Study of SA+X in the Treatment of Newly Diagnosed AML

Sponsor
Ruijin Hospital
Study ID
NCT07548710
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Anthracycline — DRUG
    For FLT3/IDH1 wild-type participants who are eligible for chemotherapy, Anthracycline: Daunorubicin (DNR) 45 mg/m² per day on Days 1-3, or Idarubicin (IDA) 6 mg/m² per day on Days 1-3.
  • Ivosidenib — DRUG
    For IDH1 mutant participants, IDH1 inhibitor (IDH1i): Ivosidenib 500 mg once daily on Days 1-28.
  • Gilteritinib — DRUG
    For FLT3 mutant participants, FLT3 inhibitor (FLT3i): Gilteritinib 80 mg once daily on Days 1-14.
  • Sonrotoclax — DRUG
    For all the participants who are eligible for this trial, Sonrotoclax (SON): 20 mg/day on Day 1, 40 mg/day on Day 2, 80 mg/day on Day 3, 160 mg/day on Day 4, and 320 mg/day on Days 5-28 of a 28-day cycle; the administration of SON may be temporarily held by the investigator from Day 14 to Day 28 based on the participant's condition.
  • Azacitidine (AZA) — DRUG
    For all the participants who are eligible for this trial, Azacitidine (AZA): 75 mg/m² per day on Days 1-7.

Study Details

This is a phase II, open-label, multi-center study evaluating the efficacy and safety of sonrotoclax (SA) in combination with azacitidine (AZA) plus individualized targeted or chemotherapeutic agents in adult participants with newly diagnosed acute myeloid leukemia (AML). Eligible participants will be stratified into different treatment arms based on genetic background (FLT3/IDH1 mutation status) and fitness for intensive chemotherapy. All participants will receive sonrotoclax with dose escalation from 20 mg/day to 320 mg/day, followed by maintenance dosing, which may be temporarily held by the investigator from Day 14 to Day 28 of each 28-day cycle based on the participant's condition, combined with azacitidine 75 mg/m²/day intravenously on Days 1-7. For participants fit for intensive chemotherapy, additional anthracycline (daunorubicin 60 mg/m²/day or idarubicin 10 mg/m²/day on Days 1-3) will be administered. For participants with FLT3 mutations, gilteritinib 80 mg once daily on Days 1-14 will be added; for those with IDH1 mutations, ivosidenib 500 mg once daily on Days 1-28 will be added.

Key Dates

Start date
May 1, 2026
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
Dec 21, 2028

Study Design

Enrollment
205 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SA+Anthracycline
  • Experimental: SA+FLT3 inhibitor
  • Experimental: SA+IDH1 inhibitor
  • Experimental: SA

Primary Outcome Measure

Composite Complete Remission [ Time Frame: At the end of 2 cycles of induction therapy with the SA+X regimen (each cycle is 28 days); at the end of 4 cycles of induction therapy with the SA regimen (each cycle is 28 days). ]

Central Contacts

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