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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chinese PLA General Hospital
  Beijing, None Selected, China Recruiting

Study contacts

• Study coordinator: Dahong Liu Liu, doctor
• Email: daihongrmg@163.com
• Phone: +8613681171597

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.