Status:
UNKNOWN
Cryopreservation of White Blood Cells Before Their UVA Irradiation for Graft Versus Host Disease Treatment
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Extracorporeal photopheresis (ECP) is a worldwide recognized treatment of acute and chronic mild to moderate graft versus host disease (GVHD), in second or further line of treatment. Contrary to immun...
Detailed Description
The main objective of this prospective interventional pilot study is to demonstrate the ability of this technique to follow high intensity regimen recommendations, as mentioned above: * 3 ECP session...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Adult or child who received an allogeneic hematopoietic stem cell transplantation, with a medical follow-up at the University Hospital of Nancy, or at the other University Hospitals in the great East region (Dijon, Reims, Besançon) in which ECP is not accessible.
- Eligible for ECP for the treatment of acute or chronic steroid refractory GVHD, after pluridisciplinary concertations
- Patients (or parents) who received full information on the research and who signed a consent for this research
- Non inclusion Criteria:
- Children under 10 kg of weight
- Patients or parents who did not sign a consent
- Patients who present an absolute contra-indication for apheresis: recent pulmonary embolism, deep vein thrombosis, myocardial infarction, active and evolutive bacterial or fungal infection, hemodynamics instability, deep anemia (Hb \< 8g/dl) or deep thrombocytopenia (\< 20 g/L) despite transfusions, severe hypocalcemia.
- Women in age to procreate without contraception
Exclusion
Key Trial Info
Start Date :
March 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03361254
Start Date
March 31 2020
End Date
September 30 2020
Last Update
January 27 2020
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