Actively Recruiting
Effectiveness of Intermediate-Dose Cytarabine Combined With Venetoclax for Consolidation Therapy in Elderly Patients With Middle- and High-Risk Acute Myeloid Leukemia
Led by Yehui Tan · Updated on 2025-08-08
68
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of intermediate-dose cytarabine combined with venetoclax as consolidation therapy for elderly patients aged 60 to 75 years with middle- and high-risk acute myeloid leukemia (AML). This prospective, single-center, phase 3 study at the First Hospital of Jilin University aims to collect and analyze data on patient demographics, medications, and prognosis to assess treatment effectiveness. Participants will receive intermediate-dose cytarabine together with venetoclax as consolidation therapy. The study will enroll about 68 subjects from June 1, 2025, to December 31, 2026. This single-arm trial involves treatment and follow-up within this timeframe to evaluate outcomes related to relapse and survival. During the study, researchers will monitor relapse-free survival up to 36 months from treatment start, along with overall survival, cumulative relapse rate, and minimal residual disease negative conversion rate. Participants will be assessed regularly for disease progression and other health parameters, including liver, kidney, and heart function. Data collection includes baseline characteristics and ongoing monitoring to support the study's statistical analysis of outcomes.
CONDITIONS
Brief 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 between 60 and 75 years, any gender
- Diagnosed with acute myeloid leukemia (AML) according to WHO criteria, 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 by bone marrow assessment after induction therapy
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0 to 2
- Laboratory tests within 7 days before treatment showing total bilirubin ≤1.5 times normal, AST and ALT ≤2.5 times normal, serum creatinine less than 2 times normal, and normal cardiac ejection fraction
- Able to comply with study visits and understand the protocol
- Able to take oral medications
You will not qualify if you...
- Allergy to any drugs in the trial or chemically similar drugs
- Chemotherapy intolerance as assessed by Ferrara 2013 criteria
- Hematologic relapse with bone marrow blasts or immature cells over 5%
- Diagnosis of other active malignant tumors requiring treatment
- Known or suspected drug abuse or alcohol dependence
- Mental illness or conditions preventing informed consent or study compliance
- Liver dysfunction with total bilirubin >1.5×ULN, ALT/AST >2.5×ULN, or liver-involved patients with ALT/AST >5×ULN
- Kidney dysfunction with serum creatinine >1.5×ULN
- Active heart disease including uncontrolled angina, recent myocardial infarction (within 6 months), arrhythmias needing treatment, symptomatic congestive heart failure above NYHA class 2, or low ejection fraction
- Participation in another clinical trial within 30 days
- Active infection
- Investigator judgment deeming unfit for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From start of consolidation therapy until completion, up to approximately 2 years and 10 months
Participants receive intermediate-dose cytarabine combined with venetoclax as consolidation therapy for acute myeloid leukemia.
Visit frequency is based on treatment schedule and clinical needs
Duration - Up to 36 months from date of index treatment
Participants are monitored for relapse-free survival, overall survival, and other outcomes after treatment ends.
Visit frequency depends on clinical follow-up schedule
Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
Research Team
Y
Yehui Tan
Y
Yuying Li
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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