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

NCT06451861 | Recruiting Phase 2

• 1 other identifier: ABC-14_101
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 13

Brief 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

Conditions

Acute Myeloid Leukemia

Keywords

ABC-14 regimen; "3+7" regimen; AB-14 regimen

Outcome Measures

Primary Outcomes (1)

• Composite complete remission (CRc)

  composite complete remission，CRc: CR + CRi + MLFS

  2 months

Secondary Outcomes (5)

• the rate of MRD turn negative

  6 months

• DoR

  2 year

• RFS

  1 year

• OS

  1 year

• AE

  Throughout the study until the end, up to 2 years

Study Arms (3)

ABC-14 regimen

EXPERIMENTAL

AZA,Venetoclax,Chidamide

Drug: Chidamide; Drug: Venetoclax; Drug: azacitidine

3+7 chemotherapy regimen

ACTIVE COMPARATOR

Daunorubicin/idarubicin/mitoxantrone and cytarabine

Drug: Anthracyclines or anthraquinones; Drug: cytarabine

AB-14 regimen

ACTIVE COMPARATOR

AZA,Venetoclax

Drug: Venetoclax; Drug: azacitidine

Interventions

Chidamide DRUG

Induction Therapy

ABC-14 regimen

Venetoclax DRUG

Induction Therapy

AB-14 regimen; ABC-14 regimen

azacitidine DRUG

Induction Therapy

AB-14 regimen; ABC-14 regimen

Anthracyclines or anthraquinones DRUG

Induction Therapy

Also known as: idarubicin, daunorubicin, mitoxantrone

3+7 chemotherapy regimen

cytarabine DRUG

Induction Therapy

3+7 chemotherapy regimen

Eligibility Criteria

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

You may qualify if:

• 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);
• Age ≥18 years old;
• ECOG≤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.

You may not qualify if:

• Known history of allergy to the investigational drug;
• Resistance to azacytidine, azacitidine, Venetoclax;
• Inability to take oral medication;
• Combined with uncontrolled active infections (including bacterial, fungal or viral infections);
• Combined with uncontrolled major organ dysfunction: cardiac insufficiency, decompensated liver insufficiency, moderate/severe renal insufficiency, etc.;
• Participating in other clinical studies that affect the main purpose of this study; Patients deemed unsuitable for participation in this study.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (13)

Dongguan General Hosptial

Dongguan, Guangdong, China

RECRUITING

Foshan First People's Hospital

Foshan, Guangdong, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Shenzhen second people's Hospital

Shenzhen, Guangdong, China

RECRUITING

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

RECRUITING

Zhuhai General Hosptial

Zhuhai, Guangdong, China

RECRUITING

Hainan General Hosptial

Haikou, Hainan, China

RECRUITING

Related Publications (1)

• Yan H, Huang X, Wu P, Deng C, Li M, Lai P, Du X, Weng J. Comparing the efficacy and safety of the ABC-14 regimen (azacitidine, venetoclax, and chidamide) with traditional "3 + 7" intensive induction regimen or AB-14 regimen (venetoclax combined with azacitidine) in newly diagnosed AML: study protocol for a prospective, multicenter, randomized, open-label clinical trial. Trials. 2025 Dec 10. doi: 10.1186/s13063-025-09339-y. Online ahead of print.

  PMID: 41366419 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; venetoclax; Azacitidine; Anthracyclines; Anthraquinones; Idarubicin; Daunorubicin; Mitoxantrone; Cytarabine

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; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Anthrones; Anthracenes; Quinones; Arabinonucleosides

Study Officials

• Jianyu Weng

  Guangdong Provincial People Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianyu Weng

CONTACT

020-83827812; wengjianyu@gdph.org.cn

Du Xin

CONTACT

020-83827812; xind@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: June 11, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)