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Clinical Trial 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).

Clinical Trial Description

To compare the efficacy of Autologous Hematopoietic Stem Cell Transplantation (experimental arm) versus rituximab (control arm), followed by maintenance therapy with Mycophenolate Mofetil for patients with severe Systemic Lupus Erythematosus refractory to treatment with Cyclophosphamide and/or MMF alone plus steroids. Secondary Objectives - To evaluate the safety of AHSCT therapy versus rituximab (anti CD20) (control arm) with maintenance therapy by Mycophenolate Mofetil according to treatment related mortality and toxicity up to two years after randomization - To evaluate the long term efficacy in the study arms according to repeated measures of Disease Activity and Damage scores, Quality of Life, the presence of other co morbidities, the daily dose of steroids rated quarterly up to two years after randomization. - To evaluate in the study arms whether remission and disease activity correlates with immunological parameters, including immune reconstitution and auto antibodies Trial Design: Based on the existing European (28) and North American experience (29-31) of AHSCT in SLE, it is logical to suggest the following phase IIb trial designed in patients with severe refractory SLE after at least 6 months of best standard local therapy using either alone or successively according to current international clinical consensus as follows: - the short term Eurolupus protocol low dose CY regimen of 6 x 500 mg iv cyclophosphamide at 2 weeks interval or - the conventional treatment with 0.75 g/m2/month x 6 iv cyclophosphamide or - mycophenolate mofetil at 2 g/daily for 3 to 6 months plus oral steroids above 0.5 mg/kg/day and unable to decrease below 20 mg/day. All patients will be randomised at time of inclusion in one of two groups: - Group A (experimental arm) will undergo mobilisation with CY 4 g/m2 (in two divided doses), followed by Autologous Hematopoietic Stem Cell Transplantation using CY (200 mg/kg body weight given in 4 daily doses) plus ATG and unmanipulated autologous graft and maintenance by Mycophenolate Mofetil (2 g/day) starting 3 months after randomization. - Group B (control arm) will receive 4 successive weekly infusions of rituximab (antiCD20) 375 mg/m2 body surface area for four weeks and maintenance by Mycophenolate Mofetil (2 g/day) starting 3 months after randomization. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05063513
Study type Interventional
Source European Society for Blood and Marrow Transplantation
Status Withdrawn
Phase Phase 2/Phase 3
Start date July 2009
Completion date July 2017

See also
  Status Clinical Trial Phase
Recruiting NCT00698191 - Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE) Phase 1/Phase 2