Effectiveness of Medium-Dose Cytarabine Combined With Venetoclax for Consolidation Therapy in Elderly Patients With Intermediate to High-Risk Acute Myeloid Leukemia
NCT ID: NCT06990321
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
68 participants
INTERVENTIONAL
2025-06-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Middle-and High-risk Acute Myeloid Leukemia in the Elderly
Intermediate-dose Cytarabine in Combination with Venetoclax
Elderly patients with Middle- and High-risk Acute Myeloid Leukemia who received the Intermediate-dose Cytarabine in Combination with Venetoclax at the First Hospital of Jilin University from March 1, 2024 to December 31, 2026.
Interventions
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Intermediate-dose Cytarabine in Combination with Venetoclax
Elderly patients with Middle- and High-risk Acute Myeloid Leukemia who received the Intermediate-dose Cytarabine in Combination with Venetoclax at the First Hospital of Jilin University from March 1, 2024 to December 31, 2026.
Eligibility Criteria
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Inclusion Criteria
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
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.
60 Years
75 Years
ALL
No
Sponsors
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Yehui Tan
OTHER
Responsible Party
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Yehui Tan
Professor
Locations
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The First Hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Other Identifiers
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2024-HS-084
Identifier Type: -
Identifier Source: org_study_id
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