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

NCT06990321 | Recruiting Phase 3

• 1 other identifier: 2024-HS-084
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Myeloid Leukemia (AML); Elderly

Outcome Measures

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

  From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.

Secondary Outcomes (3)

• Overall Survival (OS)

  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)

  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

  From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.

Study Arms (1)

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

EXPERIMENTAL

Drug: Intermediate-dose Cytarabine in Combination with Venetoclax

Interventions

Intermediate-dose Cytarabine in Combination with Venetoclax DRUG

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.

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

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• Total bilirubin ≤ 1.5 times the upper limit of normal for the same age group;
• AST and ALT ≤ 2.5 times the upper limit of normal for the same age group;
• Serum creatinine \< 2 times the upper limit of normal for the same age group;
• 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.

You may not qualify if:

• Subjects who meet any of the following criteria shall not be included in this study:
• Allergic to any drugs included in the trial protocol or drugs with a chemical structure similar to the investigational drug.
• Chemotherapy intolerance assessed by Ferrara 2013 criteria prior to enrollment.
• Hematologic relapse (bone marrow blasts or immature cells exceed 5%).
• Simultaneous diagnosis of other malignant tumors in organs (requiring treatment).
• Known or suspected drug abuse or alcohol dependence.
• Mental illness or any condition that prevents obtaining informed consent, or inability to comply with the study treatment and examination requirements.
• 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).
• Active heart disease, defined as one or more of the following:
• \) 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.
• \) 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.

Sponsors & Collaborators

• Yehui Tan: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Yehui Tan

CONTACT

+8615948027438; yhtan@jlu.edu.cn

Yuying Li

CONTACT

+8613944135650; lyying1001@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

CN (1)