Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.
The optimal therapy for intermediate-risk patients with acute myeloid leukemia (AML) in first complete remission (CR1) is uncertain. Recent studies shown that microtransplantation (MST) can improve survival in AML-CR1 patients. However, a comparison study between the MST and nonmyeloablative stem cell transplantation (NST) is lacking. 156 intermediate-risk AML-CR1 patients aged 9 to 59 years were enrolled in this study. Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
HLA mismatched donor G-CSF mobilized peripheral stem cell infused 24 hours (day 0) after the completion of chemotherapy
HLA matched donor G-CSF mobilized peripheral stem cell infused after the conditioning reginmen
The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
Affiliated Hospital of Academy of Military Medical Sciences ,
Beijing, Beijing Municipality, China
Overall Survival
Time frame: 10 years
treatment-related mortality
Time frame: 2 years
donor chimerism or microchimerism
Time frame: 10 years
WT1+CD8+CTL
donor versus leukemia effect
Time frame: 10 years
GVHD
Time frame: 10 years
disease free survival
Time frame: 10 years
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The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose
30 mg/m2/d for 5days
1.5-2 mg/kg/d for 4 days
40 mg/kg/d for 2 days