Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 14 to 75

Comparing two treatment regimens for newly diagnosed acute myeloid leukemia

Official title: A Multicenter, Prospective, Randomized Controlled Study of the Standard "3+7" Regimen Versus Venetoclax Combined With CACAG Regimen in Newly Diagnosed Adult Patients With Intermediate- and High-risk Acute Myeloid Leukemia

Run by Chinese PLA General Hospital · NCT06928376 · Data updated 2026-11-12

This study is testing a new treatment for people with newly diagnosed acute myeloid leukemia to see if it works better than the standard treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Ages14 Years to 75 Years
SexAll
Enrollment160 (estimated)
SponsorChinese PLA General Hospital
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedApril 18, 2024
Main results expectedSeptember 1, 2025
Study endsSeptember 1, 2026
Registry record updatedMay 8, 2026
Trial IDNCT06928376 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals aged 14 to 75 who have been newly diagnosed with intermediate- or high-risk acute myeloid leukemia.

Probably not a fit

Patients with contraindications to the study drugs, severe organ dysfunction, or those who are pregnant or breastfeeding may not benefit from this study.

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

What this trial studies

This study aims to evaluate the efficacy and safety of a new treatment regimen combining venetoclax with CACAG against the traditional '3+7' regimen for patients with newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML). The trial will involve multiple centers and will assess how well these treatments work in improving patient outcomes. Participants will be closely monitored for their response to treatment and any potential side effects. The goal is to identify a more effective therapy for this challenging condition.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with acute myeloid leukemia, potentially improving survival rates.

How similar studies have gone: Other studies have shown promise in using novel combinations of therapies for AML, but this specific combination is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Age 14 to 75 years (no gender limitation) Newly diagnosed with intermediate- or high-risk AML (excluding M3) Liver function: ALT and AST ≤ 2.5 times upper limit of normal; bilirubin ≤ 2 times upper limit of normal Renal function: creatinine ≤ upper limit of normal No uncontrolled infections, organ dysfunction, or severe mental illness ECOG performance status score of 0-2 and predicted survival ≥ 4 months No severe allergic constitution

Exclusion Criteria:

Allergy or contraindication to the study drug Pregnant or breastfeeding female patients Known history of alcohol or drug addiction (due to potential non-compliance) Mental illness or conditions preventing protocol compliance Less than 6 weeks after major organ surgery Liver function: ALT and AST \> 2.5 times upper limit of normal; bilirubin \> 2 times upper limit of normal Renal function: creatinine \> upper limit of normal Deemed unsuitable for the clinical trial (poor compliance, substance abuse, etc.)

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Where it's running

  • Chinese PLA General Hospital
    Beijing, Beijing Municipality, China
    Recruiting

Similar studies

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.