The investigators will conduct this prospective and randomized clinical trial, to evaluate the hematopoietic reconstitution, GVHD and relapse rate of patients after allo-HSCT with decitabine containing conditional regimen and NAC treatment.
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the main curative treatment for hematological malignancy. Relapse, graft versus host disease (GVHD) and graft failure are the main causes of treatment failure. Acetylcysteine (NAC) was found to be able to enhance defective HSCs by repairing dysfunctional bone marrow endothelial cells, and overcome the exhaustion of HSCs and enhance the engraftment of HSCs. Decitabine could restore bone marrow microenvironment by repairing endothelial cells and endothelial progenitor cells, as well as cytokines and chemokines which are crucial to HSCs proliferation and differentiation, thereby promote platelet recovery after HSCT. Besides, decitabine therapy was shown to be associated with reduced incidence of GVHD, lower relapse rate, and increased overall survival in several studies. Thereby the investigators will conduct this clinical trial to evaluate the hematopoietic reconstitution, GVHD and relapse rate of patients with hematological malignancy after allo-HSCT with decitabine containing conditional regimen and NAC treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Decitabine (20mg/m2 intravenously from day -10 to day -8 of conditional regimen)
Acetylcysteine: 1.2g twice a day, oral administration, from day -10 to day 365 after HSCT.
Semustine: 250 mg/m2/day on day -9.
The hematological engraftment rates
The hematological engraftment rates of patients after HSCT.
Time frame: 1 year
GVHD rates
The GVHD rates of patients after HSCT.
Time frame: 1 year
Relapse rates
The relapse rates of patients after HSCT.
Time frame: 1 year
Overall survival
To evaluate the overall survival (days) of patients after HSCT.
Time frame: 1 year
Disease free survival
To evaluate the disease free survival (days) of patients after HSCT.
Time frame: 1 year
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Cytarabine: 2 g/m2 every 12 hours on day -8.
Busulfan: 3.2mg/kg/day on day -7 to -5.
Cyclophosphamide: 1.8g/m2/day on day -4 to -3.
Cyclosporin A: 3mg/kg/d from day -8.
Anti-thymocyte globulin (2mg/kg/d on day -5 to day -2) will be added for transplants with unrelated donor or HLA mismatched donor.
Mycophenolate (500mg, oral, twice a day from day -8) will be added for transplants with unrelated donor or HLA mismatched donor.