Venetoclax Plus CACAG Regimen for Newly Diagnosed Acute Myeloid Leukemia

Last updated: July 28, 2025
Sponsor: Chinese PLA General Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Leukemia

Acute Myeloid Leukemia

Platelet Disorders

Treatment

Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor

"3+7"

Clinical Study ID

NCT06068621
S2023-056-01
  • Ages 14-75
  • All Genders

Study Summary

The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients who are able to understand and willing to sign the informed consent form (ICF).

  • All patients should aged 14 to75 years,no gender limitation.

  • Patients who are newly diagnosed with AML(no M3).

  • Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 timesthe upper limit of normal;

  • Renal function: creatinine ≤the upper limit of normal;

  • Patients without any uncontrolled infections , without organ dysfunction or withoutsevere mental illness;

  • The score of Eastern Cooperative Oncology Group (ECOG) is 0-2, and the predictedsurvival ≥ 4 months.

  • Patients without severe allergic constitution.

Exclusion

Exclusion Criteria:

  • Patients with allergy or contraindication to the study drug;

  • Female patients who are pregnant or breast-feeding.

  • Patients with a known history of alcohol or drug addiction on the basis that therecould be a higher risk of non-compliance to study treatment;

  • Patients with mental illness or other states unable to comply with the protocol;

  • Less than 6 weeks after surgical operation of important organs.

  • Liver function: ALT and AST>2.5 times the upper limit of normal ,bilirubin> 2 timesthe upper limit of normal;Renal function: creatinine >the upper limit of normal;

  • The patient is not suitable for this clinical trial (poor compliance, substanceabuse, etc.)

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
Phase: 2
Study Start date:
March 01, 2023
Estimated Completion Date:
August 31, 2025

Study Description

Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor.Over the past years, combination chemotherapy with anthracycline and standard dose cytarabine (standard "3+7" induction therapy) remains the standard induction. In order to improve the outcome of patients with de novo AML, we developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, we intent to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.

Connect with a study center

  • Chinese PLA General Hospital

    Beijing, Beijing 100853
    China

    Active - Recruiting

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