NCT06073730View on ClinicalTrials.gov

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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

November 1, 2024

Study Completion Date

November 1, 2025

Conditions
Elderly AML PatientsUnfit, New-diagnosis AMLAcute Myeloid LeukemiaVenetoclaxDecitabine
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

Trial Locations (1)

Unknown

The Second Affiliated Hospital of Kunming Medical University., Kunming

All Listed Sponsors
lead

The Second Affiliated Hospital of Kunming Medical University

OTHER

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 | Biotech Hunter | Biotech Hunter