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RecruitingNCT06990321Updated Aug 8, 2025

Effectiveness of Medium-Dose Cytarabine Combined With Venetoclax for Consolidation Therapy in Elderly Patients With Intermediate to High-Risk Acute Myeloid Leukemia

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

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
60 Years to 75 Years
Sex
All
01

Study 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 Elderly

Read 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 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

02

Conditions studied

  • Acute Myeloid Leukemia (AML)
  • Elderly
03

In context

Leukemia, Myeloid, Acute

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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):

  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

Exclusion Criteria:

Subjects who meet any of the following criteria shall not be included in this study:

  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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Middle-and High-risk Acute Myeloid Leukemia in the Elderly

    Drug: Intermediate-dose Cytarabine in Combination with Venetoclax

Interventions

  • DrugIntermediate-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.

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

07

Study locations

1 of 1 sites recruiting
  • The First Hospital of Jilin University
    Changchun, Jilin 130000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06990321
Lead sponsor
Yehui Tan
Responsible party
Yehui Tan (Professor, The First Hospital of Jilin University) — Sponsor-investigator
First posted
May 25, 2025
Start date
Jun 1, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 8, 2025

Study contacts

Yehui Tan
Contact
yhtan@jlu.edu.cn
+8615948027438
Yuying Li
Contact
lyying1001@jlu.edu.cn
+8613944135650

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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