NL-OMON26075尚未招募不适用
pfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized con-trolled trial
niversity Medical Centre Utrecht0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age between 18 and 65 years.
- •2. Fulfilling the 2013 ACR-EULAR classification criteria for SSc (appendix B).
- •3. Disease duration = 2 years (from onset of first non-Raynaud’s symptoms) and diffuse cutaneous disease with
- •- mRSS = 15 and/or
- •- clinically significant organ involvement as defined by either:
- •a)respiratory involvement =
- •i. DLCO and/or (F)VC = 85% (of predicted) and evidence of interstitial lung disease on HR-CT scan with clinically relevant obstructive disease and emphysema excluded.
- •ii. Patients with a DCLO and/or FVC > 85%, but with a progressive course of lung disease: defined as relative decline of >10% in FVC predicted and/or TLC predicted, or >15% in DLCO predicted and evidence of interstitial lung disease on HR-CT scan with clinically relevant obstructive disease and emphysema excluded, within 12 months. Intercurrent infections excluded.
- •b)renal involvement = any of the following criteria: hypertension (two successive BP readings
- •of either systolic = 160 mm Hg or diastolic > 110 mm Hg, at least 12 hours apart), persistent
- •urinalysis abnormalities (proteinuria, haematuria, casts), microangiopathic haemolytic anaemia,
- •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 atrial fibrillation or flutter, atrial paroxysmal tachycardia or ventricular tachycardia, 2nd or 3rd degree AV block, pericardial effusion (not leading to hemodynamic problems), myocardi-tis; non-scleroderma related causes must have been reasonably excluded.
- •4. Written Informed consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •1. Pregnancy or unwillingness to use adequate contraception during study
- •2. Concomitant severe disease =
- •a)respiratory: resting mean pulmonary artery pressure (mPAP) > 20 mmHg (by right heart catheterisa
- •tion), DLCO < 40% predicted, respiratory failure as defined by the primary endpoint
- •b)renal: creatinine clearance < 40 ml/min (measured or estimated)
- •c)cardiac: clinical evidence of refractory congestive heart failure; LVEF < 45% by cardiac echo or cardiac
- •MR; chronic atrial fibrillation necessitating oral anticoagulation; uncontrolled ventricular
- •arrhythmia; pericardial effusion with hemodynamic consequences
- •d)liver failure as defined by a sustained 3-fold increase in serum transaminase or bilirubin, or a Child-
- •Pugh score C
- •e)psychiatric disorders including active drug or alcohol abuse
- •f)concurrent neoplasms or myelodysplasia
- •g)bone marrow insufficiency defined as leukocytopenia < 4.0 x 109/L, thrombocytopenia < 50
- •x 109/L, anaemia < 8 gr/dL, CD4+ T lymphopenia < 200 x 106/L
- •h)uncontrolled hypertension
- •i)uncontrolled acute or chronic infection, including HIV, HTLV-1,2 positivity
- •j)ZUBROD-ECOG-WHO Performance Status Scale > 2
- •3. Previous treatments with immunosuppressants > 6 months including MMF, methotrexate, azathioprine, rituximab, tocilizumab, glucocorticosteroids.
- •4. Previous treatments with TLI, TBI or alkylating agents including CYC.
- •5. Significant exposure to bleomycin, tainted rapeseed oil, vinyl chloride, trichlorethylene or silica;
- •6. eosinophilic myalgia syndrome; eosinophilic fasciitis.
- •7. Poor compliance of the patient as assessed by the referring physicians.
研究者
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