Enrolling by invitation

Daunorubicin, Cytarabine, and Venetoclax for Acute Myeloid Leukemia

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What is being tested

(Daunorubicin, Cytarabine, Venetoclax)

+ (Daunorubicin, Cytarabine)

Drug
Who is being recruted

Hematologic Diseases+4

+ Hemic and Lymphatic Diseases

+ Leukemia

From 18 to 59 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorAnhui Medical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is investigating a new treatment approach for patients who have just been diagnosed with Acute Myeloid Leukemia (AML). The study compares two treatment regimens: a standard combination of the drugs Daunorubicin and Cytarabine, and an experimental regimen that adds a third drug, Venetoclax, to the mix. The goal is to see if the addition of Venetoclax can improve the chances of achieving remission while potentially causing fewer side effects. This research is important because it could lead to better outcomes for people with AML, a serious type of blood cancer. The study involves two groups of participants. One group receives the standard treatment of Daunorubicin and Cytarabine, while the other group receives a slightly altered version of this treatment with added Venetoclax. Participants in the experimental group take Daunorubicin for three days, Cytarabine for five days, and Venetoclax for up to fourteen days. This study measures various aspects of treatment success, such as complete remission rates and long-term survival. It also monitors safety by tracking any severe side effects or issues that arise during the treatment. The aim is to find a balance between effectiveness and safety in treating AML.

Official TitleDaunorubicin Plus Cytarabine 3+5 Regimen Combined With Venetoclax in de Novo Patients With Acute Myeloid Leukemia: a Single Center, Open-label, Controlled Study
NCT06697327
Principal SponsorAnhui Medical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

94 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 59 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidNeoplasmsNeoplasms by Histologic TypeLeukemia, Myeloid, Acute

Criteria

Inclusion Criteria:(All of the following criteria must be met.) Patients with newly diagnosed AML based on FAB classification and flow cytometry standards who are eligible for intensive chemotherapy: * Age between 18 and 59 years; * Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3; * Expected survival time of ≥3 months; * None of the following severe cardiac, pulmonary, hepatic, or renal conditions: * History of heart disease requiring treatment for congestive heart failure, or an ejection fraction ≤50%, or chronic stable angina; * Pulmonary diffusing capacity of carbon monoxide (DLCO) ≤65%, or forced expiratory volume in 1 second (FEV1) ≤65%; * Moderate liver impairment with total bilirubin \>1.5 to ≤3.0 × the upper limit of normal (ULN); * Creatinine clearance ≥30 mL/min to \<45 mL/min; * Has not received radiotherapy, chemotherapy, targeted therapy, or hematopoietic stem cell transplantation within 4 weeks prior to enrollment; * Has other comorbidities that, in the physician's judgment, make intensive chemotherapy unsuitable; * Is capable of understanding and willing to sign the informed consent form for this study. Exclusion Criteria:(Any of the following criteria will exclude the patient from participation) * Presence of other malignancies; * Prior treatment with venetoclax or azacitidine; * History of angioplasty or stent placement within 12 months prior to signing the informed consent, or a history of myocardial infarction, unstable angina, or other clinically significant heart disease; * Clinically uncontrolled active infection (including bacterial, fungal, or viral infections); * Pregnant or breastfeeding women; * Participation in any other clinical trial within 3 months prior to signing the informed consent; * Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Treatment(Daunorubicin, Cytarabine, Ventoclax) See Detailed Description.

Group II

Active Comparator
Control(Daunorubicin, Cytarabine) See Detailed Description.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road

Hefei, ChinaOpen Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road in Google Maps
Enrolling by invitationOne Study Center