In this open-label, randomized, prospective clinical trial, nucleophosmin-1(NPM1) mutated acute myeloid leukemia (AML) patients who have reached CR are randomized into two groups.The control group receive high-dose cytarabine(HDAC) regimen while the experimental group receive high dose of cytarabine plus tretinoin(ATRA) and arsenic trioxide(ATO) treatment.The safety and efficacy of ATRA and ATO is evaluated.
In this open-label, randomized, prospective clinical trial, NPM1- mutated AML patients who have reached CR are randomized into two groups. In experimental group, patients receive cytarabine at a dose of 3g/㎡/d on the first, third and fifth day, ATRA at a dose of 30mg/㎡/d on day 1-14 and ATO at a dose of 0.15mg/kg/d (maximum, 10mg/d) on day 1-14. Patients in control group only receive high dose of cytarabine. The safety and efficacy of ATRA plus ATO regimen is evaluated.The primary outcome is relapse-free survival rate after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Cytarabine at a dose of 3g/㎡/d on the first, third and fifth day.
ATRA at a dose of 30mg/㎡/d on day 1-14.
ATO at a dose of 10mg/d on day 1-14
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Relapse-Free Survival Rate (RFS)
RFS is defined as the time from the date of complete remission (CR) after entry in this trial until the date of documented relapse or death for NPM1 mutated leukemia patients who achieve CR.
Time frame: Within 5 years after randomization
Non-relapse Mortality
Time frame: through treatment completion, an average of 5 months
Overall Survival Rate (OS)
Time frame: Within 5 years after randomization
Cumulative incidence of relapse
Time frame: Within 5 years after randomization
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