Acute Myeloid Leukemia
Conditions
Interventions
Research group:rosuvastatin combined with azacitidine and venetoclax
Control group:azacitidine and venetoclax
Sponsors
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. No gender restriction; patients with AML (as defined by the World Health Organization [WHO]) aged >=60 years; 2. Discontinue any cholesterol-lowering agents at least 7 days before the start of the trial, including any HMG-CoA reductase inhibitors, fibrates, bile acid sequestrants, or niacin; 3. Laboratory tests within 7 days prior to the first dose must meet the following requirements: (1) Liver function: total serum bilirubin =50 mL/min; (3) Coagulation function: PT =12 weeks; 5. WBC <=25 x 10^9/L within 7 days prior to the first dose (treatment with hydroxyurea or leukapheresis is allowed to achieve this standard); 6. All subjects must provide informed consent for this trial prior to participation, and voluntarily sign a written informed consent form themselves (or through a legally authorized representative); the subjects or their representatives must be able to communicate effectively with the investigators and agree to complete the trial according to the protocol; 7. Expected to tolerate the recommended dose of rosuvastatin.
Exclusion criteria
Exclusion criteria: 1.Known allergy to the investigational drug or any of its components; 2.Diagnosed acute promyelocytic leukemia, BCR/ABL-positive leukemia (blast crisis of chronic myeloid leukemia); concurrent central nervous system leukemia; secondary AML following prior chemotherapy for other malignancies (except MDS); 3.Concurrent other malignant tumors (except for cured cervical cancer at Stage IB or lower, non-invasive basal cell or squamous cell skin cancer, malignant melanoma with a continuous complete remission [CR] duration of >10 years, or other malignancies with a CR duration of >5 years); 4.Prior treatment conditions: Previous treatment with FLT3 inhibitors; prior allogeneic hematopoietic stem cell transplantation; current use of cyclosporine or fibrate drugs; participation in another clinical trial with investigational drug use within 28 days prior to the start of the study drug; major surgery within 28 days prior to the first dose of the study treatment or significant traumatic injury, or anticipated need for major surgery during the study treatment period; requirement for concomitant medications known to prolong QTc or induce Torsades de Pointes (TdP), except for antimicrobials used as standard therapy for infection prophylaxis/treatment and other such drugs deemed critical by the investigator; 5.Comorbidities: Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, peptic ulcer, etc.), or subjects with total gastrectomy, or malabsorption syndrome; uncontrolled history of epilepsy, central nervous system disorders, or psychiatric illnesses; poorly controlled hypertension (persistent systolic blood pressure =150 mmHg and/or diastolic blood pressure =100 mmHg despite antihypertensive therapy); 6.Any of the following within 12 months prior to the first dose: symptomatic congestive heart failure (New York Heart Association Class II–IV), uncontrolled arrhythmia, angina pectoris, myocardial infarction, stroke (except lacunar infarction), coronary/peripheral artery bypass graft surgery, pulmonary embolism; congenital long QT syndrome or known family history of long QT syndrome; history of left ventricular ejection fraction (LVEF) decline to below 40%; history of Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN); history of myopathies such as myalgia, myositis, or rhabdomyolysis; 7.For female subjects: Currently pregnant or breastfeeding; 8.Any past or current illness, treatment, or laboratory abnormality that may interfere with the study results, affect the subject's full participation in the study, or any other reason that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progress Free Survival; | — |
Countries
China
Contacts
Public ContactJun Shi
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed