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| ID | Type | Description | Link |
|---|---|---|---|
| PSS2017/PCE-aGVHD-RUBIO/VS | Other Identifier | CHRU Nancy |
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Acute graft versus host-disease remains a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. The incidence of grade II to IV acute GVHD ranges from 30 to 50% of the patients transplanted. Steroids remain the standard first line treatment for acute GVHD.
Prolonged exposure to steroids is associated to increased risk of infections and of osteoporosis, osteonecrosis and alteration of growth in children. Thus, reducing steroid exposure in order to reduce treatment-related morbidity is another important goal in the management of standard risk aGVHD.
Extracoporeal photopheresis (ECP) is active in controlling steroid refractory or dependent acute GVHD.
Hypothesis:
In this study, the team hypothesizes that addition of ECP to first line treatment with 2 mg/kg steroids of standard risk grade II aGVHD can reduce steroid exposure by increasing the probability of 6 month FFTF including absence of systemic steroids for chronic GVHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | corticosteroids + ECP |
|
| ContrĂ´l group | Active Comparator | corticosteroids alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxsalen + ECP device | Combination Product | 2 sessions per week during 4 weeks and 1 session per week during 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Probability of being free of treatment failure (probability of survival without relapse, additional line of treatment for aGVHD and systemic therapy for chronic GVHD) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| mean of the cumulative dose of steroids | Month 1- Month 2 - Month 3 - Month 6 - Month 12 | |
| cumulative incidence rate of infections | Month 6 - Month 12 | |
| cumulative incidence of thromboembolic complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Thérèse RUBIO, PU-PH | Contact | 0383153282 | m.rubio@chru-nancy.fr |
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| Corticosteroids | Drug | 2 mg/kg/day |
|
| Month 3 |
| incidence of chronic GVHD | Month 6 - Month 12 |
| severity of chronic GVHD | Month 6 - Month 12 |
| incidence rate of non-relapse mortality | Month 6 - Month 12 |
| incidence of disease relapse | Month 6 - Month 12 |
| disease-free survival | Month 6 - Month 12 |
| overall survival | Month 6 - Month 12 |
| scores of health-related quality of life using the French validated FACT-BMT | Month 3 - Month 6 - Month 12 |
| Total T cells number | Month 3 - Month 6 - Month 12 |
| CD4 T cells number | Month 3 - Month 6 - Month 12 |
| CD8 T cells number | Month 3 - Month 6 - Month 12 |
| B cells number | Month 3 - Month 6 - Month 12 |
| NK cells number | Month 3 - Month 6 - Month 12 |
| gamma globulin number | Month 3 - Month 6 - Month 12 |
| ID | Term |
|---|---|
| D008730 | Methoxsalen |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D011564 | Furocoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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