Phase
Condition
Aging
Leukemia
Leukemia (Pediatric)
Treatment
Intermediate-dose Cytarabine in Combination with Venetoclax
Clinical Study ID
Ages 60-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
1.Age ≥ 60 years and ≤ 75 years, regardless of gender; 2.Diagnosed with AML (acute myeloid leukemia) according to WHO criteria (non-acute promyelocytic leukemia); 3.Risk stratification as intermediate or high risk based on the ELN (2022) guidelines; 4.Expected survival time ≥ 3 months; 5.Not suitable for allogeneic hematopoietic stem cell transplantation; 6.AML patients who achieve remission with morphologic assessment of bone marrow showing no leukemic involvement after induction therapy; 7.Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2; 8.Meeting the following laboratory requirements (performed within 7 days prior to treatment):
Total bilirubin ≤ 1.5 times the upper limit of normal for the same age group;
AST and ALT ≤ 2.5 times the upper limit of normal for the same age group;
Serum creatinine < 2 times the upper limit of normal for the same age group;
Cardiac ejection fraction within normal limits as determined by echocardiogram. 9.Able to comply with the study visit schedule and understand and adhere to alltrial protocol requirements; 10.Able to take oral medications.
Exclusion
Exclusion Criteria:
Subjects who meet any of the following criteria shall not be included in this study:
Allergic to any drugs included in the trial protocol or drugs with a chemicalstructure similar to the investigational drug.
Chemotherapy intolerance assessed by Ferrara 2013 criteria prior to enrollment.
Hematologic relapse (bone marrow blasts or immature cells exceed 5%).
Simultaneous diagnosis of other malignant tumors in organs (requiring treatment).
Known or suspected drug abuse or alcohol dependence.
Mental illness or any condition that prevents obtaining informed consent, orinability to comply with the study treatment and examination requirements.
Liver dysfunction (total bilirubin >1.5×ULN, ALT/AST >2.5×ULN, orliver-involved patients with ALT/AST >5×ULN), kidney dysfunction (serumcreatinine >1.5×ULN).
Active heart disease, defined as one or more of the following:
History of uncontrolled or symptomatic angina. 2) Myocardial infarction within 6months prior to enrollment. 3) History of arrhythmias requiring drug treatment orwith severe clinical symptoms.
Uncontrolled or symptomatic congestive heart failure (>NYHA class 2). 5) Ejectionfraction below the lower limit of normal. 9.Participation in another clinical trialwithin 30 days. 10.Active infection. 11.The investigator deems the subject unfit forparticipation in this trial.