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

Last updated: May 23, 2025
Sponsor: Yehui Tan
Overall Status: Active - Not Recruiting

Phase

3

Condition

Aging

Leukemia

Leukemia (Pediatric)

Treatment

Intermediate-dose Cytarabine in Combination with Venetoclax

Clinical Study ID

NCT06990321
2024-HS-084
  • Ages 60-75
  • All Genders

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

Eligibility Criteria

Inclusion

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 alltrial protocol requirements; 10.Able to take oral medications.

Exclusion

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 chemicalstructure 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, orinability to comply with the study treatment and examination requirements.

  7. Liver dysfunction (total bilirubin >1.5×ULN, ALT/AST >2.5×ULN, orliver-involved patients with ALT/AST >5×ULN), kidney dysfunction (serumcreatinine >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 6months prior to enrollment. 3) History of arrhythmias requiring drug treatment orwith severe clinical symptoms.

  2. Uncontrolled or symptomatic congestive heart failure (>NYHA class 2). 5) Ejectionfraction below the lower limit of normal. 9.Participation in another clinical trialwithin 30 days. 10.Active infection. 11.The investigator deems the subject unfit forparticipation in this trial.

Study Design

Total Participants: 68
Treatment Group(s): 1
Primary Treatment: Intermediate-dose Cytarabine in Combination with Venetoclax
Phase: 3
Study Start date:
June 01, 2025
Estimated Completion Date:
December 31, 2026

Study 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