About this trial
This study was a prospective, two-arm, multicenter clinical trial to evaluate the efficacy and safety of tretinoin capsules combined with azacitidine and venetoclax in the treatment of newly diagnosed acute myeloid leukemia. Azacitidine, venetoclax, and tretinoin may arrest cancer cell growth by demethylation, promoting cell differentiation, or killing cells, while reducing blood-related adverse effects by promoting cell differentiation.
Eligibility criteria
Qualifiers
Patients initially diagnosed with AML (excluding APL) according to WHO diagnostic criteria.
Patients who have not previously received other induction therapies (excluding hydroxyurea and leukapheresis).
Total white blood cell (WBC) count ≤ 25 × 10^9/L.
Ages 18 to 60 years, inclusive, with no gender restrictions.
Disqualifiers
Patients with Acute Promyelocytic Leukemia (APL).
Patients with concomitant central nervous system leukemia or extramedullary leukemia involvement, such as testicular infiltration.
Patients with current or historical immunodeficiency virus infection.
Patients with active Hepatitis B or Hepatitis C infection.
Trial design
Treatments tested in this trial
- ATRA+Venetoclax+Azacitidine
- Chemotherapy drug