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A prospective, multi-center, controlled, phase II clinical study comparing the efficacy and safety of the ABC-14 regimen (Azacitidine, Venetoclax, and Dexamethasone) with the traditional "3 + 7" regimen or the AB-14 regimen (Venetoclax combined with Azacitidine) in the treatment of newly diagnosed AML

A prospective, multi-center, controlled, phase II clinical study comparing the efficacy and safety of the ABC-14 regimen (Azacitidine, Venetoclax, and Dexamethasone) with the traditional "3 + 7" regimen or the AB-14 regimen (Venetoclax combined with Azacitidine) in the treatment of newly diagnosed AML

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108872
Enrollment
Unknown
Registered
2025-09-08
Start date
2024-08-21
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myelogenous leukemia

Interventions

ABC-14 regimen:Chidamide?Venetoclax?Azacitidine
AB-14 regimen:Azacitidine?Venetoclax
"3+7" Standard Induction Therapy:Daunorubicin or Idarubicin or mitoxantrone, cytarabine

Sponsors

Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Diagnosed with AML (diagnostic criteria refer to WHO 2022 standards, not APL), has not received systemic anti-leukemia treatment (except for tumor-reducing pretreatment such as hydroxyurea, low-dose cytarabine, etc.); 2. Age >= 18 years; 3. ECOG <= 4; 4. Women of childbearing potential agree to take effective contraceptive measures during the treatment period and for 3 months after treatment ends; 5. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Known history of allergy to the investigational drug; 2.Resistance to Azacytidine, Venetoclax or Chidamide; 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; 7.Patients deemed unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Composite complete remission;

Secondary

MeasureTime frame
Minor residual disease (MRD) negative rate;Duration of remission, DoR;1-year recurrence-free survival rate;1 year overall survival rate;

Countries

China

Contacts

Public ContactDu Xin; Weng Jianyu

Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)

wengjianyu1969@163.com+86 20 8382 7812

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026