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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The aim of this trial is to evaluate the efficacy of GVH prophylaxis reinforced by low-dose Thymoglobulin administered at the end of aplasia after haploidentical allogeneic transplantation.
Patients will receive a single infusion of Thymoglobulin at a dose of 1 mg/kg between 48h and 72h after emergence from aplasia, and will be followed for 12 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin Injectable Product | Drug | single intravenous injection of thymoglobulin |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of acute GVH | To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification. | Day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute GVH | Grade 2-4 acute GVHD will be assessed using the MAGIC classification post allograft | day(D) 30, D60, D90, D100, D120, D180, D270 and D365 |
| chronic GVH | Chronic GVHD will be assessed using NIH classification post allograft, |
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Inclusion Criteria:
Adults aged ≥ 60 or aged 50 to 59 with comorbidities (HCT-CI10 score ≥ 3),
Hematological malignancies except myeloproliferative syndrome and myelodysplastic syndrome,
Patient having received an allograft within ≤ 35 days, performed with the following modalities:
Patient discharged from aplasia within ≤ 35 days,
Signed informed consent form,
Affiliation with a social security.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihane PAKRADOUNI | Contact | +33491223778 | drci.up@ipc.unicancer.fr |
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| day(D)100, D120, D180, D270 and D365 |
| Cumulative incidence of chronic GVH | Cumulative incidence of chronic GVHD at 1 year post-transplant, | 1 year |
| Cumulative incidence of NRM | Cumulative incidence of NRM at 1 year post-transplant, | 1 year |
| Cumulative incidence of relapse | Cumulative incidence of relapse at 1 year post-transplant, | 1 year |
| Immunology | Blood T, B and NK lymphocyte counts post-transplant, | day(D)100, D120, D180, D270 and D365 |
| Viral infections | Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) post allograft, | between day (D)30 and D120 |
| Cumulative incidence | Cumulative incidence of EBMT-defined "poor graft function" post-transplant. | Day 100 |
| Survival | Progression-free survival and overall survival at 1 year post-transplant, | 1 year |
| 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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