The present trial will establish a prospective sequential Allogeneic Stem Cell Transplantation (allo-SCT) treatment combining both salvage chemotherapy and Reduced Intensity Conditioning (RIC) for primary treatment failure Acute Myeloid Leukemia (AML), to which future innovative strategies can be compared.
Primary Endpoint: To improve the 2 year overall survival in patients with primary treatment failure \* Secondary Endpoints: * Feasibility of early transplantation within a multicenter trial * Leukemia-free survival (LFS) at 2 years from transplantation * Leukemia Response rate at day +30, +90 and 6 months * Cumulative incidence of relapse, death from leukemia, and non-relapse mortality (NRM) * Incidence and severity of acute and chronic Graft-versus-Host disease * Feasibility and safety of early discontinuation of immunosuppressive therapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
The present protocol aims to test the strategy of an early Reduced Intensity Conditioning (RIC) allo-SCT; in combination with a sequential preparative regimen for allo-SCT (Clofarabine, Intermediate dose Ara-C chemotherapy, followed by RIC with Cyclophosphamide, IV Busulfan and ATG; and delayed prophylactic infusion of donor lymphocytes (DLI) will be able to improve the outcome of patients with primary treatment failure AML.
CHU de Bordeaux
Bordeaux, France
CHU Caen
Caen, France
CHRU lille
Lille, France
Hôpital Edouard Herriot
Lyon, France
Evaluation of the survival rate at 2 years after transplantation
Time frame: at 2 years after transplantation
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Institut Paoli Calmette
Marseille, France
Nantes University hospital
Nantes, France
Paris saint Louis
Paris, France
CHRU de Strasbourg
Strasbourg, France
CHU Toulouse
Toulouse, France