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COMPLETED
NCT06073730
PHASE3

Comparison of the Efficacy and Safety of Venetoclax in Combination With 3 Days Decitabine (DEC3-VEN) vs. Venetoclax in Combination With Azacitidine (VIALE-A) in the Treatment of Elderly Patients or Unfit, New-diagnosis Acute Myeloid Leukemia Patients

Sponsor: The Second Affiliated Hospital of Kunming Medical University

View on ClinicalTrials.gov

Summary

Combining the results of previous studies and based on the clinical practice in our center, we designed the Venetoclax in combination with 3days-Decitabine regimen for induction therapy in elderly or unfit AML patients with a primary diagnosis, and set Venetoclax in combination with Azacitidine (VIALE-A) as a control group to compare the efficacy and safety and to provide evidence for the optimal selection of the clinical treatment regimen. PRIMARY ENDPOINT: To assess whether Venetoclax in combination with 3 days-diascitabine versus standard dose Venetoclax in combination with azacitidine improves event-free survival (EFS) in elderly or adult patients with unfit AML during the maximum follow-up period. Event-free survival was defined as the absence of events such as treatment failure, intolerance withdrawal, all-cause death, or achievement of CR or CRi, or relapse after MLFS, whichever occurred first, between patients' randomization and the maximum follow-up period. Treatment failure was defined as failure to achieve CR or CRi, MLFS after 2 courses of induction therapy.

Official title: Department of Hematology, The Second Affiliated Hospital of Kunming Medical University.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

154

Start Date

2023-11-01

Completion Date

2026-04-30

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

PROCEDURE

Experimental: Venetoclax in combination with Decitabine (+-sorafenib)

Venetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-14 Decitabine (DEC) 20mg/m2/q8h, d4-6 (infusion time \>2h) Sorafenib 600mg/d, d8-14 (FLT3/ITD mutation positive patients)

PROCEDURE

Active Comparator: Standard dose of Venetoclax + Azacitidine

Venetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-28 Azacitidine (AZA) 75mg/m2/d, d3-9

Locations (1)

The Second Affiliated Hospital of Kunming Medical University.

Kunming, Yunnan, China