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

ConditionsAcute Myeloid Leukemia (AML)Elderly
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60-75
SponsorYehui Tan

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

68 Participants
are divided into 1 treatment group
Group A: Middle-and High-risk Acute Myeloid Leukemia in the ElderlyExperimental treatment 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yehui Tan

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov
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