Actively Recruiting
Effectiveness of Medium-Dose Cytarabine Combined With Venetoclax for Consolidation Therapy in Elderly Patients With Intermediate to High-Risk Acute Myeloid Leukemia
Led by Yehui Tan · Updated on 2025-08-08
68
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Elderly
CONDITIONS
Official Title
Effectiveness of Medium-Dose Cytarabine Combined With Venetoclax for Consolidation Therapy in Elderly Patients With Intermediate to High-Risk Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 to 75 years, any gender
- Diagnosed with acute myeloid leukemia (AML) excluding acute promyelocytic leukemia
- Classified as intermediate or high risk based on ELN 2022 guidelines
- Expected survival time of at least 3 months
- Not suitable for allogeneic hematopoietic stem cell transplantation
- Achieved remission with no leukemic involvement in bone marrow after induction therapy
- Eastern Cooperative Oncology Group Performance Status score of 0 to 2
- Laboratory tests within 7 days before treatment showing total bilirubin ≤ 1.5 times upper normal limit
- AST and ALT ≤ 2.5 times upper normal limit
- Serum creatinine less than 2 times upper normal limit
- Normal cardiac ejection fraction by echocardiogram
- Able to follow the study visit schedule and understand trial requirements
- Able to take oral medications
You will not qualify if you...
- Allergy to any drugs used in the trial or similar chemical structures
- Chemotherapy intolerance based on Ferrara 2013 criteria
- Hematologic relapse with bone marrow blasts or immature cells > 5%
- Having other active malignant tumors requiring treatment
- Known or suspected drug abuse or alcohol dependence
- Mental illness or inability to give informed consent or comply with study requirements
- Liver dysfunction with total bilirubin > 1.5 times upper normal limit or ALT/AST > 2.5 times upper normal limit (or > 5 times if liver involved)
- Kidney dysfunction with serum creatinine > 1.5 times upper normal limit
- Active heart disease including uncontrolled angina, recent myocardial infarction, arrhythmias requiring treatment, symptomatic heart failure above NYHA class 2, or low ejection fraction
- Participation in another clinical trial within 30 days
- Active infection
- Investigator considers the subject unfit for participation in this trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
Research Team
Y
Yehui Tan
CONTACT
Y
Yuying Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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