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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
27
single intravenous injection of thymoglobulin
Rate of acute GVH
To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification.
Time frame: Day 100
Acute GVH
Grade 2-4 acute GVHD will be assessed using the MAGIC classification post allograft
Time frame: day(D) 30, D60, D90, D100, D120, D180, D270 and D365
chronic GVH
Chronic GVHD will be assessed using NIH classification post allograft,
Time frame: day(D)100, D120, D180, D270 and D365
Cumulative incidence of chronic GVH
Cumulative incidence of chronic GVHD at 1 year post-transplant,
Time frame: 1 year
Cumulative incidence of NRM
Cumulative incidence of NRM at 1 year post-transplant,
Time frame: 1 year
Cumulative incidence of relapse
Cumulative incidence of relapse at 1 year post-transplant,
Time frame: 1 year
Immunology
Blood T, B and NK lymphocyte counts post-transplant,
Time frame: day(D)100, D120, D180, D270 and D365
Viral infections
Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) post allograft,
Time frame: between day (D)30 and D120
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Cumulative incidence
Cumulative incidence of EBMT-defined "poor graft function" post-transplant.
Time frame: Day 100
Survival
Progression-free survival and overall survival at 1 year post-transplant,
Time frame: 1 year