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Enrolling by invitationPhase 1/2

Tests arsenic trioxide and tretinoin with chemotherapy in a leukemia type

Tests arsenic trioxide and tretinoin added to chemotherapy in people with NPM1-mutated acute myeloid leukemia.

Plain-language title generated from the registry record
Registry title: Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia

Key facts

Where
Tianjin, ChinaSee the site
Phase
Phase 1/2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 14 to 55 with acute myeloid leukemia (not the APL type) that has an NPM1 gene change and who are in complete remission after first treatment.

Age
14 to 55 years
Sex
All sexes can join
Disease stage
Acute myeloid leukemia (AML), not the APL type, with an NPM1 gene change, in complete remission (CR) after the induction treatment. ECOG score of 2 or lower.
Earlier treatment
Must have reached complete remission after induction treatment. Must not have had radiotherapy or chemotherapy for another tumor in the last 6 months.
Biomarker or test result
NPM1 gene change (mutation). People with the BCR-ABL fusion gene cannot join.

Main reasons for not taking part

  • Secondary leukemia
  • Another tumor that is active, or radiotherapy or chemotherapy for another tumor in the last 6 months
  • Pregnant or breastfeeding women
  • Active heart or blood vessel disease, or poor kidney or liver function
  • AIDS, or severe infection such as untreated tuberculosis or lung aspergillosis

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 14 and 55 years old?

Source: NCT03031249, who can take part

Where in China

  • Institute of Hematology & Blood Diseases HospitalTianjin, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Institute of Hematology & Blood Diseases Hospital, China
Trial code
NCT03031249
Record updated
30 May 2025
Original description
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.Read full original descriptionShow less

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

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.

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

ClinicalTrials.gov NCT03031249