Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML

Last updated: November 14, 2025
Sponsor: Guangdong Provincial People's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Leukemia

Platelet Disorders

Acute Myeloid Leukemia

Treatment

Venetoclax

Anthracyclines or anthraquinones

cytarabine

Clinical Study ID

NCT06451861
ABC-14_101
  • Ages > 18
  • All Genders

Study Summary

To compare the efficacy and safty of ABC-14 regimen with the traditional "3+7" regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed with AML (the diagnostic criteria refer to WHO2022 standard, non-APL), andhave not received systemic anti-leukemia therapy (except hydroxyurea, low-dosecytarabine and other tumor reduction pretreatments);

  2. Age ≥18 years old;

  3. ECOG≤4;

  4. The fertile woman agrees to use effective contraception during the treatment periodand up to 3 months after the end of the treatment; Sign the informed consent form.

Exclusion

Exclusion Criteria:

  1. Known history of allergy to the investigational drug;

  2. Resistance to azacytidine, azacitidine, Venetoclax;

  3. Inability to take oral medication;

  4. Combined with uncontrolled active infections (including bacterial, fungal or viralinfections);

  5. Combined with uncontrolled major organ dysfunction: cardiac insufficiency,decompensated liver insufficiency, moderate/severe renal insufficiency, etc.;

  6. Participating in other clinical studies that affect the main purpose of this study;Patients deemed unsuitable for participation in this study.

Study Design

Total Participants: 240
Treatment Group(s): 5
Primary Treatment: Venetoclax
Phase: 2
Study Start date:
August 21, 2024
Estimated Completion Date:
June 30, 2027

Study Description

Acute myeloid leukemia (AML) is a clonal malignant blood disease with genetic heterogeneity and originated from hematopoietic stem progenitor cells.In the past 50 years, the "3+7" induction regimen represented by cytotoxic drugs (including anthracyclines/anthraquinones combined with cytarabine) has remained the standard induction regimen for newly diagnosed AML patients with intensive chemotherapy. In AML patients <60 years old, the "3+7" regimen induces a complete response rate of 60% to 80%, but the treatment-related mortality is as high as 13%, and more than half of the patients face the threat of relapse, and the 5-year overall survival rate is about 35% to 40%.

Connect with a study center

  • Dongguan General Hosptial

    Dongguan, Guangdong
    China

    Site Not Available

  • Foshan First People's Hospital

    Foshan, Guangdong
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong
    China

    Site Not Available

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Shenzhen second people's Hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong
    China

    Site Not Available

  • Zhuhai General Hosptial

    Zhuhai, Guangdong
    China

    Site Not Available

  • Dongguan General Hosptial

    Dongguan 1812545, Guangdong 1809935
    China

    Active - Recruiting

  • Foshan First People's Hospital

    Foshan 1811103, Guangdong 1809935
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou 1809858, Guangdong 1809935 510080
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou 1809858, Guangdong 1809935
    China

    Active - Recruiting

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou 1809858, Guangdong 1809935
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou 1809858, Guangdong 1809935
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou 1809858, Guangdong 1809935
    China

    Active - Recruiting

  • The First Affiliated Hospital of Jinan University

    Guangzhou 1809858, Guangdong 1809935
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou 1809858, Guangdong 1809935
    China

    Active - Recruiting

  • Shenzhen second people's Hospital

    Shenzhen 1795565, Guangdong 1809935
    China

    Active - Recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang 1784990, Guangdong 1809935
    China

    Active - Recruiting

  • Zhuhai General Hosptial

    Zhuhai 1790437, Guangdong 1809935
    China

    Active - Recruiting

  • Hainan General Hosptial

    Haikou, Hainan
    China

    Site Not Available

  • Hainan General Hosptial

    Haikou 1809078, Hainan 1809054
    China

    Active - Recruiting

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