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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2022
  • participants needed
    80
  • sponsor
    Institute of Hematology & Blood Diseases Hospital
Updated on 24 January 2021
cytarabine
tretinoin

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.

Description

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.

Details
Condition Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment cytarabine, Arsenic trioxide, All-trans retinoic acid
Clinical Study IdentifierNCT03031249
SponsorInstitute of Hematology & Blood Diseases Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age of 14 to 55 years old
Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes) and with NPM1-mutated
Reached CR after induction regimen
ECOG score of 2
Patients with eligible laboratory examination including liver,renal and heart function
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

Secondary leukemia
Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor
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
Acute panmyelosis with myelofibrosis and myeloid sarcoma patients
With BCR-ABL fusion gene
Pregnant or lactating women
With ineligible renal or liver function
With active cardiovascular disease
Severe infection disease including uncured tuberculosis pulmonary aspergillosis
AIDS
Patients had central nervous system involvement when they were diagnosed as AML
Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research
Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results
Patients with other factors which were considered unsuitable to participate in the study by the investigators
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