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

NCT ID: NCT06451861

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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%.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myeloid Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ABC-14 regimen

AZA,Venetoclax,Chidamide

Group Type EXPERIMENTAL

Chidamide

Intervention Type DRUG

Induction Therapy

Venetoclax

Intervention Type DRUG

Induction Therapy

azacitidine

Intervention Type DRUG

Induction Therapy

3+7 chemotherapy regimen

Daunorubicin/idarubicin/mitoxantrone and cytarabine

Group Type ACTIVE_COMPARATOR

Anthracyclines or anthraquinones

Intervention Type DRUG

Induction Therapy

cytarabine

Intervention Type DRUG

Induction Therapy

AB-14 regimen

AZA,Venetoclax

Group Type ACTIVE_COMPARATOR

Venetoclax

Intervention Type DRUG

Induction Therapy

azacitidine

Intervention Type DRUG

Induction Therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chidamide

Induction Therapy

Intervention Type DRUG

Venetoclax

Induction Therapy

Intervention Type DRUG

azacitidine

Induction Therapy

Intervention Type DRUG

Anthracyclines or anthraquinones

Induction Therapy

Intervention Type DRUG

cytarabine

Induction Therapy

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

idarubicin daunorubicin mitoxantrone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jianyu Weng

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People Hosptial

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dongguan General Hosptial

Dongguan, Guangdong, China

Site Status RECRUITING

Foshan First People's Hospital

Foshan, Guangdong, China

Site Status RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Site Status RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Shenzhen second people's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Site Status RECRUITING

Zhuhai General Hosptial

Zhuhai, Guangdong, China

Site Status RECRUITING

Hainan General Hosptial

Haikou, Hainan, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jianyu Weng

Role: CONTACT

020-83827812

Du Xin

Role: CONTACT

020-83827812

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

yirong Jiang

Role: primary

Ying Zhao

Role: primary

Xin Du

Role: primary

Jianyu WENG

Role: backup

yang Liang

Role: primary

Runhui Zheng

Role: primary

xueyi Pan

Role: primary

Zhenqian Huang

Role: primary

Liye Zhong

Role: primary

xu Ye

Role: primary

xin Du

Role: primary

Yuming ZHANG

Role: primary

xiaoliang Li

Role: primary

Li'e Lin

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ABC-14_101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MRD-positive AML Clinical Study
NCT07131059 RECRUITING NA