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

Randomized Study of ABC-14 Regimen ( AZA, Venetoclax and Chidamide) Compared With "3+7" Standard Induction Therapy or AB-14 (Venetoclax Combined With Azacitidine) for Newly Diagnosed Acute Myeloid Leukemia

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

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Drug: Chidamide; Drug: Venetoclax; Drug: azacitidine; Drug: Anthracyclines or anthraquinones; Drug: cytarabine

Detailed 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%.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jianyu Weng; Phone Number: 020-83827812; Email: wengjianyu@gdph.org.cn
• Study Contact Backup: Name: Du Xin; Phone Number: 020-83827812; Email: xind@gdph.org.cn

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China
      • Recruiting
      • Dongguan General Hosptial
      • Contact: yirong Jiang
    • Foshan, Guangdong, China
      • Recruiting
      • Foshan First People's Hospital
      • Contact: Ying Zhao
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Yang Liang
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Zhenqian Huang
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: xin Du
      • Contact: Jianyu WENG
    • Guangzhou, Guangdong, China
      • Recruiting
      • The second Affiliated Hospital of Guangzhou Medical University
      • Contact: xu Ye
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangdong Pharmaceutical University
      • Contact: xueyi Pan
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Jinan University
      • Contact: Liye Zhong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Fifth Affiliated Hospital of Guangzhou Medical University
      • Contact: Runhui Zheng
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Second People's Hospital
      • Contact: xin Du
    • Zhanjiang, Guangdong, China
      • Recruiting
      • Affiliated Hospital of Guangdong Medical University
      • Contact: Yuming ZHANG
    • Zhuhai, Guangdong, China
      • Recruiting
      • Zhuhai General Hosptial
      • Contact: xiaoliang Li
  • Hainan
    • Haikou, Hainan, China
      • Recruiting
      • Hainan General Hosptial
      • Contact: Li'e Lin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosed with AML (the diagnostic criteria refer to WHO2022 standard, non-APL), and have not received systemic anti-leukemia therapy (except hydroxyurea, low-dose cytarabine 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 period and up to 3 months after the end of the treatment; Sign the informed consent form.

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 viral infections);
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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABC-14 regimen; AZA,Venetoclax,Chidamide	Drug: Chidamide; Induction Therapy; Drug: Venetoclax; Induction Therapy; Drug: azacitidine; Induction Therapy
Active Comparator: 3+7 chemotherapy regimen; Daunorubicin/idarubicin/mitoxantrone and cytarabine	Drug: Anthracyclines or anthraquinones; Induction Therapy; Other Names: daunorubicin; mitoxantrone; idarubicin; Drug: cytarabine; Induction Therapy
Active Comparator: AB-14 regimen; AZA,Venetoclax	Drug: Venetoclax; Induction Therapy; Drug: azacitidine; Induction Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite complete remission (CRc)	composite complete remission，CRc: CR + CRi + MLFS	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival	1 year
the rate of MRD turn negative	minimal residual disease turn negative	6 months
DoR	Duration of remission	2 year
RFS	Relapsed-free survival	1 year
AE	Incidence of of grade 3-4 adverse events/Duration of severe myelosuppression/ Incidence of severe infection/Treatment-related mortality, according to Common Terminology Criteria for Adverse Events, versions 5.0	Throughout the study until the end, up to 2 years

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: Jianyu Weng, Guangdong Provincial People Hosptial

Publications and helpful links

Helpful Links

• Blood 2023; 142 (Supplement 1): 1522. doi: https://doi.org/10.1182/blood-2023-188196

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: ABC-14 regimen; "3+7" regimen; AB-14 regimen
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Aza Compounds; Nucleosides; Ribonucleosides; Arabinonucleosides; Naphthacenes; Aminoglycosides; Anthrones; Anthracenes; Quinones; Cytarabine; Azacitidine; Daunorubicin; Mitoxantrone; Idarubicin; venetoclax; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Anthracyclines; Anthraquinones
• Other Study ID Numbers: ABC-14_101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No