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Leukemia, Myeloid, AcuteNCT06697327

Daunorubicin + Cytarabine + Venetoclax in de Novo AML

A study testing (Daunorubicin, Cytarabine, Venetoclax) and (Daunorubicin, Cytarabine) in people with Leukemia, Myeloid, Acute and Acute Myeloid Leukemia, run by Anhui Medical University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 59 years
What is being tested?
(Daunorubicin, Cytarabine, Venetoclax) and (Daunorubicin, Cytarabine)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteChina
Study dates
1 Feb 2025to 1 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

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

    Hefei, Anhui, 230022

Other trials in China

About this study

Official title: 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.

Read the 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.
Being tested
(Daunorubicin, Cytarabine, Venetoclax), (Daunorubicin, Cytarabine)
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • (Daunorubicin, Cytarabine, Venetoclax)Drug

    • 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

  • (Daunorubicin, Cytarabine)Drug

    • 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
Study groups in NCT06697327
Study groupRoleWhat they receive
Treatment(Daunorubicin, Cytarabine, Ventoclax)ExperimentalTreatment(Daunorubicin, Cytarabine, Ventoclax) See Detailed Description.
Receives: Drug: (Daunorubicin, Cytarabine, Venetoclax)
Control(Daunorubicin, Cytarabine)Active comparatorControl(Daunorubicin, Cytarabine) See Detailed Description.
Receives: Drug: (Daunorubicin, Cytarabine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    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.

    Measured: End of cycle 2 (each cycle is 14 days)

Secondary outcomes (4)

  1. Overall survival (OS)

    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.

    Measured: 1-Year Follow-up

  2. Event-free survival (EFS)

    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.

    Measured: 1-Year Follow-up

  3. duration of remission (DOR)

    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.

    Measured: 1-Year Follow-up

  4. Incidence of adverse events

    Incidence of adverse events will be defined by Grade 3-4 clinical adverse events (AEs), incidence of laboratory abnormalities, and treatment-related mortality (TRM).

    Measured: 1-Year Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2024
  2. Study start1 Feb 2025
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06697327
Sponsor's protocol ID
PJ 2023-09-19
Status last verified
May 2025
First submitted
12 Nov 2024
Last updated
14 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing (Daunorubicin, Cytarabine, Venetoclax) and (Daunorubicin, Cytarabine) in people with Leukemia, Myeloid, Acute and Acute Myeloid Leukemia, run by Anhui Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: End of cycle 2 (each cycle is 14 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06697327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

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