EUCTR2014-004806-14-GB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 vs 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
- 性别
- All
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-D aGvHD
- •* Steroid-refractory is defined as a failure to respond to steroid treatment, with failure to respond defined as any grade B-D (IBMTR
- •grading) aGvHD that shows progression = 3 days, or no improvement by 5 days of treatment with 2 mg/kg/day of methylprednisolone or equivalent in patients with lower GI or liver disease, or skin disease associated with bullae. Grade D organ involvement will be limited to skin and liver.
- •* Steroid refractory may also be defined as a failure to respond to 1 mg/kg/day of methylprednisolone or equivalent in patients with disease confined to upper GI disease or lesser degrees of skin GvHD.
- •* Patients with lack of complete response after 2 weeks of steroid treatment.
- •3. A Lansky Scale 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 gastrointestinal (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 must be practicing highly
- •effective, reliable, and medically approved contraceptive regimen throughout their participation in the study and for 3 months following
- •the last ECP treatment. Or, for the US only, abstinence may be used in place of an approved contraceptive regimen. Females of childbearing
- •potential are those who have reached the onset of menarche, or 8 years of age, whichever comes first. Approved contraceptive methods for
- •female patients of childbearing potential or nonsterilized males who are sexually active with a female partner are as follows:
- •* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- •* Established use of oral, injectable, or implanted hormonal methods of contraception.
- •* Placement of an intrauterine device or intrauterine system.
- •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 aGvHD.
- •2. Use of any experimental regimens or medication(s) for aGvHD treatment.
- •3. Treatment with > 2.0 mg/kg/day of methylprednisolone equivalents for aGvHD within 30 days prior to the first study treatment.
- •4. Overt signs of relapse of the underlying condition.
- •5. Uncontrolled viral, fungal, or bacterial infection.
- •6. Platelet count < 20.0 × 109/L, despite platelet transfusion.
- •7. Total bilirubin value = 15 mg/dL.
- •8. Inability to tolerate the extracorporeal volume shifts associated with ECP treatment.
- •9. Uncontrolled GI bleeding.
- •10. Veno-occlusive liver disease.
- •11. Life expectancy < 4 weeks.
- •12. Patient requires invasive ventilation or vasopressor support.
- •13. Known human immunodeficiency virus (HIV) or hepatitis B or C virus infection (proof of seronegativity within 6 months of screening is required).
- •14. Known allergy or hypersensitivity to methoxsalen, Uvadex, or its excipients.
- •15. Known hypersensitivity or allergy to heparin and Anticoagulant Citrate Dextrose Formula-A (ACD-A).
- •16. Co-existing photosensitive disease (e.g., porphyria, systemic lupus erythematosus, albinism) or aphakia.
- •17. Coagulation disorders that cannot be corrected with simple transfusion.
- •18. Co-existing melanoma, basal cell, or squamous cell skin carcinoma.
- •19. Previous splenectomy.
- •20. White blood cell count greater than 25,000 mm3.
- •21. Currently being treated with any systemic immunosuppressive or biologic therapy for the treatment of a medical condition other than aGvHD.
- •22. Female patient is breastfeeding or pregnant.
- •23. Any medical concerns that may pose risk to the patient.
- •24. 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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