AML Clinical Trial
Official title:
Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
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