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Clinical Trial 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.


Clinical Trial 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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06073730
Study type Interventional
Source The Second Affiliated Hospital of Kunming Medical University
Contact
Status Not yet recruiting
Phase Phase 3
Start date November 1, 2023
Completion date November 1, 2025

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