Daunorubicin + Cytarabine + Venetoclax in de Novo AML

May 10, 2025 updated by: Zhangbiao Long, Anhui Medical University

Daunorubicin Plus Cytarabine 3+5 Regimen Combined With Venetoclax in de Novo Patients With Acute Myeloid Leukemia: a Single Center, Open-label, Controlled Study

This study is a non-profit, prospective, single-center, open-label, controlled clinical trial aimed at evaluating the efficacy of the daunorubicin, cytarabine, and venetoclax (DAV) regimen in previously untreated adult AML patients eligible for intensive chemotherapy.The combination of daunorubicin administered for 3 consecutive days and cytarabine for 7 consecutive days constitutes the classic "3+7" induction chemotherapy regimen for AML patients eligible for chemotherapy. The addition of venetoclax to the "3+7" regimen has shown promising efficacy in newly diagnosed AML patients suitable for intensive therapy. However, this approach is associated with increased adverse reactions. Based on current clinical studies, we propose a modified approach involving reduced-dose chemotherapy combined with venetoclax for AML treatment, aiming to achieve optimal efficacy while effectively reducing adverse reactions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVE:

1. To evaluate the efficacy of the regimen, as defined by complete remission (CR), complete remission with partial hematologic recovery (CRh), complete remission with incomplete hematologic recovery (CRi), morphological leukemia-free state (MLFS), and partial remission (PR).

SECONDARY OBJECTIVES:

  1. To evaluate the long-term effectiveness and durability of the treatment of the regimen, as defined by 1-year overall survival (OS), 1-year event-free survival (EFS), and duration of remission (DOR).
  2. To evaluate the safety of the regimen, as defined by Grade 3-4 clinical adverse events (AEs), incidence of laboratory abnormalities, and treatment-related mortality (TRM).

OUTLINE:

  • The regimen for the control group includes:(Daunorubicin, Cytarabine)

    • Daunorubicin: 60 mg/(m²·d) on days 1 to 3
    • Cytarabine: 100 mg/(m²·d) on days 1 to 7

  • The experimental group's "DAV" regimen includes: (Daunorubicin, Cytarabine, Venetoclax)

    • Daunorubicin: 40 mg/(m²·d) on days 1 to 3
    • Cytarabine: 100 mg/(m²·d) on days 1 to 5
    • Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg from days 3 to 14
  • The "DAV" regimen is designed to shorten the duration of induction chemotherapy while extending the application period of venetoclax, aiming to improve efficacy while reducing adverse effects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment(Daunorubicin, Cytarabine, Ventoclax)
Treatment(Daunorubicin, Cytarabine, Ventoclax) See Detailed Description.
Drug: (Daunorubicin, Cytarabine, Venetoclax)

  • Drugs：Daunorubicin

    • Dosage: 40 mg/(m²·d) on days 1 to 3
    • Other names: Cerubidine, Daunomycin, Rubidomycin

  • Drugs：Cytarabine

    • Dosage: 100 mg/(m²·d) on days 1 to 5
    • Other names: Ara-C, Cytosine Arabinoside, Cytosar-U

  • Drugs：Venetoclax

    • Dosage: 100 mg on day 1, 200 mg on day 2, and 400 mg from days 3 to 14
    • Other names: ABT-199, Venclexta, Venclyxto
Active Comparator: Control(Daunorubicin, Cytarabine)
Control(Daunorubicin, Cytarabine) See Detailed Description.
Drug: (Daunorubicin, Cytarabine)

  • Drugs：Daunorubicin

    • Dosage: 60 mg/(m²·d) on days 1 to 3
    • Other names: Cerubidine, Daunomycin, Rubidomycin

  • Drugs：Cytarabine

    • Dosage: 100 mg/(m²·d) on days 1 to 7
    • Other names: Ara-C, Cytosine Arabinoside, Cytosar-U

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: End of cycle 2 (each cycle is 14 days)
Defined as the proportion of patients achieving complete remission (CR), complete remission with partial hematologic recovery (CRh), complete remission with incomplete hematologic recovery (CRi), morphological leukemia-free state (MLFS), and partial remission (PR) occurring at the end of 2 cycles of treatment. Will be estimated along with the 95% credible interval. Patients who drop out of the study before completing 2 cycles and have been treated will be censored for the primary endpoint analysis.
End of cycle 2 (each cycle is 14 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 1-Year Follow-up
Overall survival (OS) is defined as the time from randomization to death from any cause. Patients who are alive at the time of the last follow-up will be censored at the date of last contact. OS will be estimated using Kaplan-Meier methods, with median survival and 95% confidence intervals reported for each treatment group.
1-Year Follow-up
Event-free survival (EFS)
Time Frame: 1-Year Follow-up
Event-Free Survival (EFS) is defined as the time from randomization to the first occurrence of disease progression, relapse, new cancer occurrence, or death from any cause. Patients who remain event-free at the last follow-up will be censored at the date of last contact. EFS will be estimated using Kaplan-Meier methods, with median EFS and 95% confidence intervals reported for each treatment group.
1-Year Follow-up
duration of remission (DOR)
Time Frame: 1-Year Follow-up
Duration of Remission (DOR) is defined as the time from the first documentation of complete or partial remission until disease progression or relapse. Patients who remain in remission at the last follow-up will be censored at the date of last contact. DOR will be estimated using Kaplan-Meier methods, with median DOR and 95% confidence intervals reported for each treatment group.
1-Year Follow-up
Incidence of adverse events
Time Frame: 1-Year Follow-up
Incidence of adverse events will be defined by Grade 3-4 clinical adverse events (AEs), incidence of laboratory abnormalities, and treatment-related mortality (TRM).
1-Year Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anhui Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Anhui Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: ZhangBiao Long, Doctor, Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PJ 2023-09-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data Privacy and Ethical Restrictions: The individual participant data collected in this study involves sensitive information. Although de-identification processes have been applied, further measures are required to ensure compliance with relevant ethical standards and data privacy regulations, such as GDPR. We are currently working with ethical committees and relevant authorities to develop a compliant data-sharing strategy.

Data Quality and Preparation: The data has not yet undergone complete standardization and cleaning processes, and it may not meet the high-quality standards required for sharing. To ensure data accuracy and usability, we plan to consider data sharing once data processing and annotation are fully completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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