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Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
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.
Key Details
Gender
All
Age Range
14 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2017-02-08
Completion Date
2027-10-15
Last Updated
2025-05-30
Healthy Volunteers
No
Conditions
Interventions
Cytarabine
Cytarabine at a dose of 3g/㎡/d on the first, third and fifth day.
all-trans retinoic acid
ATRA at a dose of 30mg/㎡/d on day 1-14.
Arsenic Trioxide
ATO at a dose of 10mg/d on day 1-14
Locations (1)
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China