Comparing Venetoclax Plus CACAG Versus Standard 37 Chemotherapy in Adults Aged 14 to 75 With Intermediate- or High-Risk Acute Myeloid Leukemia

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 37 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 37 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.

A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients