Actively Recruiting
A Multicenter, Randomized Study Comparing Standard "3+7" Chemotherapy Versus Venetoclax Combined with CACAG Regimen in Adults with Intermediate- and High-risk Acute Myeloid Leukemia
Led by Chinese PLA General Hospital · Updated on 2026-05-08
160
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Chinese PLA General Hospital
Lead Sponsor
F
First Affiliated Hospital of Harbin Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new treatment approach combining venetoclax with the CACAG regimen compared to the traditional "3+7" chemotherapy regimen for adults newly diagnosed with intermediate- or high-risk acute myeloid leukemia (AML). Despite advances like stem cell transplantation and new drugs, AML prognosis remains poor, making this comparison important. The study includes two treatment groups. One group receives the combined venetoclax and CACAG regimen, which involves a 1-week treatment cycle repeated every 4 weeks and includes drugs such as chidamide, azacitidine, cytarabine, aclarubicin, granulocyte colony-stimulating factor (G-CSF), and venetoclax with specific dosing schedules. The other group receives the standard "3+7" regimen, consisting of idarubicin or daunorubicin plus cytarabine over several days. Each participant undergoes one full course of treatment. Participants will be monitored through various assessments including blood tests, response evaluations, and survival tracking at set intervals. The main outcome measured is the composite complete remission rate one month after treatment. Additional outcomes include overall response, minimal residual disease status, survival rates up to 180 days, treatment-related side effects, and early death rates. Safety and efficacy will be closely observed throughout the study duration, which runs until September 2026.
CONDITIONS
Brief Title
A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 75 years
- Newly diagnosed with intermediate- or high-risk acute myeloid leukemia (excluding M3 subtype)
- Liver function with ALT and AST less than or equal to 2.5 times the upper limit of normal
- Bilirubin less than or equal to 2 times the upper limit of normal
- Normal kidney function with creatinine at or below the upper limit of normal
- No uncontrolled infections, organ dysfunction, or severe mental illness
- ECOG performance status score of 0 to 2 with predicted survival of at least 4 months
- No severe allergic constitution
You will not qualify if you...
- Allergy or contraindication to any study drug
- Pregnant or breastfeeding females
- Known history of alcohol or drug addiction
- Mental illness or conditions preventing compliance with the study protocol
- Less than 6 weeks since major organ surgery
- Liver function with ALT and AST greater than 2.5 times the upper limit of normal
- Bilirubin greater than 2 times the upper limit of normal
- Kidney function with creatinine above the upper limit of normal
- Deemed unsuitable for the clinical trial due to poor compliance or substance abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 course lasting approximately 1 week with treatment cycles every 4 weeks
Participants receive either the experimental Venetoclax combined with CACAG regimen or the standard "3+7" chemotherapy regimen as induction treatment for acute myeloid leukemia.
Multiple visits during 1 treatment course over 1 week
Duration - Up to 6 months after treatment
Participants are monitored for treatment response and safety after completing the treatment course.
Visits for assessments up to 180 days after treatment
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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