EUCTR2006-004598-83-GB进行中（未招募）不适用
High dose immunoablation and autologous hematopoietic stem cell transplantation versus monthly intravenous pulse therapy cyclophosphamide in severe systemic sclerosis ( ‘ASTIS’-TRIAL: Autologous Stem Cell Transplantation International Scleroderma Trial) - ASTIS
EBMT (European group for Blood and Marrow Transplantation)0 个研究点目标入组 150 人开始时间: 2008年10月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age between 18 and 65 years.
- •2. Established diagnosis of systemic sclerosis according to ARA-criteria.
- •3. Diffuse scleroderma with disease duration either: a. less than or equal 2 years since development of first sign of skin thickening, plus modified Rodnan skin score greater than or equal 20, plus involvement of trunk plus ESR > 25 mm/1st hour and/or Hb < 11 g/dL, not explained by other causes than active scleroderma,
- •less than or equal 4 years since development of first sign of skin thickening, plus modified Rodnan skin score greater than or equal 15, plus major organ involvement (with documented evidence of onset or clinically significant worsening in the previous 6 months) as defined by either:
- •a) Respiratory involvement = DLCO and/or (F)VC less than or equal 80% (of predicted) and evidence of interstitial lung disease (chest X-ray and/or HR-CT scan and/or bronchoalveolar lavage and/or biopsy of the lungs) with clinically relevant obstructive disease and emphysema excluded.
- •b) Renal involvement = any of the following criteria: hypertension (two successive BP readings of either systolic greater than or equal 160 mm Hg or diastolic > 110 mm Hg, at least 12 hours apart), persistent urinalysis abnormalities (proteinuria, hematuria, casts), microangiopathic hemolytic anemia, new renal insufficiency (serum creatinine > upper limit of normal); non-scleroderma related causes (e.g. medication, infection etc.) must be reasonably excluded.
- •c) Cardiac involvement = any of the following criteria: reversible congestive heart failure, atrial or ventricular rhythm disturbances such as recurrent episodes of atrial fibrillation or flutter, recurrent atrial paroxysmal tachycardia or ventricular tachycardia, 2nd or 3rd degree AV-block, pericardial effusion; non-scleroderma related causes must have been reasonably excluded by an experienced cardiologist.
- •4. Written informed consent
- •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
排除标准
- •1. Pregnancy or unwillingness to use adequate contraception during study
- •2. Concomitant severe disease =
- •2.1 respiratory: mean PAP > 50 mmHg (by cardiac echo or right heart catheterization), DLCO < 40% predicted, respiratory failure as defined by the primary endpoint
- •2.2 renal: creatinine clearance < 40 ml/min (measured or estimated)
- •2.3 cardiac: clinical evidence of refractory congestive heart failure; LVEF < 45% by multigated radionuclide angiography (MUGA) or cardiac echo; chronic atrial fibrillation necessitating oral anticoagulation; uncontrolled ventricular arrhythmia; pericardial effusion with hemodynamic consequences as evaluated by an experienced echocardiographist
- •2.4 liver failure as defined by a sustained 3-fold increase in serum transaminase or bilirubin
- •2.5 psychiatric disorders including active drug or alcohol abuse
- •2.6 concurrent neoplasms or myelodysplasia
- •2.7 bone marrow insufficiency defined as leucocytopenia < 4.0 x 109/L, thrombocytopenia < 50 x 109/L, anemia < 8 gr/dL, CD4+ T lymphopenia < 200 x 106/L
- •2.8 uncontrolled hypertension
- •2.9 uncontrolled acute or chronic infection, including HIV, HTLV-1,2 positivity
- •3. Previous treatments with TLI, TBI or alkylating agents including cyclophosphamide
- •(> 5 g i.v. cumulative, or > 3 months oral up to 2 mg/kg b.wt).
- •4. Significant exposure to bleomycin, tainted rapeseed oil, vinyl chloride, trichlorethylene or silica; eosinophilic myalgia syndrome; eosinophilic fasciitis.
- •5. Poor compliance of the patient as assessed by the referring physicians.
研究者
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