Study of Tretinoin Capsules in Combination With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia
NCT06841952 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158
Last updated 2025-02-24
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.
Conditions
- AML, Adult
Interventions
- DRUG
-
ATRA+Venetoclax+Azacitidine
Participants will receive a standard dose of azacitidine (75mg/m²/day),venetoclax (target dose, 400 mg),ATRA 45mg/m²/day
- DRUG
-
Chemotherapy drug
Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin).
Sponsors & Collaborators
-
The First Affiliated Hospital of Soochow University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-15
- Primary Completion
- 2028-12-15
- Completion
- 2030-12-15
Countries
- China
Study Locations
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