To improve the 2 year overall survival in patients with acute myeloid leukaemia (AML) in primary treatment failure
Conditions
Interventions
Trade Name: Evoltra
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Aracytine
Pharmaceutical Form: Powder for solution for infusion
Trade Name: cyclophosmamide
Pharmaceutical
Sponsors
CHU de Nantes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Confirmed diagnosis of AML in the status of primary induction failure (i.e. persistent leu-kemia after 2 courses of induction chemotherapy or persisting bone marrow hypoplasia fol-lowing induction chemotherapy +/-minimal residual disease) OR AML with cytogenetic or hematological relapse within 6 months from documentation of first complete remission. - Age: 18-65 years. - Availability of an HLA identical family donor OR unrelated donor with matching in 10/10 alleles (HLA-A, B, C, DRB1, DQB1) or maximum of 1 allele or antigen mismatch OR family donor with maximum 1 allele mismatch. - Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Documented chloroma - Documented leukemic infiltration of CNS/cerebrospinal fluid - Karnofsky performance score below 4x the upper limit of normal) - HIV infection, chronic viral hepatitis - Severe neurological or psychiatric disorders - Any circumstances that provide the use of the drugs used within the protocol - Prior allogeneic or autologous stem cell transplantation - > 3 courses of prior chemotherapy - Denied informed consent - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To improve the 2 year overall survival in patients with primary treatment failure;Secondary Objective: Leukemia-free survival (LFS) at 2 years from transplantation - Leukemia response rate at day +30, +90, 6, 12 and 24 months after allo-SCT - Cumulative incidence of relapse, death from leukemia, and non-relapse mortality (NRM) - Incidence and severity of acute and chronic graft-versus-host disease (GVHD) - Feasibility and safety of early discontinuation of immunosuppressive therapy - Feasibility and safety of performing prophylactic donor lymphocytes infusion (pDLI) ;Primary end point(s): | — |
Countries
France
Outcome results
None listed