Clinical trial · Interventional
Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia
Venetoclax-Azacitidine in Combination With Chidamide and CAG Versus 3+7 Regimen in Fit Older Patients With Acute Myeloid Leukaemia:A Multicenter, Randomized, Controlled, Phase 3 Trial
- 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)
This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard "3+7" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Elderly Patients | — | UNRESOLVED | — |
| Newly Diagnosed Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte | Drug | — | UNRESOLVED |
| the standard "3+7" regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Venetoclax Combined With CACAG Regimen
- description
- The entire treatment period for the CACAG+Venetoclax regimen in the trial is 2 week, with a treatment cycle of every 4 weeks, and a total of 2 course of treatment. Chidamide: 30 mg, twice a week, for a total of 4 administrations; Azacitidine: 75 mg/m\^2 from day 1 to day 7; Cytarabine (Ara-C): 75-100 mg/m\^2 every 12 hours from day 1 to day 7; Aclarubicin: 20 mg/m\^2 on days 1, 3, and 5; Recombinant human granulocyte colony-stimulating factor (G-CSF): 300 μg/day, to be discontinued when neutrophils recover and white blood cell count is ≥20,000/μL; Venetoclax: 100 mg on day 1, 200 mg on day 2, 400 mg from day 3 to day 14, used in combination with azoles, with a reduced dosage of 100 mg/day.
- interventionNames
- Drug: Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte
- type
- ACTIVE_COMPARATOR
- label
- the standard "3+7" regimen
- description
- IA Regimen: Idarubicin: 8-12 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7. Or DA Regimen: Daunorubicin: 60 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7. Or MA Regimen: Mitoxantrone: 6-10 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntary participation in the clinical study; the subject or legal guardian fully understands and is informed about the study and has signed the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures; 2. Age between 60-75 years at the time of screening, with no gender restrictions; 3. Patients are newly diagnosed with AML, and the diagnosis conforms to the standards of the Chinese Medical Association 2021 edition; 4. No severe allergic constitution; 5. Liver function: ALT and AST \<= 2.5 times the upper limit of normal values, bilirubin \<= 2 times the upper limit of normal values; 6. Renal function: creatinine \<= upper limit of normal values; 7. No uncontrollable infections or severe mental illnesses; 8. Performance status score is 0-3 (ECOG), with an expected survival of at least 4 months. Exclusion Criteria: 1. Patients who are allergic to the study medication or have contraindications to it; 2. Pregnant or breastfeeding women; 3. Patients with active infections; 4. Patients with long-term smoking or alcohol abuse that could affect the evaluation of trial results; 5. Patients with mental disorders or other conditions that prevent obtaining informed consent, or who are unable to cooperate with the treatment and examination procedures; 6. Patients who have undergone major organ surgery within the last 6 weeks; 7. Abnormal liver function, with total bilirubin \> 1.5 times the upper limit of normal, ALT/AST \> 2.5 times the upper limit of normal, or liver-infiltrated patients with ALT/AST \> 5 times the upper limit of normal; abnormal renal function, with serum creatinine \> 1.5 times the upper limit of normal; 8. Patients whom the investigator deems unsuitable for this clinical trial (e.g., poor compliance, drug abuse, etc.).
References
Publications (0)
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