Small-scale Extracorporeal Photopheresis for the Treatment of Acute Graft-versus-Host Disease - ssECP bei akuter GvHD

niversitätsklinikum Freiburg (vertreten durch den ärztlichen Direktor)0 个研究点目标入组 41 人开始时间: 2010年1月27日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Signed written informed consent from the patient or patient?s legal guardian in case of minors and assent of minor.
•Newly diagnosed grad II to III acute GvHD following allogeneic HSCT for malignant disorders (e.g. acute leukaemia, chronic leukaemia, advanced MDS) until d +100 after HSCT (for details of GvHD diagnosis see Sec. 8.3.1.3).
•Body weight of at least 10 kg.

•Hypersensitivity or allergy to psoralen (methoxypsoralen, methoxsalen) or auxiliary supplies.
•Earlier splenectomy.
•Leukocytosis of >25 000/µl.
•Previous acute GvHD treatment.
•White blood count < 500/µl.
•Critically ill patients (e.g. mechanical ventilator support, ionotropic infusions).
•Evidence of organ failure (renal, liver, lung, cardiac, etc.).
•Patients who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the study.
•Patients unwilling or unable to give written informed consent.
•Pregnancy and nursing.
•Women of childbearing age without safe method of contraception.
•Participation in a clinical trial within the last 30 days before the start of the study, or simultaneous participation in another clinical trial.
•Known drug/alcohol abuse.
•Patients with diseases associated with photosensitivity (e.g. lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum or albinism).
•Patients with aphakia.
•Patients with a history of melanoma, basal cell carcinoma or squamous cell carcinoma of the skin.
•Patients with excessive hypertriglyceridemia ( > 700 mg/dl)
•Patients who are not able to tolerate daily withdrawal of 50 or 100 ml blood for any other reason.

发起方

niversitätsklinikum Freiburg (vertreten durch den ärztlichen Direktor)