Clinical trial · Interventional
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
NCT06451861CI-TRIAL-00097259recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anthracyclines or anthraquinones | Drug | — | UNRESOLVED |
| azacitidine | Drug | Azacitidine | ALIAS |
| Chidamide | Drug | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ABC-14 regimen
- description
- AZA,Venetoclax,Chidamide
- interventionNames
- Drug: Chidamide
- Drug: Venetoclax
- Drug: azacitidine
- type
- ACTIVE_COMPARATOR
- label
- 3+7 chemotherapy regimen
- description
- Daunorubicin/idarubicin/mitoxantrone and cytarabine
- interventionNames
- Drug: Anthracyclines or anthraquinones
- Drug: cytarabine
- type
- ACTIVE_COMPARATOR
- label
- AB-14 regimen
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDYan 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):38. doi: 10.1186/s13063-025-09339-y. PMID 41366419