NL-OMON52909招募中3 期
pfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized controlled trial - UPSIDE study
niversitair Medisch Centrum Utrecht0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Age between 18 and 65 years.
- •2. Fulfilling the 2013 ACR-EULAR classification criteria
- •3. Disease duration <= 2 years (from onset of first non-Raynaud*s symptoms) and
- •- mRSS >= 15 (diffuse skin pattern) and/or
- •- clinically significant organ involvement as defined by either:
- •a) respiratory involvement
- •b) renal involvement
- •c) cardiac involvement
排除标准
- •1. Pregnancy or unwillingness to use adequate contraception during study
- •2. Concomitant severe disease =
- •a) respiratory:
- •- pulmonary hypertension: a resting mean pulmonary artery pressure (mPAP) >
- •25 mmHg (by right heart catheterisation),
- •- DLCO < 40% predicted or
- •- respiratory failure as defined by the primary endpoint (see 7.1)
- •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 (10)
- •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, leading to exclusion of cyclo-
- •phosphamide, mycophenolate mofetil or autologous stem cell transplantation in
- •routine clinical practice.
- •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 (systolic blood pressure >150mmHg despite
- •medication)
- •Blood pressure needs to be controlled prior to inclusion
- •i) uncontrolled acute or chronic infection, including HIV, HTLV-1,2 positivity,
- •leading to exclusion of cyclo-
- •phosphamide, mycophenolate mofetil or autologous stem cell transplantation in
- •routine clinical practice.
- •Infection needs to be treated/controlled prior to inclusion.
- •j) ZUBROD-ECOG-WHO Performance Status Scale > 2
- •k) Known hypersensitivity to any of the study drug constituents
- •3. Previous treatments with immunosuppressants > 6 months including MMF,
- •methotrexate, azathioprine, rituxi-mab, tocilizumab, glucocorticosteroids.
- •4. Previous treatments with TLI, TBI or alkylating agents including
- •cyclophosphamide.
- •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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