EUCTR2014-004806-14-HU进行中（未招募）1 期
Single-Arm Study to Assess the Efficacy of UVADEX® (methoxsalen) Sterile Solution in Conjunction with the THERAKOS® CELLEX® Photopheresis System in Pediatric Patients with Steroid-Refractory Acute Graft Versus Host Disease (aGvHD)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
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
入选标准
- •Patients must meet all of the following criteria:
- •1.Male or female 1 to 21 years of age at the time of consent
- •2.Steroid-refractory grade B-C aGvHD
- •Steroid-refractory is defined as progressive aGvHD within 3 days of, or no response within 7 days of, starting systemic steroids at a dose of 2.0 mg/kg/day of methylprednisolone equivalents
- •3.A Karnofsky/Lansky Performance Status score = 30
- •4.Laboratory values are within the following limits, assessed within 3 days of the first study treatment:
- •Absolute neutrophil count > 0.5 × 109/L
- •Creatinine level < 2 times the upper limit of normal
- •5.For patients with isolated upper GI symptoms, pre-Screening biopsy results to confirm diagnosis of aGvHD
- •6.Female patients of childbearing potential and nonsterilized males who are sexually active with a female partner are committed to using effective methods of contraception, including abstinence, throughout their participation in the study and for 3 months following the last ECP treatment; females of childbearing potential are those who have reached the onset of menarche or 8 years of age, whichever comes first
- •7.Signed informed consent/assent is obtained before conducting any study procedures; the parent, legal guardian or legally authorized representative of a minor must also provide written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 48
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any of the following would exclude the patient from participation in the study:
- •1.Currently enrolled in another clinical trial for the treatment of acute GvHD
- •2.Use of any experimental regimens or medication(s) for acute GvHD treatment
- •3.Treatment with > 2.0 mg/kg/day of methylprednisolone equivalents for aGvHD within 30 days prior to the first study treatment
- •4.Development of aGvHD after donor lymphocyte infusion
- •5.Overt signs of relapse of the underlying condition
- •6.Uncontrolled viral, fungal, or bacterial infection
- •7.Platelet count < 20.0 × 109/L, despite platelet transfusion
- •8.Total bilirubin value = 15 mg/dL
- •9.Inability to tolerate the extracorporeal volume shifts associated with ECP treatment
- •10.Uncontrolled GI bleeding
- •11.Veno-occlusive liver disease
- •12.Life expectancy < 4 weeks
- •13.Patient requires invasive ventilation or vasopressor support
- •14.Known human immunodeficiency virus (HIV) or hepatitis B or C virus infection
- •15.Known hypersensitivity or allergy to methoxsalen
- •16.Known hypersensitivity or allergy to heparin or Anticoagulant Citrate Dextrose Formula-A (ACD-A)
- •17.Co-existing photosensitive disease (e.g., porphyria, systemic lupus erythematosus, albinism) or aphakia
- •18.Female patient is breastfeeding or pregnant
- •19.Any psychological, familial, sociological, and/or geographical condition that may potentially hamper compliance with the study protocol and the follow-up schedule
研究者
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