drugset / Trial / NCT05063513
Autologous Stem Cell Transplantation: International Lupus Trial
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate remission induction therapy for refractory Lupus Erythematosus with autologous hematopoietic stem cell transplantation (AHSCT) versus Rituximab (anti CD20) followed by maintenance therapy with mycophenolate mofetil (MMF).
Timeline
- Start
- 2009-07
- Primary completion
- 2013-07
- Completion
- 2017-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Bortezomib | Small molecule | 200 mg/kg | — |
| Background | Bortezomib | Small molecule | 4 g | — |
| Background | Mycophenolate Mofetil | Small molecule | 2 g | — |