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NCT Number: NCT07514936

Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia

This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard "3+7" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chinese PLA General Hospital

Beijing, None Selected, 100853, China

Location status: Recruiting

Location contact

Liping Dou

CONTACT

[email protected]

+8613681207138

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary participation in the clinical study; the subject or legal guardian fully understands and is informed about the study and has signed the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures;
  • Age between 60-75 years at the time of screening, with no gender restrictions;
  • Patients are newly diagnosed with AML, and the diagnosis conforms to the standards of the Chinese Medical Association 2021 edition;
  • No severe allergic constitution;
  • Liver function: ALT and AST <= 2.5 times the upper limit of normal values, bilirubin <= 2 times the upper limit of normal values;
  • Renal function: creatinine <= upper limit of normal values;
  • No uncontrollable infections or severe mental illnesses;
  • Performance status score is 0-3 (ECOG), with an expected survival of at least 4 months.

Exclusion criteria

  • Patients who are allergic to the study medication or have contraindications to it;
  • Pregnant or breastfeeding women;
  • Patients with active infections;
  • Patients with long-term smoking or alcohol abuse that could affect the evaluation of trial results;
  • Patients with mental disorders or other conditions that prevent obtaining informed consent, or who are unable to cooperate with the treatment and examination procedures;
  • Patients who have undergone major organ surgery within the last 6 weeks;
  • Abnormal liver function, with total bilirubin > 1.5 times the upper limit of normal, ALT/AST > 2.5 times the upper limit of normal, or liver-infiltrated patients with ALT/AST > 5 times the upper limit of normal; abnormal renal function, with serum creatinine > 1.5 times the upper limit of normal;
  • Patients whom the investigator deems unsuitable for this clinical trial (e.g., poor compliance, drug abuse, etc.).

Treatment and study plan

the standard "3+7" regimen

Drug

IA Regimen:

Idarubicin: 8-12 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.

Or DA Regimen:

Daunorubicin: 60 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.

Or MA Regimen:

Mitoxantrone: 6-10 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.

Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte

Drug

IA Regimen:

Idarubicin: 8-12 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.

Or DA Regimen:

Daunorubicin: 60 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.

Or MA Regimen:

Mitoxantrone: 6-10 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.

Primary outcomes

  1. Composite Complete Remission (CRc) Rate after 1 course of treatment

    Time frame: 1 months after study treatment

    a combination of complete remission (CR) and complete remission with incomplete blood count recovery (CRi)

Secondary outcomes

  1. Overall Response Rate (ORR) after 1 course of treatment

    Time frame: 1 months after the start of study treatment

    Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq. Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis.

  2. Complete Remission (CR) Rate after 1 courses of treatment

    Time frame: after 1 courses of chemotherapy (each course is 28 days)

    Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 10^9/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions.

  3. Rate of Minimal Residual Disease (MRD)-Negative Response

    Time frame: after each courses of chemotherapy (each course is 28 days)

    Percentage of participants who achieved MRD-negative response, defined as < 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry after each courses of chemotherapy (each course is 28 days)

  4. Event-free survival

    Time frame: 180 days after study treatment

    Defined as the time interval from treatment initiation to the occurrence of induction failure,relapse,or death,whichever came first.

  5. Overall Survival

    Time frame: 180 days after study treatment

    Defined as the time from joining the clinical study to death due to any cause.

  6. Treatment-related adverse events

    Time frame: From the first dose of study treatment to 30 days after the discontinuation of treatment

    Defined as adverse events that occurred from the first dose of study treatment to 30 days after the discontinuation of treatment.

  7. Disease-free survival

    Time frame: 180 days after study treatment Outcome Measure

    Defined as the time interval from disease remission to the occurrence of relapse or death,whichever came first.

  8. Early death

    Time frame: Within 30 days of the start of the first course of treatment

    Defined as death within 30 days of chemotherapy.

  9. Complete Remission with Incomplete Blood Count Recovery (CRi)after 1 courses of treatment

    Time frame: after 1 courses of chemotherapy (each course is 28 days

    Disappearance of leukemia blasts in the bone marrow (<5% blasts) but without full recovery of blood counts (neutrophils <1.0 x 10⁹/L and/or platelets <100 x 10⁹/L).

Study contacts

Contact information is provided by the study sponsor or research team.

Dahong Liu Liu, doctor

CONTACT

[email protected]

+8613681171597

Liping Dou, Doctor

CONTACT

[email protected]

+8613681207138

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • 940 Hospital of the People's Liberation Army Joint Logistic Support Force
  • 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
  • First Affiliated Hospital of Harbin Medical University
  • The General Hospital of Western Theater Command

Registry information

Official study title

Venetoclax-Azacitidine in Combination With Chidamide and CAG Versus Daunorubicin and Cytarabine in Fit Older Patients With Acute Myeloid Leukaemia:A Multicenter, Randomized, Controlled, Phase 3 Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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