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NCT06386302Recruiting

Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

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

Source: ClinicalTrials.gov · Last updated 3 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
184 (estimated)
First submitted
23 Apr 2024
Start date
5 Aug 2024
Primary completion date
30 Dec 2027
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
NCT number
NCT06386302

What you commit to

  • Study type: Interventional
  • Planned participants: 184
  • From 5 Aug 2024 to the primary completion date, 30 Dec 2027
  • 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

  • (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 ;

Other illness

  • (1) Combined with other malignant tumors
  • (6 ) Active infections (including bacterial, fungal or viral infections) and organ bleeding that cannot be controlled clinically;

Other

  • (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;

Who the study is looking for

  • (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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Blood Hospital
Coordinator of this site? Confirm its status
TianjinChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.