Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chidamide, Venetoclax, azacitidine, Anthracyclines or anthraquinones.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
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%.
Interventions
- Drug Chidamide
Induction Therapy - Drug Venetoclax
Induction Therapy - Drug azacitidine
Induction Therapy - Drug Anthracyclines or anthraquinones
Induction Therapy - Drug cytarabine
Induction Therapy
Primary outcome measures
- Composite complete remission (CRc) [Time frame: 2 months]
Secondary outcome measures (5)
- the rate of MRD turn negative [Time frame: 6 months]
- DoR [Time frame: 2 year]
- RFS [Time frame: 1 year]
- OS [Time frame: 1 year]
- AE [Time frame: Throughout the study until the end, up to 2 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 13 centers
- Dongguan General Hosptial — Dongguan
- Foshan First People's Hospital — Foshan
- Guangdong Provincial People's Hospital — Guangzhou
- Sun Yat-sen University Cancer Center — Guangzhou
- The Fifth Affiliated Hospital of Guangzhou Medical University — Guangzhou
- The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
- The First Affiliated Hospital of Jinan University — Guangzhou
- … and 5 more centers
Publications
- 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;27(1):3 PMID 41366419
Identifiers
NCT: NCT06451861 · ABC-14_101