The goal of this study is to evaluate the efficacy and safety of a conditioning regimen of Mitoxantrone Hydrochloride Liposome in combination with Bu/Cy (M+Bu/Cy) on acute myeloid leukaemia (AML) patients with intermediate/adverse risk disease or persistently positive MRD undergoing allogeneic haematopoietic stem-cell transplantation (allo-HSCT)
The goal of this study is to evaluate the efficacy and safety of a conditioning regimen of Mitoxantrone Hydrochloride Liposome in combination with Bu/Cy (M+Bu/Cy) on acute myeloid leukaemia (AML) patients with intermediate/adverse risk disease or persistently positive MRD undergoing allogeneic haematopoietic stem-cell transplantation (allo-HSCT Mitoxantrone Hydrochloride Liposome combined with BU/Cy were used as a conditioning regimen for patients with intermediate/adverse risk or persistently positive MRD AML. Mitoxantrone hydrochloride liposome (30 mg/m\^2) on day -9, iv Busulfan (3.2mg/kg/d) on day -7\~-5, iv Cyclophosphamide (60 mg/kg/d) on day -3\~-2, iv
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Mitoxantrone hydrochloride liposome (30 mg/m\^2) on day -9, iv Busulfan (3.2mg/kg/d) on day -7\~-5, iv Cyclophosphamide (60 mg/kg/d) on day -3\~-2, iv
1 year-relapsed free survival (1y-RFS)
RFS was defined as time from achieving remission until disease relapse or disease progression.
Time frame: 1YEAR
1 year-overall survival (1y-OS)
OS was defined as time from conditioning treatment until death from any cause.
Time frame: 1YEAR
1 year-non-relapse mortality (1y-NRM)
NRM was defined as death from any cause not subsequent to relapse or disease progression.
Time frame: 1YEAR
1 year-cumulative incidence of relapse (1y-CIR)
CIR was defined as time from conditioning treatment until relapse or disease progression.
Time frame: 1YEAR
Time of neutrophil and platelet engraftment
Neutrophil engraftment was defined as the first of 3 consecutive days with absolute neutrophil counts exceeding 0.5×109 cells per L, and platelet engraftment as the first of 3 consecutive days with absolute platelet counts exceeding 20×109 platelets per L without a platelet transfusion.
Time frame: 8 weeks
Complete response (CR) rate
CR rate was defined as bone marrow blasts less than 5% with normal maturation of all cell lines, absence of circulating blasts and blasts with Auer rods, absence of extramedullary disease, and absolute neutrophil count ≥1×109 cells per L, platelet count ≥100×109 platelets per L.
Time frame: 1YEAR
Incidence of adverse events
Adverse events were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0) except for GVHD; aGVHD and cGVHD were graded according to published guidelines.
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Time frame: 14 weeks
Regimenrelated toxicity (RRT)
RRT was assessed within 28 days after transplantation and graded according to Bearman's criteria.
Time frame: 4 weeks