The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients.
High-intensity conditioning regimen prior to allogeneic hematopoietic stem cell transplantation (allo-HSCT) can maximize the clearance of leukemia cells, but is often associated with increased pretreatment-related toxicity and transplant-related mortality. In order to enhance its anti-tumor effect without increasing or even decreasing its tissue toxicity, and then prolong the overall survival of AML patients, we optimized the conditioning regimen before allo-HSCT transplantation: (1) The classical Thiotepa/Busulfan/Fludarabine (TBF) regimen will be adopted to reduce the conditioning associated toxicity, ensure graft implantation to the maximum extent and reduce the recurrence rate; ② At the same time, mitoxantrone hydrochloride liposome will be added to avoid the disadvantages of weak immunosuppressive effect and weak anti-leukemia effect, and MTBF pretreatment scheme will be finally explored. It has been applied in the pre-treatment of salvage allo-HSCT in 3 patients with relapsed and refractory acute myeloid leukemia with good safety. Up to the present follow-up time of 4 months, all 3 patients have disease free survival. To evaluate the safety and efficacy of this protocol, we intend to include more patients undergoing salvage allo-HSCT for relapsed or refractory (R/R) AML.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
The subjects will be treated with mitoxantrone hydrochloride liposome combined with thiotepa, busulfan and fludarabine as conditioning regimen prior to allo-HSCT. Mitoxantrone hydrochloride liposome 24mg/m\^2 ivgtt d-7; Ctepide 5mg/kg ivgtt d-6\~-5; Busulfan 0.8mg/kg q6h ivgtt d-4\~-2; Fludarabine 50mg/m\^2 ivgtt d-4\~-2.
Recurrence rate
Disease activity in patients after transplantation
Time frame: 2 years post transplantation
Incidence and Severity of non-hematological adverse events (NCI CTCAE v5.0)
The incidence and severity of non-hematological adverse events were evaluated using NCI CTCAE v5.0 criteria.
Time frame: from the beginning of the conditioning regimen to 2 years post transplantation
Neutrophil recovery time
Peripheral blood neutrophil count (ANC) ≥0.5×10\^9/L for three consecutive days without blood transfusion support
Time frame: 1 month post transplantation
Platelet recovery time
Peripheral blood platelet (PLT) ≥20×10\^9/L for three consecutive days without blood transfusion support.
Time frame: 1 month post transplantation
OS
Overall survival
Time frame: From date of diagnosis until the end of follow-up or the date of death from any couse. Time rage: 6 months post transplantation, 12 months post transplantation.
PFS
Progression-free survival
Time frame: From date of diagnosis until the end of follow-up or disease progression. Time rage: 6 months post transplantation, 12 months post transplantation.
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