Acute myeloid leukemia
Conditions
Interventions
Standard Therapy Group:Venetoclax-azacitidine standard regimen
Regimen Optimization Group:Shortened duration therapy based on day 14 bone marrow blasts
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed for the first time with AML in accordance with the WHO 2022 criteria, who have previously received azacitidine, retinoic acid and colony-stimulating factors, can be included. Before induction therapy, leukopenia can be reduced through leukapheresis, hydroxyurea or low-dose cytarabine (= 60 years; or age >= 18 years and 1.5 times the upper limit of normal; Eastern Cooperative Oncology Group (ECOG) performance status (PS) of >= 2; the investigator determines that the subject has any other comorbidities that cannot tolerate strong induction therapy; 3. Receive the induction therapy with the azacitidine combined with venetoclax regimen (intravenous azacitidine 75 mg/m2 on days 1-7 subcutaneously injected, venetoclax tablets 100 mg on day 1, 200 mg on day 2, starting at 400 mg once daily orally, if combined with potent or moderate CYP3A/P-gp inhibitors, the dose of venetoclax is adjusted according to the instructions); and have completed 12-14 days; 4. Complete the ELN2022 risk stratification assessment; 5. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of acute promyelocytic leukemia, AML with t(8;21)(q22;q22.1)/RUNX1::RUNX1T1 translocation, or blast crisis of chronic myeloid leukemia (CML). 2.Prior treatment with venetoclax before the diagnosis of acute myeloid leukemia. 3.A history of allogeneic hematopoietic stem cell transplantation. 4.Severe hepatic or renal impairment, defined by the presence of any of the following abnormalities: aspartate aminotransferase (AST) > 2.5 × ULN; alanine aminotransferase (ALT) > 2.5 × ULN; creatinine clearance rate 3 × ULN. 5.A history of severe cardiovascular or cerebrovascular diseases, including: myocardial infarction within 6 months prior to screening; unstable angina pectoris within 3 months prior to screening; second-degree Type II atrioventricular block or third-degree atrioventricular block during screening; hemorrhagic/ischemic stroke within 6 months prior to screening. 6.Presence of acute active infection requiring intravenous systemic therapy. 7.Presence of active malignant tumors requiring antineoplastic treatment. 8.Presence of active autoimmune diseases requiring treatment with prednisone = 15 mg/day or equivalent doses of other glucocorticoids, or any other immunosuppressive agents. 9.Inability to swallow tablets, or presence of diseases significantly impairing gastrointestinal function (e.g., malabsorption syndrome, gastrectomy or enterectomy, bariatric surgery, symptomatic inflammatory bowel disease, or partial/complete intestinal obstruction). 10.Pregnant or lactating female subjects. 11.Subjects judged by the investigator to be unable to comply with the protocol due to uncontrollable medical, psychological, familial, social, or geographic conditions; or those who are unwilling or unable to follow the required procedures of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of CR/CRi within 2 treatment courses; | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement of MRD negativity during treatment with the venetoclax plus azacitidine regimen;overall survival;Achievement of CR within 2 treatment courses;Adverse events;Relapse-free survival;Achievement of CR/CRi during treatment with the venetoclax plus azacitidine regimen; | — |
Countries
China
Contacts
Public ContactQian Jiang
Peking University People's Hospital
Outcome results
None listed