NCT03031249Enrolling by invitationPhase 1/2
Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 30 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 12 Jan 2017
- Start date
- 8 Feb 2017
- Primary completion date
- 15 May 2026
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT03031249
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 80
- From 8 Feb 2017 to the primary completion date, 15 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 14 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.