NCT06073730

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: The Second Affiliated Hospital of Kunming Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Induction therapy regimen: A: Experimental group: 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) B: Control: standard dose of Venetoclax + Azacitidine Venetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-28 Azacitidine (AZA) 75mg/m2/d, d3-9 Post-remission treatment regimen: A: Experimental group: Venetoclax combined with Decitabine Venetoclax (VEN ) 400mg/d, d1-7 Decitabine (DEC) 20mg/m2/q8h, d2-3 (this regimen is repeated every 4-6 weeks) B: Control Group: Venetoclax combined with Azacitidine Venetoclax (VEN ) 100mg d1, 200mg d2, 400mg/d d3-28 Azacitidine (AZA) 75mg/m2/d, d3-9 (this regimen is repeated every 4-6 weeks)

Conditions

• Elderly AML Patients
• Unfit, New-diagnosis AML
• Acute Myeloid Leukemia
• Venetoclax
• Decitabine

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-01
• Completion: 2025-11-01
• First posted: 2023-10-10
• Last updated: 2023-10-10

Locations

1 site across 1 country: China