Acute myeloid leukemia is a heterogenous hematological malignancy, characterized by different cytogenetic or molecular features. CEBPA double mutation acute myeloid leukemia (CEBPAdm AML)has favourite prognosis, especially in younger adult patients. But cumulative incidence of relapse of this group patients is still high, so the treatment options need to be optimized urgently.HAD(homoharringtonine(HHT)+cytarabine+daunorubicin) with intermediate dose cytarabine improved the survival of AML, especially in patients with CEBPA double mutation.
In this phase 2 study, 40 patients will be enrolled and treated with HAD induction regimen. High dose cytarabine will be given after complete remission achieved. The primary endpoint was event-free and relapse-free survival. Genetic mutations and measurable residual disease (MRD) will be detected at diagnosis and after chemotherapy. The risk stratification according to genetic mutations and MRD will also be explored. induction chemotherapy:HHT 2mg/m2/d,day 1-7 cytarabine 100mg/m2/d, day1-4;1g/m2 /q12h ,day5-7 DNR 40mg/m2/d,day 1-3 re-induction chemotherapy:IDA 10mg/m2,day 1-3 cytarabine 100mg/m2,day 1-7 CTX 350mg/m2,day 2,day 5 consolidation chemotherapy: high dose cytarabine 3g/m2/Q12h,day1-3,for three cycles
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
daunorubicin,cytarabine,homoharringtonine
HBDH
Tianjin, Tianjin Municipality, China
event free survival
Measured from day 1 of randomization to the date of treatment failure, hematologic relapse from CR or death from any cause, whichever occurs first
Time frame: 5 years
relapse free survival
survival from complete remission to relapse
Time frame: 5 years
complete remission rate
incidence of complete remission after induction chemotherapy
Time frame: 2.5 years
early mortality
death during 30 days from induction chemotherapy
Time frame: 2.5 years
overall survival
duration from enrollment to death or loss of followup
Time frame: 5 years
RFS cencored at stem cell transplantation
RFS cencored at the date of stem cell transplantation
Time frame: 5 years
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