclophosphamide (oral or IV), methotrexate, polyclonal antibodies (such as ATG) or
monoclonal antibodies (rituximab, belimumab or any others) as well as their respective
dosage and duration of each treatment. These post-transplant treatments can be
administered for various reasons, which can be specified by local investigators, such as
per local protocol decision for maintenance therapy, or for disease progression with or
without prior clinical response, during routine clinical follow-up. Patients who do not
receive any post-transplant therapy will also be observed.
Different protocols are used in the different centres, but it is not yet clear, which
approach will be the most efficient and the safest. The role of stem cell purification with
CD34-selection also needs to be determined prospectively.
In addition, the EBMT Autoimmune Diseases and Immunobiology Working Parties developed and
implemented guidelines for 'good laboratory practice' in relation to procurement, processing,
storage and analysis of biological specimens for immune reconstitution studies in AD patients
before, during and after AHSCT [16]. To follow post-transplant immune reconstitution
according to ADWP GCP, results of routine analyses performed by centres under standardized
conditions on available biological samples will be investigated in correlation to clinical
outcome parameters. Every centre will follow its own local protocol for AHSCT, which usually
refers to the recent update of the EBMT guidelines for AHSCT in autoimmune disease.
We therefore specifically designed NISCC-II to prospectively capture various post-ASHCT
management protocols and their effect on the observed clinical response after AHSCT.
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