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Study aim
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Comparison of overall and disease-free survival in "minimal residual disease"-negative leukemia patients receiving a reduced-intensity regimen versus myeloablative regimen as conditioning regimen before hematopoietic stem cell transplantation.
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Design
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A phase 3 randomized controlled clinical trial, with 2 parallel groups, on 84 patients. For randomization, a balanced block randomization list will be used.
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Settings and conduct
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Leukemia patients candidates for allogeneic transplantation in the research institute of Oncology, Hematology and Cell Therapy who are eligible are randomly divided into two groups before transplantation, 1st group receives a reduced intensity conditioning regimen and 2nd group receives a myeloablative regimen before hematopoietic stem cell transplantation. After 1, 3, 6 and 12 months, flow cytometry will be performed to evaluate the minimal residual disease.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Patients from 50 to 65 years old, leukemia patients who are Measurable Residual Disease negative pre-transplant, patient and donor are allowed to be a full match (8/8), acceptable organ function
Exclusion Criteria: prior allogeneic stem cell transplantation, Karnofsky Performance Score < 70, patients with uncontrolled bacterial, viral or fungal infection
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Intervention groups
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Intervention group: (Reduced intensity)
Fludarabine (ACTOVERCO): 30 mg/m2/day day -6 to -2 (before transplantation) and Busulfan (Nanoalvand): 3.2 mg/kg/day IV day -5 to -4;
Control group: (Myeloablative)
Busulfan: 3.2 mg/kg/day IV day -6 to -3 and Cyclophosphamide (Baxter): 60 mg/kg/day IV day -2 to -1 (before transplantation)
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Main outcome variables
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18-month overall survival, disease free survival