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

NCT07514936 | Recruiting Phase 2 DMC

• 1 other identifier: KY-2024-9-140-2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Elderly Patients; newly diagnosed; Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

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

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

  1 months after study treatment

Secondary Outcomes (9)

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

  1 months after the start of study treatment

• Complete Remission (CR) Rate after 1 courses of treatment

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

• Rate of Minimal Residual Disease (MRD)-Negative Response

  after each courses of chemotherapy (each course is 28 days)

• Event-free survival

  180 days after study treatment

• Overall Survival

  180 days after study treatment

Study Arms (2)

Venetoclax Combined With CACAG Regimen

EXPERIMENTAL

The entire treatment period for the CACAG+Venetoclax regimen in the trial is 2 week, with a treatment cycle of every 4 weeks, and a total of 2 course of treatment. Chidamide: 30 mg, twice a week, for a total of 4 administrations; Azacitidine: 75 mg/m\^2 from day 1 to day 7; Cytarabine (Ara-C): 75-100 mg/m\^2 every 12 hours from day 1 to day 7; Aclarubicin: 20 mg/m\^2 on days 1, 3, and 5; Recombinant human granulocyte colony-stimulating factor (G-CSF): 300 μg/day, to be discontinued when neutrophils recover and white blood cell count is ≥20,000/μL; Venetoclax: 100 mg on day 1, 200 mg on day 2, 400 mg from day 3 to day 14, used in combination with azoles, with a reduced dosage of 100 mg/day.

Drug: Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte

the standard "3+7" regimen

ACTIVE COMPARATOR

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: the standard "3+7" regimen

Interventions

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.

the standard "3+7" regimen

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.

Venetoclax Combined With CACAG Regimen

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

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

Study Sites (1)

Chinese PLA General Hospital

Beijing, None Selected, 100853, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; Cytarabine; aclacinomycins; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Arabinonucleosides

Study Officials

• Dahong Liu, Doctor

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Dahong Liu Liu, doctor

CONTACT

+8613681171597; daihongrmg@163.com

Liping Dou, Doctor

CONTACT

+8613681207138; lipingruirui@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Hematology, The Fifth Medical Center of Chinese PLA General Hospital

Model Details: randomized, controlled clinical trial,

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: April 7, 2026
• Study Start: November 18, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-03

Locations

CN (1)