The purpose of this study is to assess transplant-related mortality (TRM) at one year after allogeneic hematopoietic stem cell transplantation (allo-HSCT) prepared by a "reduced toxicity myeloablative" conditioning regimen in young patients (children and adolescents) with hematologic malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
* IV fludarabine (30 mg/m²/day for 5 days) * IV Busulfan (Busilvex 3.2 mg/kg/day for 4 days) (the Busulfan dose is to be adapted to the weight of the child according to the drug label) * Anti-thymocyte globulines (Thymogolubuline, 2.5 mg/kg/day for 2 days).
University Hospital
Besançon, France
University Hospital
Bordeaux, France
University Hospital
Clermont-Ferrand, France
Transplant-related mortality (TRM)
Evaluation of the cumulative incidence of TRM at 12 months after transplantation
Time frame: 12 months
Incidence of engraftment
Incidence of engraftment defined as the first day of neutrophil (\>500/μl for 3 consecutive days). Engraftment failure is defined as neutrophil \<500/μl at day+42 after allo-SCT.
Time frame: Day+42
Evaluation of overall (OS) and disease-free survival (DFS)
Evaluation of overall (OS) and disease-free survival (DFS) at 1 year after transplantation
Time frame: 12 months
Cumulative incidence of relapse, death from disease, and non-relapse mortality (NRM)
Cumulative incidence of relapse, death from disease, and non-relapse mortality (NRM)
Time frame: 12 months
Cumulative incidences and severity of acute and chronic Graft-versus-Host disease
Cumulative incidences and severity of acute and chronic Graft-versus-Host disease
Time frame: 12 months
Immune Recovery (to be determined in a subgroup of patients)
Immune Recovery parameters: blood counts, bone marrow aspiration with evaluation of morphological response.
Time frame: 12 months
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University Hospital
Grenoble, France
University Hospital
Lille, France
University Hospital
Lyon, France
University Hospital
Marseille, France
University Hospital
Montpellier, France
University Hospital
Nancy, France
University Hospital
Nantes, France
...and 5 more locations