The purpose of this study is to evaluate whether HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion with venetoclax-containing regimens (microtransplant, MST) could improve survival in adult patients with newly diagnosed acute myeloid leukemia (AML).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital
Beijing, China
RECRUITINGOverall survival (OS)
OS is defined as the number of days from the date of initiation of treatment to the date of death.
Time frame: Measured up to 4 years after the last participant is enrolled
Event-free Survival (EFS)
EFS is defined as the number of days from initiation of treatment to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause.
Time frame: Measured up to 4 years after the last participant is enrolled
Complete remission (CR) and complete remission with incomplete marrow recovery (CRi)
CR is defined as absolute neutrophil count \> 1 × 109/L, platelet count \> 100 × 109/L, red cell transfusion independence, and bone marrow with \< 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophil count \<= 1 × 109/L or platelet count \<= 100 × 109/L.
Time frame: Measured up to 2 years after the last participant is enrolled
Partial remission (PR)
PR is defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow, peripheral blood neutrophil count \> 1 × 109/L, platelet count \> 100 × 109/L, red cell transfusion independence.
Time frame: Measured up to 2 years after the last participant is enrolled
Non-relapse Mortality (NRM)
NRM is defined as the death without relapse.
Time frame: Measured up to 4 years after the last participant is enrolled
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Given IV
Given IV
HLA-mismatched donor GPBMC infusion