Study of SA+X in the Treatment of Newly Diagnosed AML
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Nowo zdiagnozowana ostra białaczka szpikowa potwierdzona badaniem szpiku
- •Wiek co najmniej 18 lat
- •Ogólny stan zdrowia pozwalający na leczenie (ECOG 0-3)
- •Liczba białych krwinek poniżej 25 × 10⁹/L na początek leczenia
- •Prawidłowe funkcjonowanie wątroby, nerek i innych ważnych organów
- •Pisemna zgoda pacjenta lub przedstawiciela prawnego na udział w badaniu
✗ Disqualifies
- •Białaczka szpikowa typu APL (M3) - inny podtyp wymagający innego leczenia
- •Białaczka wznowiona lub oporna na poprzednie leczenie
- •Historia przewlekłej białaczki szpikowej lub innych chorób szpiku
- •Białaczka rozprzestrzenienia się do mózgu
- •Alergia na któregokolwiek z leków badania
- •Problemy z przełykaniem tabletek lub zaburzenia wchłaniania
- •Poważne problemy z sercem (zaburzenia rytmu, zawał w przeszłości)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 21, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
Shanghai, China
Trial contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/22/2026.
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