EUCTR2010-022780-35-ES进行中（未招募）1 期
A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy with UVADEX TM for the Treatment of Patients with Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD).
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
- 60
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. Are able to provide written informed consent.
- •2. Meet NIH diagnostic criteria for initial onset of moderate to severe cGvHD with onset within 2 years of transplantation. Patients with prior acute cGvHD symptoms should be on a stable dose of <0.5 mg prednisone equivalent for at least 2 weeks prior to study entry.
- •3. Age ? 18 years.
- •4. Weight > 40 kg.
- •5. Platelet count > 25,000/?L.
- •6. Eastern Cooperative Oncology Group (ECOG) score of 0-2.
- •7. Life expectancy of at least 3 months with no imminent relapse expected.
- •8. Women of childbearing potential and all men must be using adequate birth control measures (e.g., abstinence,oral contraceptive, intrauterine device, barrier method with spermicide, or surgical sterilization) throughout the study.
- •9. Women with childbearing potential must provide a negative pregnancy test within 10 days before study start.
- •10. Patients must be able and willing to comply with all study procedures.
- •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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Corticosteroid intolerance, based on previous clinical experience.2. Previous treatment with > 0.5 mg/kg daily prednisone, or equivalent, for cGvHD for more than 72 hours prior
- •to randomization.
- •3. Evidence of known infection with human immunodeficiency virus (HIV) or active Hepatitis B.
- •4. Requires treatment with budesonide.
- •5. Expected to receive donor lymphocyte infusion (DLI).
- •6. Uncontrolled infection requiring treatment at study entry.
- •7. Known definite bronchiolitis obliterans (biopsy proven).
- •8. Patients who have received biologic therapy as part of treatment for acute cGvHD or conditioning regimen
- •which is expected to have a prolonged effect (e.g., alemtuzumab).
- •9. Hypersensitivity or allergy to psoralen (methoxsalen).
- •10. Hypersensitivity or allergy to both heparin and citrate products. (If hypersensitive or allergic to only one of
- •these two products, exclusion does not apply).
- •11. Inability to tolerate fluid changes associated with ECP (e.g., adequate renal, hepatic, pulmonary and cardiac
- •function leading to enable patient to tolerate extracorporeal volume shifts associated with ECP).
- •12. Presense of aphakia or photosensitive disease (systemic lupus erythromatosus, porphyrias, albinism, etc.).
- •13. Women who are pregnant and/or lactating.
- •14. Participation in another clinical trial for treatment of cGvHD within 28 days prior to randomization.
研究者
相似试验
进行中（未招募）
1 期
A clinical study in patients with moderate to severe graft-versus-host disease, patients randomly assigned to standard of care or to standard of care plus Extracorporeal (ECP) Therapy with UVADEX™EUCTR2010-022780-35-HUTHERAKOS, Inc.60
进行中（未招募）
不适用
A clinical study in patients with moderate to severe graft-versus-host disease, patients randomly assigned to standard of care or to standard of care plus Extracorporeal (ECP) Therapy with UVADEX™Chronic graft-versus-host disease (cGvHD)MedDRA version: 14.1Level: PTClassification code 10018651Term: Graft versus host diseaseSystem Organ Class: 10021428 - Immune system disordersEUCTR2010-022780-35-ITTHERAKOS60
进行中（未招募）
1 期
A clinical study in patients with moderate to severe graft-versus-host disease, patients randomly assigned to standard of care or to standard of care plus Extracorporeal (ECP) Therapy with UVADEX™Chronic graft-versus-host disease (cGvHD)MedDRA version: 14.1 Level: PT Classification code 10018651 Term: Graft versus host disease System Organ Class: 10021428 - Immune system disordersEUCTR2010-022780-35-GBTHERAKOS, Inc.60
进行中（未招募）
1 期
A clinical study in patients with moderate to severe graft-versus-host disease, patinets randomly assigned to standard of care or to standard of care plus Extracorporeal (ECP) Therapy with UVADEX™EUCTR2010-022780-35-ATTHERAKOS, Inc.60
进行中（未招募）
1 期
A clinical study in patients with moderate to severe graft-versus-host disease, patinets randomly assigned to standard of care or to standard of care plus Extracorporeal (ECP) Therapy with UVADEX™EUCTR2010-022780-35-DETHERAKOS, Inc.60