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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06841952 on ClinicalTrials.gov