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2019年10月2日
适应症ew onset high risk acute GvHD following allogeneic SCTMedDRA version: 20.0Level: LLTClassification code 10018653Term: Graft-versus-host disease <GVHD>System Organ Class: 100000004870Therapeutic area: Diseases [C] - Immune System Diseases [C20]
相关药物UVADEX
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- ew onset high risk acute GvHD following allogeneic SCT
- 发起方
- Department of Stem Cell Transplantation - University Medical Center Hamburg-Eppendorf
- 入组人数
- 72
- 状态
- 进行中（未招募）
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
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\).
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)
结局指标
主要结局
未指定
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