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

NCT07514936 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-07

No results posted yet for this study

Summary

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

  • Newly Diagnosed Acute Myeloid Leukemia (AML)
  • Elderly Patients

Interventions

DRUG

the standard "3+7" regimen

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.

DRUG

Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte

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.

Sponsors & Collaborators

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

    collaborator OTHER

  • The General Hospital of Western Theater Command

    collaborator OTHER

  • First Affiliated Hospital of Harbin Medical University

    collaborator OTHER

  • The 960th Hospital of the PLA Joint Logistics Support Force

    collaborator UNKNOWN

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Dahong Liu, Doctor · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2027-12-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07514936 on ClinicalTrials.gov