Study of Tretinoin Capsules in Combination With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia

ConditionAML, Adult
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe First Affiliated Hospital of Soochow University

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

Treatment groups

158 Participants
are divided into 2 treatment groups