Newly diagnosed adult acute myeloid leukemia (AML, excluding APL)
Conditions
Interventions
UNFIT IDH1/FLT3mut:On the basis of the SA plan, individualized treatment with "X" medication is adopted
UNFIT IDH1/FLT3wt:SA plan: Sotocla 20mg d1, 40mg d2, 80mg d3, 160mg d4, 320mg d5-21/28
Azacitidine AZA 75mg/m2, iH, d1-d7
FIT IDH1/FLT3wt:SA regimen+DNR 60mg/m2/d, d1-d3 or IDA 10mg/m2/d, d1-d3
FIT IDH1/FLT3mut:On the basis of the SA plan, individualized treatment with "X" medication is adopted
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed AML confirmed by bone marrow morphology and immunophenotyping (5th edition WHO diagnostic criteria); 2. Subjects with APL excluded according to fusion gene and chromosome results; 3. ECOG performance status 0–3; 4. Age >= 18 years; 5. White blood cell count must be = 30 mL/min by Cockcroft-Gault formula; 7. Written informed consent obtained from the subject or legal representative;
Exclusion criteria
Exclusion criteria: 1. FAB classification as M3, or molecularly confirmed APL; 2. Refractory / relapsed subjects; 3. Subjects with a history of myeloproliferative neoplasms (MPN); 4. Subjects with a history of myelodysplastic syndromes (MDS); 5. Subjects with a history of chronic myeloid leukemia (CML); 6. Subjects with mixed phenotype acute leukemia (MPAL); 7. Documented central nervous system leukemia; or documented extramedullary leukemia (e.g., myeloid sarcoma, skin infiltration), excluding liver, spleen, and lymph node involvement; 8. Hypersensitivity or allergy to any of the study drugs; 9. Physical conditions or organ system dysfunction that impairs the ability to swallow capsules or tablets, or significantly affects gastrointestinal function and/or absorption (including malabsorption syndrome, small bowel resection, or uncontrolled inflammatory bowel disease); 10. Cardiac conditions meeting any of the following:a) Long QT syndrome or QTc interval > 480 ms;b) Second- or third-degree atrioventricular block; severe, uncontrolled arrhythmia requiring medical treatment;c) History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other treatable arrhythmia, clinically significant pericardial disease within 6 months prior to enrollment; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; 11. Previous or current concurrent malignancy other than adequately controlled non-melanoma skin basal cell carcinoma, in situ breast/cervical carcinoma, or other malignancies adequately controlled without treatment for more than 6 months; 12. Significantly abnormal liver or renal function (serum bilirubin, AST, ALT, or serum creatinine > 3 × upper limit of normal; excluding those deemed by the investigator to be related to AML); 13. Subjects who have received previous anti-AML therapies other than hydroxyurea and cytarabine for cytoreduction, including but not limited to BCL-2, FLT3, IDH1 inhibitors, or other investigational agents; 14. Coagulopathy unrelated to AML; 15. HIV infection, syphilis infection, HCV infection, or active HBV infection (HBsAg positive; or HBsAg negative / HBcAb positive with HBV DNA > 1.0 × ULN); 16. Other uncontrolled active infection (as judged by the investigator); 17. Pregnant or breastfeeding women; 18. Unable to understand or comply with the study protocol; 19. Participation in other relevant clinical studies within 30 days (excluding diagnostic studies); 20. Subjects deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Complete Remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Minimal Residual Disease (MRD) Negativity Rate;Overall Response Rate;Overall Survival;Event-free Survival;Adverse Event;Time to neutrophil and platelet recovery; | — |
Countries
China
Contacts
Public ContactShen Yang
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed