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. - ASSIST

Charité University Medicine0 个研究点目标入组 30 人开始时间: 2008年3月11日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Diagnosis of SLE according to American College of Rheumatology (ACR)
•classification criteria for SLE
•2. Age between 18 and 60 years, inclusive
•3. Provision of informed consent by subject or legally acceptable
•representative
•4. Severe disease, refractory to standard immunosuppressive therapy
•defined as:
•- failure of remission after treatment with high-dose corticosteroids and pulse intravenous CYC at doses of 500-1000mg/m2 for at least 6 months (defined as BILAG level A) for one of the following:
•?Biopsy proven glomerulonephritis WHO class III or class IV
•?Parenchymal disease of heart or lung
•?Neuropsychiatric lupus
•?Autoimmune cytopenia
•- recurrence of disease activity (defined as new BILAG level A) within one year of clinical remission in the presence of an adequate maintenance therapy (intravenous Cyclophosphamide, Mycophenolate Mofetil, Azathioprine, Methotrexate, IVIG, Cyclosporine, Rituximab)
•in patients with persistent anti-dsDNA antibodies
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Severe concomitant disease or organ damage
•a) Renal: chronic renal insufficiency with creatinine-clearance <40ml/min or serum
•creatinine concentration >3mg/dl
•b) Cardiac: congestive heart failure, LVEF < 40% determined by echocardiogram
•uncontrolled arrhythmia
•c) Pulmonary: mean PAP >50mmHg, TLCO/VA <40 % predicted
•d) Gastrointestinal: liver cirrhosis (Child Pugh classification B or C)
•2. Concurrent malignancy or history of malignancy within 5 years of
•3. Women who are pregnant or breastfeeding or use non-reliable
•methods of contraception
•4. Subjects with a history of viral infection (CMV, EBV, HCV) within 6
•prior to screening, or known HIV-infection
•5. History of allergy to cyclophosphamide or anti-thymocyte globulin

发起方

Charité University Medicine