Status:
UNKNOWN
Autologous Stem Cell Transplantation for Refractory Systemic Lupus Erythematosus (ASSIST)
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
While glucocorticoids and immunosuppressants ameliorate manifestations of SLE in many patients, current therapies are insufficient to control the disease in a subset of patients, and their clinical pr...
Eligibility Criteria
Inclusion
- Diagnosis of SLE according to American College of Rheumatology (ACR) classification criteria
- Age between 18 and 60 years, inclusive
- Provision of informed consent
- Active disease, refractory to standard immunosuppressive therapy defined as:
- BILAG level A and a SLEDAI-score of at least 10, despite treatment with high-dose corticosteroids and pulse intravenous CYC at doses of 500-1000mg/m2 for at least 6 months or mycophenolate mofetil (MMF) at doses of at least 2g -
- Lupus nephritis with renal biopsy performed within one year prior to screening showing glomerulonephritis WHO class III or IV
- Parenchymal disease of heart or lung
- Neuropsychiatric lupus
- Autoimmune cytopenia OR
- recurrence of disease activity (defined as BILAG level A and a SLEDAI of at least 10) within one year after successful induction therapy with cyclophosphamide or MMF in the presence of an adequate maintenance therapy with either cyclophosphamide (at least 500mg/m2 monthly), mycophenolate mofetil (at least 2g daily), azathioprine (at least 1.5mg/kg/d), methotrexate (at least 15mg weekly), cyclosporine (at least 3mg/kg/d) in patients with persistent anti-dsDNA antibodies
Exclusion
- Severe concomitant disease or organ damage
- renal: renal insufficiency with glomerular filtration rate below 40ml/min
- cardiac: congestive heart failure, LVEF \< 40% determined by echocardiogram, uncontrolled arrhythmia
- pulmonary: mean pulmonary arterial pressure \>50mmHg, DLCO \< 40 % predicted
- gastrointestinal: liver cirrhosis; SGOT, SGPT greater than 2 x the upper limit of normal, unless due to active lupus
- Ongoing cancer or history of malignancy within 5 years of screening
- Women who are pregnant or breastfeeding or use non-reliable methods of contraception
- Subjects with active systemic infection
- Subjects with history of active viral infection within 6 months prior to screening, known HIV-infection or chronic Hepatitis B or Hepatitis C
- History of allergic reaction to cyclophosphamide, G-CSF or ATG
- Use of immunosuppressive agents for indications other than SLE
- Any comorbidity that in the opinion of the investigator would jeopardize the ability of the subject to tolerate therapy
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00750971
Start Date
August 1 2008
End Date
August 1 2020
Last Update
March 20 2017
Active Locations (8)
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1
Universitätsmedizin Charité
Berlin, Germany, 10117
2
Universitätsklinik Köln
Cologne, Germany, 50937
3
Universitätsklinik Düsseldorf
Düsseldorf, Germany, 40225
4
Universitätsklinikum Essen
Essen, Germany, 45239 Essen