42
Participants
Start Date
June 1, 2025
Primary Completion Date
April 30, 2026
Study Completion Date
December 31, 2026
Ivosidenib combined with venetoclax and azacitidine
• Ivosidenib (Ivo): The dosage is 500 mg, administered orally once daily (QD). Oral administration begins on Day 15 of Cycle 1 (C1D15) and continues on each subsequent day of the following cycles. Each cycle lasts 28 days (±2 days), with continuous dosing. • Venetoclax (Ven): The dosage is 100 mg on Day 1 of Cycle 1 (C1D1), 200 mg on Day 2 of Cycle 1 (C1D2), and 400 mg on Days 3-14 of Cycle 1 (C1D3-14), administered orally once daily (QD). For subsequent cycles, the dosage is 400 mg on Days 1-14, administered orally once daily (QD). • Azacitidine (Aza): The dosage is 75 mg/m² per day, administered via subcutaneous injection (Subcutaneous injection, SC) or intravenous injection (Intravenous, IV). It is given during the first week (7 days) of each 4-week (28-day) cycle (or according to the 5-2-2 dosing schedule). Whenever possible, each subject should use the same dosing schedule throughout the treatment period.
Ivosidenib combined with venetoclax and azacitidine
• Ivosidenib (Ivo): The dosage is 500 mg, administered orally once daily (QD). Oral administration begins on Day 15 of Cycle 1 (C1D15) and continues on each subsequent day of the following cycles. Each cycle lasts 28 days (±2 days), with continuous dosing. • Venetoclax (Ven): The dosage is 100 mg on Day 1 of Cycle 1 (C1D1), 200 mg on Day 2 of Cycle 1 (C1D2), and 400 mg on Days 3-14 of Cycle 1 (C1D3-14), administered orally once daily (QD). For subsequent cycles, the dosage is 400 mg on Days 1-14, administered orally once daily (QD). • Azacitidine (Aza): The dosage is 75 mg/m² per day, administered via subcutaneous injection (Subcutaneous injection, SC) or intravenous injection (Intravenous, IV). It is given during the first week (7 days) of each 4-week (28-day) cycle (or according to the 5-2-2 dosing schedule). Whenever possible, each subject should use the same dosing schedule throughout the treatment period.
RECRUITING
The First Affiliated Hospital of Soochow University, Suzhou
The First Affiliated Hospital of Soochow University
OTHER