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Clinical Trials in China / NCT03031249
Enrolling by invitation Phase 1/2

Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia

NCT03031249 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 1/2
Started
2017-02-08
Last updated
2025-05-30

Condition(s) studied

AML

Investigational drug(s) / intervention(s)

Cytarabine →all-trans retinoic acid →Arsenic Trioxide →

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

Study 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.

Eligibility

Sex
ALL
Min age
14 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age of 14 to 55 years old; 2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes) and with NPM1-mutated. 3. Reached CR after induction regimen. 4. ECOG score of ≤ 2; 5. Patients with eligible laboratory examination including liver,renal and heart function. 6. Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent. Exclusion Criteria: 1. Secondary leukemia. 2. Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor. 3. Patients with other blood diseases(for example, haemophiliacs) are excluded.However, patients with abnormal blood count, but with undiagnosed MDS or MPD patients are included. 4. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients; 5. With BCR-ABL fusion gene; 6. Pregnant or lactating women; 7. With ineligible renal or liver function; 8. With active cardiovascular disease; 9. Severe infection disease including uncured tuberculosis pulmonary aspergillosis; 10. AIDS; 11. Patients had central nervous system involvement when they were diagnosed as AML. 12. Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research. 13. Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results. 14. Patients with other factors which were considered unsuitable to participate in the study by the investigators.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology & Blood Diseases Hospital Tianjin Tianjin Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03031249 on ClinicalTrials.gov ↗ ← All trials in China