Adults patients will be included in the hematology departments. Eligible patients will be those scheduled to receive an allo-HSC after a RIC conditioning regimen for a myeloid or lymphoid hematological malignancy with a family or non-family HLA-matched donor 10/10
Conditions
Brief summary
The incidence of corticoresistant grade 3 and 4 acute GVH following allo-HSC according to Mount Sinai criteria. Corticoresistance is assessed according to the criteria of Mohty et al and defined as either -> after 5 to 7 days of 2 mg/kg systemic corticosteroids: worsening or non-improvement of GVH -> after 14 days of 2 mg/kg systemic corticosteroids: absence of complete remission of GVHD. Corticoresistant acute GVH following DLI injection will be excluded
Detailed description
Graft uptake assessed on hematological reconstitution (number of days of aplasia with PNN <0.5 G/L and platelets < 20, number of platelet and red cell concentrate transfusions), OS at 1 year and last follow-up (survival between day 0 of transplantation and date of death or last follow-up), DFS at 1 year and last follow-up (survival from day 0 of transplantation to date of relapse, death or last follow-up), GRFS at 1 year and last follow-up (relapse-free survival without grade 3-4 acute GVH or chronic GVH requiring systemic treatment), Acute GVHD grade 2-4 according to Mount Sinai criteria, Chronic GVHD according to NCI criteria, NRM: any death unrelated to relapse or disease progression at 1 year and last follow-up, Relapse: any documented disease recurrence at 1 year and last follow-up, Total donor or mixed chemism at M1, M2, M3, M6, M12. Total donor chimerism = result >95% donor CD3+ and CD34+ cells. Mixed chimerism = result > 5% and < 95% donor CD3+ cells (routine test), Immune reconstitution at M3, M6, M9, M12: lymphocyte, monocyte, T4, T8, NK and B cell counts (routine examination), Grade 3 and 4 post-transplant adverse events (dates of occurrence) (NCI CTCAE version 5 criteria), Infections: viral (CMV, EBV, BKV, adenovirus), bacteriological, fungal and parasitic
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of corticoresistant grade 3 and 4 acute GVH following allo-HSC according to Mount Sinai criteria. Corticoresistance is assessed according to the criteria of Mohty et al and defined as either -> after 5 to 7 days of 2 mg/kg systemic corticosteroids: worsening or non-improvement of GVH -> after 14 days of 2 mg/kg systemic corticosteroids: absence of complete remission of GVHD. Corticoresistant acute GVH following DLI injection will be excluded | — |
Secondary
| Measure | Time frame |
|---|---|
| Graft uptake assessed on hematological reconstitution (number of days of aplasia with PNN <0.5 G/L and platelets < 20, number of platelet and red cell concentrate transfusions), OS at 1 year and last follow-up (survival between day 0 of transplantation and date of death or last follow-up), DFS at 1 year and last follow-up (survival from day 0 of transplantation to date of relapse, death or last follow-up), GRFS at 1 year and last follow-up (relapse-free survival without grade 3-4 acute GVH or chronic GVH requiring systemic treatment), Acute GVHD grade 2-4 according to Mount Sinai criteria, Chronic GVHD according to NCI criteria, NRM: any death unrelated to relapse or disease progression at 1 year and last follow-up, Relapse: any documented disease recurrence at 1 year and last follow-up, Total donor or mixed chemism at M1, M2, M3, M6, M12. Total donor chimerism = result >95% donor CD3+ and CD34+ cells. Mixed chimerism = result > 5% and < 95% donor CD3+ cells (routine test), Immune reco | — |
Countries
France