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.
The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up;
Age 18-65 years old (including upper and lower limits);
No gender limitation
Relapsed or refractory (R/R) acute myeloid leukemia can not achieve complete remission by chemotherapy, and has the indication of salvage allogeneic hematopoietic stem cell transplantation.
Hypersensitivity to any investigational drug or its components;
Uncontrolled systemic diseases (e.g. active infections, uncontrolled hypertension, diabetes, etc.)
Long QTc syndrome or QTc interval>480 ms;
Complete left bundle branch block, II or III degree atrioventricular block;
Single group
MTBF regimen
DrugThe 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
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.
Neutrophil recovery time
Peripheral blood neutrophil count (ANC) ≥0.5×10\^9/L for three consecutive days without blood transfusion support
Platelet recovery time
Peripheral blood platelet (PLT) ≥20×10\^9/L for three consecutive days without blood transfusion support.
OS
Overall survival
aGVHD
The incidence of acute graft versus host disease
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
