EUCTR2019-000894-22-DE进行中（未招募）1 期
Phase II multicenter study of extracorporeal photopheresis with UvadexTM plus standard steroid treatment for high risk acute Graft-versus-Host Disease
Department of Stem Cell Transplantation - University Medical Center Hamburg-Eppendorf0 个研究点目标入组 72 人开始时间: 2019年10月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
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. New onset high risk acute GvHD (Ann Arbor score 2/3 as defined in Appendix A) following allogeneic SCT. Any clinical severity (Glucksberg grade I-IV) is eligible.
- •2. Any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood). Recipients of non-myeloablative and myeloablative transplants are eligible.
- •3. No prior systemic treatment for acute GvHD except for a maximum of 7 days of methylprednisolone =2 mg/kg/day (or IV Methyprednisolone equivalent) during the period from the initiation of systemic steroid treatment for acute GvHD until study therapy begins. Topical skin steroid treatment and non-absorbable oral steroid treatment for GI GvHD are permissible.
- •4. Age 18 years or older.
- •5. Platelet count > 25.000 (including platelet support)
- •6. Eastern Coorperative Oncology Group (ECOG) score of 0=2 unless due to aGvHD
- •7. Negative pregnancy test within 10 days before start of study if the patient is a woman of child-bearing age
- •8. Direct bilirubin must be <2 mg/dL unless the elevation is known to be due to Gilbert syndrome or aGvHD within 3 days before screening.
- •9. ALT/SGPT and AST/SGOT must be <5 x the upper limit of the normal range within 3 days before screening.
- •10. Females/Males who agree to comply with the applicable contraceptive requirements of the protocol (see section 11).
- •11. Written informed consent from patient.
- •12. Biopsy of acute GvHD target organ is strongly recommended but not required. Enrollment should not be delayed for biopsy or pathology results. Patients who do not start ECP within 5 working days of initiation of systemic steroid treatment for acute GvHD are not permitted to par-ticipate.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •1. Progressive or relapsed malignancy
- •2. Uncontrolled active infection
- •3. Patients with chronic GvHD
- •4. History of or current diagnosis of progressive multifocal leu-koencephalopathy (PML)
- •5. Pregnant or nursing (lactating) women
- •6. Use of other drugs for the treatment of acute GvHD apart from on-going GvHD prophylaxis and corticosteroids
- •7. Patients on dialysis
- •8. Patients requiring ventilator support
- •9. Evidence of known infection with human immunodeficiency virus (HIV) or active hepatitis B
- •10. Investigational agent within 30 days of enrollment without approval from the Sponsor-Investigator (PI). (Off-label use of medication is not considered investigational unless in context of a formal study)
- •11. History of allergic reaction to 8-MOP
- •12. Concomitant diagnosis of malignant melanoma or basal cell carci-noma
- •13. Hypersensitivity or allergy to both heparin and citrate products (if hypersensitive or allergic only to one, exclusion does not apply)
- •14. Inability to tolerate extracorporeal volume shifts associated with ECP
- •15. Presence of aphakia
- •16. History of splenectomy
- •17. Leucocyte count > 25.000/ul
- •18.Coagulopathy
- •19. Known photosensitive disease like systemic lupus erythematosus, porphyrias or albinism
研究者
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