Adding chidamide to venetoclax with azacitidine in untreated acute myeloid leukemia
Tests chidamide with venetoclax and azacitidine in untreated acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia
Key facts
- Where
- Tianjin, ChinaSee the site
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 adults with newly diagnosed acute myeloid leukemia (AML) who cannot have intensive chemotherapy.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed AML (not the M3 type), who cannot have intensive chemotherapy because they are 75 or older, or are 18 to 74 with certain health problems.
- Earlier treatment
- No previous treatment for AML. People who have had chidamide, venetoclax or azacitidine cannot join.
- Biomarker or test result
- Low-risk AML with t(8;21)(q22;q22.1) RUNX1-RUNX1T1, or inv(16)(p13.1q22) or t(16;16)(p13.1;q22) CBFB-MYH11, cannot join.
Main reasons for not taking part
- Another cancer at the same time
- AML that has spread to the brain or spinal cord
- Heart procedure within 12 months, or heart attack, unstable angina or other significant heart disease
- Active infection or organ bleeding that cannot be controlled
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Where in China
- Blood HospitalTianjin, ChinaContact: hui wei, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06386302
- Record updated
- 3 August 2025
- Original description
To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy.Read full original descriptionShow less
A Multicenter, Randomized, Controlled Clinical Trial of Chidamide Combined With Venetoclax and Azacitidine in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) Who Are Not Suitable for Intensive Chemotherapy
To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy.
Inclusion: （1）Age ≥18 years old, no gender limit ; （2）be diagnosed with AML (non-M3) according to WHO 2016 standards; （3）No previous treatment; （4）Ineligible for intensive chemotherapy based on the following definitions: ≥75 years of age or 18 to 74 years of age with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3 A history of cardiac disease such as congestive heart failure Treatment is required, or ejection fraction ≤ 50%, or chronic stable angina, diffusing capacity of lung for carbon monoxide (DLCO) ≤ 65%, or forced expiratory volume in first second (FEV1) ≤ 65%, creatinine clearance ≥ 30 mL/min to < 45 mL/min, moderate hepatic impairment, total bilirubin > 1.5 to ≤ 3.0 × ULN, other comorbidities that are not suitable for intensive chemotherapy in the physician's judgment; （5）Subjects must have an ECOG performance status score of: 0 to 2 for subjects aged ≥ 75 years or 0 to 3 for subjects aged ≥ 18 to 74 years; （6）Other comorbidities that are not suitable for intensive chemotherapy in the doctor's judgment; （7）Expected survival time ≥3 months; （8）Have the ability to understand and be willing to sign the informed consent form for this study.
Exclusion: (2) Have ever received treatment with chidamide and / or venetoclax or azacitidine; (5) Have undergone cardiac angioplasty or stent placement within 12 months before signing the informed consent form , or have a history of myocardial infarction, unstable angina, or other clinically significant heart disease; (8) Participated in any other clinical research within 3 months before signing the informed consent form ; (1) Combined with other malignant tumors; (6 ) Active infections (including bacterial, fungal or viral infections) and organ bleeding that cannot be controlled clinically; (3) The risk is assessed as low risk according to the NCCN 2022 guidelines [t(8;21)(q22;q22.1);RUNX1-RUNX1T1, inv(16)(p13.1q22) or t(16;16 )(p13.1;q22);CBFB-MYH11 ] ; (4) The subject is known to have AML central nervous system (CNS) infiltration; (7) Pregnant or lactating women; (9 ) The researcher believes that it is not suitable to participate in this study.