acute myeloid leukemia
Conditions
Interventions
Modify DAV group:Modified DAV scheme (daunorubicin 60mg/m2/d, qd, intravenous injection, d1~d2, Cytarabine 100mg/m2/d, qd, intravenous injection, d1~d5, venetoclax 100mg d3, 200mg d4, 400mg d5~d10, qd
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
60 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Patients with a confirmed diagnosis of previously untreated de novo AML according to the criteria presented by 2022 WHO. 2) Patients aged 60-79 years. 3) Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Appendix1). 4) Patients were required to have left ventricular ejection fraction of = 45% by echocardiography. 5) Patients were required to have creatinine clearance = 50mL/min by Cockcroft-Gault formula or 24-hour urine samples. 6) Patients were required to have aspartate amino transferase (AST) =2.5×ULN*; alanine aminotransferase (ALT) =2.5×ULN*; Serum total bilirubin = 1.5×ULN* (* unless believed to be due to the Leukemia infiltration).
Exclusion criteria
Exclusion criteria: 1) Secondary AML 2) Acute promyelocytic leukemia (APL) 3) Patients already pretreated with anthracyclines. 4) AML patients had known central nervous system (CNS) involvement 5) Patients were known to be positive for HIV (due to the possible drug-drug interaction of antiretroviral drugs with venetoclax). HIV tests were conducted before the screening of the study patients following the local guiding principles or institutional standard requirements. 6) Patients were known to be positive for hepatitis B virus (HBV), or hepatitis C virus (HCV). Inactive hepatitis carriers or patients with low viral hepatitis virus titer after treatment with non-prohibited antiviral drug shall not be excluded. 7) Patients received treatment with strong or moderate CYP3A inducers or inhibitors, strong P-gp inhibitor therapy, or related foods within 7 days before study treatment (inducers or inhibitors were presented in Table S3). 8) Patients had a New York Heart Association cardiovascular disability status higher than grade 2 (grade 2 is defined as cardiac disorder that is asymptomatic at rest, but ordinary physical activity might result in fatigue, palpitations, dyspnea, or angina) 9) Patients had chronic respiratory diseases requiring continuous supplementary oxygen. 10) Patients unable to take oral medication or malabsorption syndrome. 11) Patients had uncontrollable systemic infection (viral, bacterial, or fungal). 12) Patients who have been or are currently undergoing any anti-leukemia agents (excluding those prescribed by the protocol) or participating in clinical research. 13)Patients who are allergic to the study agents or allergic to allopurinol that may need to be used or unable to take uric acid-lowering drugs. 14) Patients unable to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite complete remission after one cycle; | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite complete remission after two cycles;Hematology and non Hematology adverse reactions;Measurable residual disease;Event-free survival;Relapse-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactJin Jie
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed