This is a single-center, prospective, exploratory clinical study. It plans to enroll 30 adult patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR1) after induction therapy and meet the indications for allogeneic hematopoietic stem cell transplantation (allo-HSCT). The aim is to evaluate the efficacy and safety of allo-HSCT following conditioning regimens with clofarabine, busulfan and melphalan.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen
2-year Overall Survival(OS)rate
Time frame: 2 years.
1-year Overall Survival(OS)rate
Time frame: 1 year
1-year Relapse-Free Survival(RFS) rate,2-years Relapse-Free Survival(RFS) rate
Time frame: 1-year,2-years
Day 100 non-relapse mortality (NRM) rate after transplantation
Time frame: as the non-relapse mortality at Day 100 post-transplantation.
2-year cumulative incidence of relapse (CIR) after transplantation
Time frame: 2-year
Minimal Residual Disease(MRD) negative conversion rate
Time frame: Bone marrow MRD levels are monitored at 1, 3, 6, 9 and 12 months after hematopoietic stem cell transplantation.
Time to Absolute Neutrophil Count(ANC) engraftment and time to Platelet Count(PLT) engraftment (hematopoietic reconstitution time)
Time frame: Time to ANC engraftment is defined as the first day of sustained absolute neutrophil count ≥ 0.5×10⁹/L for three consecutive days after transplantation. Time to PLT engraftment is defined as the first day of sustained platelet count ≥ 20×10⁹/L for seven
Incidence of Graft-versus-Host Disease(GVHD)
Time frame: The incidences of acute graft-versus-host disease (aGVHD) and severe (Grade III-IV) aGVHD within 100 days after hematopoietic stem cell transplantation, as well as chronic graft-versus-host disease (cGVHD) within 2 years after transplantation.
The severity of adverse events and the number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: From start of treatment to 2 years post-treatment.
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