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

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.

NCT Number	NCT07548710
Lead Sponsor	Ruijin Hospital Collaborators: Shanghai Fengxian District Central Hospital, Chinese People's Liberation Army No 455 Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Tong Ren Hospital, Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, Shanghai Jiahui International Hospital, The First Hospital of Jilin University, Huadong Hospital, The First People's Hospital of Yunnan, Shanghai 7th People's Hospital
Conditions	Acute Myeloid Leukemia
Enrollment	205 participants
Start Date	2026-05-01
Primary Completion	2027-05-31 (estimated)
Study Completion	2028-12-21 (estimated)
Updated on ClinicalTrials.gov	2026-07-30