Actively Recruiting

Phase 2
Age: 60Years - 75Years
All Genders
NCT07514936

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

Led by Chinese PLA General Hospital · Updated on 2026-04-07

120

Participants Needed

1

Research Sites

162 weeks

Total Duration

On this page

Sponsors

C

Chinese PLA General Hospital

Lead Sponsor

9

940 Hospital of the People's Liberation Army Joint Logistic Support Force

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 60Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agree to participate and sign informed consent
  • Age between 60 and 75 years
  • Newly diagnosed with Acute Myeloid Leukemia according to 2021 Chinese Medical Association standards
  • No severe allergy history
  • Liver function with ALT and AST ≤ 2.5 times upper normal limit and bilirubin ≤ 2 times upper normal limit
  • Normal renal function with creatinine ≤ upper normal limit
  • No uncontrollable infections or severe mental illnesses
  • Performance status score 0-3 (ECOG) and expected survival of at least 4 months
Not Eligible

You will not qualify if you...

  • Allergy or contraindication to study medications
  • Pregnant or breastfeeding women
  • Active infections
  • Long-term smoking or alcohol abuse affecting trial evaluation
  • Mental disorders or inability to cooperate with treatment and examinations
  • Major organ surgery within last 6 weeks
  • Abnormal liver function with bilirubin > 1.5 times upper normal limit or ALT/AST > 2.5 times upper normal limit, or liver infiltration with ALT/AST > 5 times upper normal limit
  • Abnormal renal function with creatinine > 1.5 times upper normal limit
  • Investigator judgment of unsuitability (e.g., poor compliance, drug abuse)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chinese PLA General Hospital

Beijing, None Selected, China, 100853

Actively Recruiting

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Research Team

D

Dahong Liu Liu, doctor

CONTACT

L

Liping Dou, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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