T86.02
Conditions
Interventions
Group 1: Patients with newly diagnosed acute GvHD will be treated with ssECP as first line treatment. ssECP is a down scale version of ECP which is currently used as second line treatment for patients
Sponsors
Universitätsklinikum Freiburg (vertreten durch den ärztlichen Direktor)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: Hypersensitivity or allergy to psoralen (methoxypsoralen, methoxsalen) or auxiliary supplies. Earlier splenectomy. Leukocytosis of >25 000/µl. Previous acute GvHD treatment. White blood count 700 mg/dl) Patients who are not able to tolerate daily withdrawal of 50 or 100 ml blood for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Number of patients who respond to ssECP for the treatment of acute GvHD on day 7 -Number of patients who discontinue treatment due to toxicities or failure to respond to the ssECP procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with relapses of after ssECP Number of patients with late response (later than d7 after initiation of ssECP) Induction of apoptosis in the ECP product. Immunological Characterization of pro-and anti-inflammatory cytokines before, during and after ssECP treatment, number of regulatory T cells in patients´ blood samples. | — |
Countries
Germany
Contacts
Public ContactAnke Peters
ZKJ
Outcome results
None listed