Clinical Trial Results:
Induction of Tolerance with Immunoablation and
Autologous Hematopoietic Stem Cell Transplantation (ASCT) for
Severe Systemic Lupus Erythematosus (SLE) Refractory to
Standard Immunosuppressive Therapy
AN OPEN-LABEL, CONTROLLED, PHASE II MULTICENTER TRIAL OF IMMUNOABLATIVE CHEMOTHERAPY WITH CYCLOPHOSPHAMIDE AND ANTI-THYMOCYTE GLOBULIN AND TRANSPLANTATION OF PURIFIED CD34+ AUTOLOGOUS HEMAPOIETIC STEM CELLS VERSUS CURRENTLY AVAILABLE IMMUNOSUPPRESSIVE THERAPY FOR THE TREATMENT OF REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS.
|
Summary
|
|
EudraCT number |
2006-001269-40 |
Trial protocol |
DE |
Global completion date |
|
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
30 Oct 2025
|
First version publication date |
30 Oct 2025
|
Other versions |
|
Summary report(s) |
p.e..statement |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.