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Enrolling by invitation NCT03031249

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

Phase I / Phase II Interventional AML

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cytarabine, all-trans retinoic acid, Arsenic Trioxide.
Who it may be relevant to
Registry conditions: AML. Basic parameters: 14 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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.

Interventions

  • Drug Cytarabine
    Cytarabine at a dose of 3g/㎡/d on the first, third and fifth day.
  • Drug all-trans retinoic acid
    ATRA at a dose of 30mg/㎡/d on day 1-14.
  • Drug Arsenic Trioxide
    ATO at a dose of 10mg/d on day 1-14

Primary outcome measures

  • Relapse-Free Survival Rate (RFS) [Time frame: Within 5 years after randomization]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Institute of Hematology & Blood Diseases Hospital — Tianjin

Identifiers

NCT: NCT03031249 · IIT2016007（ATO + ATRA）

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗