Actively Recruiting
Study of SA+X in the Treatment of Newly Diagnosed AML
Led by Ruijin Hospital · Updated on 2026-04-23
205
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of SA+X in the Treatment of Newly Diagnosed AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed AML confirmed by bone marrow morphology and immunophenotyping according to WHO criteria
- Exclusion of acute promyelocytic leukemia (APL) by fusion gene and chromosome tests
- ECOG performance status between 0 and 3
- Age 18 years or older
- White blood cell count less than 25 x 10⁹/L at treatment start
- Adequate organ function: AST and ALT less than or equal to 3 times upper limit of normal unless due to leukemia; total bilirubin less than 3 times upper limit of normal with exceptions; serum creatinine less than 3 times upper limit or creatinine clearance at least 30 mL/min
- Written informed consent provided by participant or legal representative
You will not qualify if you...
- FAB classification M3 or molecularly confirmed APL
- Refractory or relapsed AML
- History of myeloproliferative neoplasms, myelodysplastic syndromes, or chronic myeloid leukemia
- Mixed phenotype acute leukemia
- Central nervous system or extramedullary leukemia except liver, spleen, and lymph node involvement
- Allergy or hypersensitivity to any study drugs
- Conditions impairing swallowing or gastrointestinal absorption
- Cardiac issues including long QT syndrome, significant arrhythmias, recent myocardial infarction, or pericardial disease
- Other active or recent malignancies except certain controlled skin or in situ cancers
- Significantly abnormal liver or kidney function unrelated to AML
- Prior anti-AML treatments other than hydroxyurea
- Unrelated coagulopathy
- HIV, syphilis, hepatitis C, or active hepatitis B infection
- Other uncontrolled infections
- Pregnant or breastfeeding
- Inability to comply with study protocol
- Participation in other clinical studies within 30 days
- Investigator judgment deeming participation inappropriate
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
Y
Yang Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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