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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracorporal Photopheresis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxsalen | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation 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 | Day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: decrease in incidence of acute GVHD and chronic GVHD | during 2 years | |
| Incidence of Infection (clinically et/or bacteriologically proved) | during 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mauricette Michallet, Professor | Contact | +33472117402 | mauricette.michallet@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mauricette Michallet, Professor | Hospices Civils de Lyon | Principal Investigator |
| Olivier Hequet, MD | Etablissement Français du Sang | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Santé - Etablissement Français du Sang (EFS) | Active, not recruiting | Lyon | 69003 | France | ||
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D008730 | Methoxsalen |
| ID | Term |
|---|---|
| D011564 | Furocoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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|
|
| Extracoporal Photopheresis (ECP) | Procedure | 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. |
|
|
| Documentation of chimerism [quantification of donor-type chimerism in bone marrow and/ or in peripheral blood (total blood, CD3+)] |
| during 2 years |
| Transplant-related Mortality | TRM at 3 months for acute GVHD and at 1 year for chronic GVHD | at 3 months and 1 year |
| Toxicity at Day 180 after HSC transplantation | Day 180 |
| Disease-free survival (DFS) | at 1 and 2 years |
| progression-free survival (PFS) | at 1 and 2 years |
| Overall survival (OS) | at 1 and 2 years |
| cumulative incidence of relapse | at 1 and 2 years |
| Hôpital Edouard Herriot, Service d'Hématologie |
| Recruiting |
| Lyon |
| 69003 |
| France |
|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |