drugset / Trial / NCT06841952
Study of Tretinoin Capsules in Combination With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia
RandomizedParallel-groupOpen-labelOther
Summary
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.
Timeline
- Start
- 2025-02-15
- Primary completion
- 2028-12-15
- Completion
- 2030-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Comparator | Cytarabine | Small molecule | 100 mg/m2 | — |
| Comparator | Cytarabine | Small molecule | 1500 mg/m2 | — |
| Comparator | Cytarabine | Small molecule | 2000 mg/m2 | — |
| Comparator | Daunorubicin | Small molecule | 60 mg/m2 | — |
| Subject | Tretinoin | Small molecule | 45 mg/m2 | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |