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NCT07514936RecruitingPhase 3

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

Venetoclax-Azacitidine in Combination With Chidamide and CAG Versus 3+7 Regimen in Fit Older Patients With Acute Myeloid Leukaemia:A Multicenter, Randomized, Controlled, Phase 3 Trial

Source: ClinicalTrials.gov · Last updated 20 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
120 (estimated)
First submitted
21 Nov 2025
Start date
18 Nov 2024
Primary completion date
30 Sept 2027
Lead sponsor
Chinese PLA General Hospital
NCT number
NCT07514936

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 120
  • From 18 Nov 2024 to the primary completion date, 30 Sept 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

  • Patients who have undergone major organ surgery within the last 6 weeks;
  • Patients whom the investigator deems unsuitable for this clinical trial (e.g., poor compliance, drug abuse, etc.).

Other illness

  • Patients who are allergic to the study medication or have contraindications to it;
  • Patients with active infections;
  • Patients with mental disorders or other conditions that prevent obtaining informed consent, or who are unable to cooperate with the treatment and examination procedures;

Lab values

  • 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;

Other

  • Pregnant or breastfeeding women;
  • Patients with long-term smoking or alcohol abuse that could affect the evaluation of trial results;

Who the study is looking for

  • 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.

Age in the registry: 60 years to 75 years · 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
Chinese PLA General Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

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