Venetoclax with azacitidine, chidamide and CAG chemotherapy for fit older adults with AML

Venetoclax-Azacitidine in Combination With Chidamide and CAG Versus Daunorubicin and Cytarabine in Fit Older Patients With Acute Myeloid Leukaemia：A Multicenter, Randomized, Controlled, Phase 3 Trial

This will test whether adding venetoclax and chidamide to azacitidine plus CAG chemotherapy helps people aged 60-75 with newly diagnosed AML achieve remission more often than the standard 3+7 regimen.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 60 Years to 75 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Locations: 1 site (Beijing, None Selected)
• Trial ID: NCT07514936 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, controlled Phase 2 trial enrolls fit older adults (60-75) with newly diagnosed AML and compares a combination regimen (chidamide + azacitidine + aclarubicin + cytarabine + G-CSF + venetoclax) to the standard 3+7 chemotherapy. Participants are randomly assigned to the experimental combination or the control arm and are treated per protocol with close monitoring for remission, adverse events, and survival. The main aim is to increase remission rates while assessing safety and tolerability in this older, fit patient group. Secondary outcomes include adverse event rates, overall survival, and progression-free survival.

Who should consider this trial

Good fit: Ideal candidates are adults aged 60-75 with newly diagnosed AML who are fit enough for intensive therapy (ECOG 0-3), have acceptable liver and kidney function, and can consent to and attend treatment at a participating center.

Not a fit: Patients who are pregnant or breastfeeding, have severe uncontrolled infections, severe organ dysfunction, known allergies to the study drugs, or other contraindications are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could raise remission rates and extend survival for fit older patients while keeping side effects manageable.

How similar studies have performed: Previous trials have shown venetoclax plus azacitidine improves remission and survival in older AML patients, but adding chidamide and a CAG backbone is a newer approach with limited prior clinical data.

Eligibility criteria

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.).

Where this trial is running

Beijing, None Selected

• Chinese PLA General Hospital — Beijing, None Selected, China (Recruiting)

Study contacts

• Study coordinator: Dahong Liu Liu, doctor

Conditions Newly Diagnosed Acute Myeloid Leukemia; Elderly Patients; newly diagnosed; Acute Myeloid Leukemia