NCT05654194CompletedPhase 3
Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML
A Single Arm Study to Evaluate the Safety and Efficiency of Azacitidine (AZA) Combination With Venetoclax and ATRA in Patients With Newly Diagnosed Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
This is a single arm study to evaluate the safety and efficiency of azacitidine (AZA) combination with venetoclax and ATRA in Patients With Newly diagnosed acute myeloid leukemia. Azacitidine, venetoclax and ATRA, may stop the growth of cancer cells, either by demethylation, by promoting cells differentiation or by killing the cells.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 25 Nov 2022
- Start date
- 31 Oct 2022
- Primary completion date
- 29 Sept 2024
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05654194
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 60
- From 31 Oct 2022 to the primary completion date, 29 Sept 2024
- 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.
Other illness
- Another malignant disease.
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- HIV infection.
Lab values
- Left ventricular ejection fraction \< 0.3 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
Other
- Pregnancy or lactation.
- Acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
- Other commodities that the investigators considered not suitable for the enrollment.
Who the study is looking for
- Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
- Age ≥ 18years.
- ECOG score: 0-3.
- White blood cell count ≤ 25\*10\^9/L
- Total bilirubin ≤ 3X the institutional upper limit of normal if attributable to hepatic infiltration by neoplastic disease
- AST (SGOT) and ALT (SGPT) ≤ 3X the institutional upper limit of normal
- Creatinine clearance ≥30ml/min
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.