a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT07007949
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivosidenib combined with venetoclax and azacitidine — DRUG
    • 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 — DRUG
    • 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.

Study Details

This is a single arm, open-label, multicenter clinical trial to evaluate the efficacy and safety of ivosidenib+venetoclax+ azacitidine in adult Chinese subjects with newly diagnosed IDH1m AML.A total of approximately 42 China Nationwide subjects with newly diagnosed IDH1m AML will participate in the study.The primary endpoint of the study is the complete remission(CR) + CR with partial hematologic recovery(CRh) rate, and the key secondary endpoints are CR rate,event-free survival (EFS),overall survival (OS),the objective response rate (ORR).

Key Dates

Start date
Jun 1, 2025
Status verified
May 2025
Primary completion
Apr 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Unfit Arm
    Unfit subjects should be treated for a minimum of 6 cycles of combination therapy unless they experience relapse after achieving a CR, CRi (including CRp), or morphologic leukemia-free state (MLFS); disease progression after having previously attained partial remission (PR) or stable disease; unacceptable toxicity (adverse event \[AE\]); confirmed pregnancy; withdrawal by subject; protocol violation; death; end of Study or other Protocol-specified event endpoints (refer to study design).
  • Experimental: Fit Arm
    Fit subjects should be treated for a minimum of 2 cycles of combination therapy unless they experience relapse after achieving a CR, CRi (including CRp), or morphologic leukemia-free state (MLFS); disease progression after having previously attained partial remission (PR) or stable disease; unacceptable toxicity (adverse event \[AE\]); confirmed pregnancy; withdrawal by subject; protocol violation; death; end of Study or other Protocol-specified event endpoints (refer to study design).

Primary Outcome Measure

CR + CRh rate [ Time Frame: 1 year ]

Central Contacts

Related Studies