NCT03124056已完成不适用
Clinical and Biological Study of the Efficacy of the Use of Closed Extracorporeal Photopheresis in Acute or Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Transplantation
Fundación para la Investigación del Hospital Clínico de Valencia0 个研究点目标入组 62 人开始时间: 2013年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- Graft versus host disease Response
研究概览
简要总结
The aims of the study:
- To evaluate the clinical efficacy of the use of extracorporeal photopheresis in the treatment of Graft-versus-host disease under standard clinical indications as pre-defined by the participants Centers (members of the Spanish Group for Hematopoietic Transplantation).
- To explore and identify biomarkers of clinical response to extracorporeal photopheresis treatment of acute or chronic Graft-versus-host disease after Allogeneic hematopoietic stem cell transplantation
详细描述
Title: Exploratory study of biomarkers associated with clinical response to extracorporeal photopheresis in the treatment of acute and chronic graft-versus-host disease post allogeneic hematopoietic stem cell transplantation
Objectives:
- To evaluate the clinical efficacy of the use of extracorporeal photopheresis in the treatment of acute or chronic Graft-versus-host disease under standard clinical indications as pre-defined by the participants Centers (Spanish Group for Hematopoietic Transplantation).
- To explore and identify biomarkers of clinical response to extracorporeal photopheresis by means of a comprehensive analysis of different immune populations including T, B and Natural Killer cells, prior to and within the episodes of clinical graft-versus-host disease and the kinetic profile of plasma cytokines (Interferon-gamma, B cell activating factor, Tumor Necrosis Factor-alfa and Interleukin-6) in relation with Graft-versus-host disease .
Methods:
50 patients with acute or chronic graft-versus-host disease after Allogeneic hematopoietic stem cell transplantation whatever be the cell source (blood, bone marrow or cord blood), diagnosed and treated in one of the participant centers with closed extracorporeal photopheresis in the indications detailed bellow, will be analyzed in order to identify potential biomarkers of Graft versus host disease-response. Analyses of T, B and Natural Killer populations will be performed by Intracellular Cytokine Staining and Flow Cytometry. Cytokine measurement in plasma will be performed by Enzyme-Linked ImmunoSorbent Assay. Participants Centers:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute or chronic graft-versus-host disease resistant or dependent to corticosteroids after Allogeneic Hematopoietic transplantation whatever be the cell source (blood, bone marrow or cord blood), diagnosed and treated in one of the participant centers
- •Definitions:
- •Acute Graft versus host disease:
- •Refractory to corticosteroids: progression after 3-4 days of standard first line treatment with calcineurin inhibitor and glucocorticoids or no response after 7 days.
- •Corticosteroids dependent: flare o evidence of progression of Graft versus host disease in the same or new affected organ after reduction of full dose (2 mg/Kg/día), that has been maintained for at least 2 weeks.
- •Acute Graft versus host disease grade ≥ II, with response to 1st line treatment with cyclosporine A and prednisone in patients who present intolerable adverse effects that preclude to maintain this treatment as evaluated by the responsable physician.
- •Patient with viral reactivation during acute Graft versus host disease that need reduction of immunosuppression as evaluated by the responsable physician.
- •Chronic Graft versus host disease: Muco-cutaneous or hepatic moderate or severe chronic Graft versus host disease (as defined by NIH Consensus Group criteria (Biol Blood Marrow Transplantation 2005;11:945), refractory to steroids (1 mg/Kg/day of methylprednisolone during 15-30 days) or steroid-dependent (requiring more than 10 mg/day of methylprednisolone to control manifestations).
- •Associated to corticosteroids if exists contraindication for calcineurin inhibitors.
- •Associated to calcineurin inhibitors and corticosteroids in case of pulmonary chronic Graft versus host disease diagnosis (optional) Second line
- •Progressive cutaneous moderate or severe chronic Graft versus host disease after acute Graft versus host disease that is being treated with calcineurin inhibitors and corticosteroids.
- •Moderate or severe cutaneous (both lichenoid or sclerodermiform) o mucosal chronic Graft versus host disease refractory to corticosteroids:
- •No Partial remission after 1 month of treatment
- •No Complete remission after 3 months of treatment
- •Disease progression after 2-3 weeks of treatment
排除标准
- •uncontrolled Infections
- •Performance score <3
- •Lack of adequate vascular access
结局指标
主要结局
Graft versus host disease Response
时间窗: 2 years
Rate of clinical partial and complete response of acute and chronic Graft versus host disease to the intervention
次要结局
- To determine rate of moderate and severe toxicity associated to extracorporeal photopheresis(2 years)
- To identify biomarkers associated with clinical response to extracorporeal photopheresis(2 years)
研究者
相似试验
进行中（未招募）
3 期
Extracorporeal Photopheresis for Medicare Recipients of Lung AllograftsBronchiolitis Obliterans Syndrome (BOS)NCT02181257Washington University School of Medicine280
招募中
不适用
A Prospective Randomized Trial of ECP in Subclinical AMRAntibody-mediated RejectionLung Transplant RejectionNCT06112951Medical University of Vienna80
撤回
1 期
RHIV A Pilot Study Refractory or Intolerant to Highly Active Antiretroviral Therapy (HAART)HIV InfectionsNCT00157027Atlantic Health System
已完成
2 期
Photopheresis for the Treatment of Acute Graft Versus Host DiseaseGraft Versus Host DiseaseNCT00609609M.D. Anderson Cancer Center81
尚未招募
不适用
Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For Actinic KeratosesActinic KeratosesNCT06545396Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal20