Phase 2 AML Trial, Sonrotoclax + Azacitidine, Apr 2026
ClinicalTrials.gov Studies
Summary
A Phase II open-label clinical trial (NCT07548710) evaluating sonrotoclax (SA) in combination with azacitidine (AZA) plus individualized targeted or chemotherapeutic agents for adult participants with newly diagnosed acute myeloid leukemia (AML). Participants are stratified by genetic background (FLT3/IDH1 mutation status) and fitness for intensive chemotherapy. The trial involves dose escalation of sonrotoclax from 20 mg/day to 320 mg/day, combined with azacitidine 75 mg/m²/day intravenously on Days 1–7 of each 28-day cycle, with additional agents including gilteritinib for FLT3 mutations or ivosidenib for IDH1 mutations. Enrolled participants will be followed for efficacy and safety outcomes.
“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).”
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What changed
The trial broadens the therapeutic landscape for newly diagnosed AML by evaluating sonrotoclax, an investigational agent, in combination with standard azacitidine and additional targeted therapies selected based on participants' genetic profiles (FLT3/IDH1 mutations). For healthcare providers and trial sponsors, this registration signals an active Phase II enrollment effort for a novel BCL-2 inhibitor combination regimen. The multi-arm stratification design reflects the trend toward genetically guided AML treatment and may generate comparative evidence on incremental benefit of adding targeted agents to hypomethylating-agent-based therapy.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Study of SA+X in the Treatment of Newly Diagnosed AML
Phase 2 NCT07548710 Kind: PHASE2 Apr 23, 2026
Abstract
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.
Conditions: Acute Myeloid Leukemia
Interventions: Anthracycline, Ivosidenib, Gilteritinib, Sonrotoclax, Azacitidine (AZA)
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