Small-scale Extracorporeal Photopheresis for the Treatment of Acute Graft-versus-Host Disease
- Conditions
- T86.02
- Registration Number
- DRKS00000299
- Lead Sponsor
- niversitätsklinikum Freiburg (vertreten durch den ärztlichen Direktor)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting withdrawn before recruiting started
- Sex
- All
- Target Recruitment
- 41
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Number of patients who respond to ssECP for the treatment of acute GvHD on day 7 <br>-Number of patients who discontinue treatment due to toxicities or failure to respond to the ssECP procedure
- Secondary Outcome Measures
Name Time Method umber of patients with relapses of after ssECP<br>Number of patients with late response (later than d7 after initiation of ssECP)<br>Induction of apoptosis in the ECP product.<br>Immunological Characterization of pro-and anti-inflammatory cytokines before, during and after ssECP treatment, number of regulatory T cells in patients´ blood samples.