Status:
RECRUITING
Effectiveness of Medium-Dose Cytarabine Combined With Venetoclax for Consolidation Therapy in Elderly Patients With Intermediate to High-Risk Acute Myeloid Leukemia
Lead Sponsor:
Yehui Tan
Conditions:
Acute Myeloid Leukemia (AML)
Elderly
Eligibility:
All Genders
60-75 years
Phase:
PHASE3
Brief Summary
A Single-center, Single-arm, Prospective Clinical Study of Intermediate-dose Cytarabine in Combination with Venetoclax for Consolidation Therapy of Middle- and High-risk Acute Myeloid Leukemia in the ...
Detailed Description
This study is designed to be a prospective cohort study conducted at the First Hospital of Jilin University. The target populations of this study are patients with Middle- and High-risk Acute Myeloid ...
Eligibility Criteria
Inclusion
- 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 all trial protocol requirements; 10.Able to take oral medications.
Exclusion
- 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 chemical structure 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, or inability to comply with the study treatment and examination requirements.
- 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).
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06990321
Start Date
June 1 2025
End Date
December 31 2026
Last Update
August 8 2025
Active Locations (1)
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1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000