Effectiveness of Medium-Dose Cytarabine Combined With Venetoclax for Consolidation Therapy in Elderly Patients With Intermediate to High-Risk Acute Myeloid Leukemia

Launched by YEHUI TAN · May 23, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a treatment combining medium-dose Cytarabine and Venetoclax for elderly patients with a type of blood cancer called Acute Myeloid Leukemia (AML). Specifically, it focuses on patients aged 60 to 75 years who have been diagnosed with intermediate to high-risk AML and have achieved remission after initial treatment. The study aims to see how well this combination therapy works as a follow-up treatment, known as consolidation therapy, to help prevent the cancer from coming back.

To be eligible for this trial, participants must be between 60 and 75 years old, have a confirmed diagnosis of AML, and meet certain health criteria, including being able to take oral medications and having a good performance status. Patients with other serious health issues or those who cannot participate in the study for various reasons will be excluded. While the trial is not yet recruiting participants, those who join can expect close monitoring and support throughout their treatment journey. This study is important as it may provide new insights into effective treatments for older patients facing this challenging disease.

Gender

ALL

Eligibility criteria

• 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):
• • 1. Total bilirubin ≤ 1.5 times the upper limit of normal for the same age group;
• • 2. AST and ALT ≤ 2.5 times the upper limit of normal for the same age group;
• • 3. Serum creatinine \< 2 times the upper limit of normal for the same age group;
• • 4. Cardiac ejection fraction within normal limits as determined by echocardiogram. 9.Able to comply with the study visit schedule and understand and adhere to all trial protocol requirements; 10.Able to take oral medications.
• Exclusion Criteria:
• Subjects who meet any of the following criteria shall not be included in this study:
• • 1. Allergic to any drugs included in the trial protocol or drugs with a chemical structure similar to the investigational drug.
• • 2. Chemotherapy intolerance assessed by Ferrara 2013 criteria prior to enrollment.
• • 3. Hematologic relapse (bone marrow blasts or immature cells exceed 5%).
• • 4. Simultaneous diagnosis of other malignant tumors in organs (requiring treatment).
• • 5. Known or suspected drug abuse or alcohol dependence.
• • 6. Mental illness or any condition that prevents obtaining informed consent, or inability to comply with the study treatment and examination requirements.
• • 7. Liver dysfunction (total bilirubin \>1.5×ULN, ALT/AST \>2.5×ULN, or liver-involved patients with ALT/AST \>5×ULN), kidney dysfunction (serum creatinine \>1.5×ULN).
• 8. Active heart disease, defined as one or more of the following:
• • 1) History of uncontrolled or symptomatic angina. 2) Myocardial infarction within 6 months prior to enrollment. 3) History of arrhythmias requiring drug treatment or with severe clinical symptoms.
• • 4) Uncontrolled or symptomatic congestive heart failure (\>NYHA class 2). 5) Ejection fraction below the lower limit of normal. 9.Participation in another clinical trial within 30 days. 10.Active infection. 11.The investigator deems the subject unfit for participation in this trial.