A Phase 3 interventional study of Intermediate-dose Cytarabine in Combination with Venetoclax in Acute Myeloid Leukemia (AML) and Elderly, sponsored by Yehui Tan. Recruiting at 1 site in China. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Yehui Tan · Phase 3, Interventional, and Treatment
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
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 Leukemia in the elderly who received intermediate-dose cytarabine in combination with venetoclax for consolidation therapy from June 1, 2025to December 31, 2026. It is expected to enroll 68 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected, and statistical analysis of data will be conducted to compare the effectiveness outcome measures
2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.
This study's planned enrollment of 68 is above the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Yehui Tan is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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):
Exclusion Criteria:
Subjects who meet any of the following criteria shall not be included in this study:
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.
Drug: 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.
Relapse-Free Survival(RFS)
Defined as the time from enrollment in this study to the occurrence of relapse. For patients without relapse, the time is calculated until death from any cause or the time of the last follow-up
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
Overall Survival (OS)
Defined as the time from enrollment in this study to death from any cause. If the exact date of death is unknown, the time of death is defined as the last contact date. If the patient is still alive, the last observed time will be used, and the patient's OS will be considered for analysis.
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
Cumulative Relapse Rate (CIR)
Defined as the proportion of patients who experience disease relapse from the time of enrollment in this study.
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
MRD Negative Conversion Rate
Defined as the proportion of patients who convert to MRD negative among all evaluable patients for efficacy.
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
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