AML patients with NPM1 or IDH1/IDH2 mutations who are eligible for intensive chemotherapy
Conditions
Interventions
Control group:Doxorubicin+Cytarabine
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute myeloid leukemia (non-APL) diagnosed according to the 2022 ELN classification system; 2. NPM1 mutation (type A, B, D or rare) and/or IDH1/IDH2 mutation at initial diagnosis; 3. No previous induction therapy (except hydroxyurea); 4. ECOG PS score 0-3; 5. Adequate organ function, defined as follows: (1) liver function: serum total bilirubin =30ml/min; (3) Cardiac function: New York Heart Association (NYHA) grade <=2; 6. Subjects must be able to understand and willing to participate in this study, and sign an informed consent form
Exclusion criteria
Exclusion criteria: 1.Acute promyelocytic leukemia; 2.Merge extramedullary infiltration such as central nervous system leukemia; 3.Have a clear history of CMML or MDS, and later progress to AML; Or have a history of malignant tumors; 4.There is uncontrolled active infection (including bacterial, fungal, or viral infections); 5.Pregnant or lactating women; 6.Researchers determine that participants are not suitable to participate in this experiment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Complete Remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of grade 3-4 adverse events;1-year event free survival rate;Incidence of severe infection(Grade 3-4);Duration of severe myelosuppression;1-year recurrence-free survival rate;Complete Remission;Minimal Residual Disease (MRD) Negativity Rate;Treatment-related mortality; | — |
Countries
China
Contacts
Public ContactYang Shen
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed