ECP will be given to the patients \[UVAR®XTS TM Therakos system, Johnson \& Johnson\] according to the following schedule: Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the first 2 weeks, and 1 ECP per week during 1 month. Total = 8 ECP after transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
20
UVADEX® is supplied in a 10 mL single-use vial. Each mL of solution contains 20 mcg of UVADEX®. In the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button. The dose of UVADEX used to inoculate these cells will be calculated based on the treatment volume collected during the plasma/buffy coat collection process, usinge the following formula : Treatment Volume in mL x 0.017 = Dose of UVADEX® (in mLs) required for administration into the recirculation bag. After the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient.
In the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporeal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button. After the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient.
Centre de Santé - Etablissement Français du Sang (EFS)
Lyon, France
ACTIVE_NOT_RECRUITINGHôpital Edouard Herriot, Service d'Hématologie
Lyon, France
RECRUITINGEvaluation of the toxicity at Day 100 (NCI/NIH Common Toxicity Criteria) of Extracorporal Photopheresis (ECP) administered for Graft-versus-host-disease (GVHD) prophylaxis and introduced early (Day 21) after an HSCT from a genoidentical donor.
All types of toxicity will be assessed and graded according to NCI/NIH Common Toxicity Criteria
Time frame: Day 100
Efficacy: decrease in incidence of acute GVHD and chronic GVHD
Time frame: during 2 years
Incidence of Infection (clinically et/or bacteriologically proved)
Time frame: during 2 years
Documentation of chimerism [quantification of donor-type chimerism in bone marrow and/ or in peripheral blood (total blood, CD3+)]
Time frame: during 2 years
Transplant-related Mortality
TRM at 3 months for acute GVHD and at 1 year for chronic GVHD
Time frame: at 3 months and 1 year
Toxicity at Day 180 after HSC transplantation
Time frame: Day 180
Disease-free survival (DFS)
Time frame: at 1 and 2 years
progression-free survival (PFS)
Time frame: at 1 and 2 years
Overall survival (OS)
Time frame: at 1 and 2 years
cumulative incidence of relapse
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Time frame: at 1 and 2 years