Tests daunorubicin, cytarabine and venetoclax for newly diagnosed acute myeloid leukemia
Tests a chemotherapy plus venetoclax combination in adults newly diagnosed with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Daunorubicin + Cytarabine + Venetoclax in de Novo AML
Key facts
- Where
- Hefei, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 59 with newly diagnosed acute myeloid leukemia (AML) who can have intensive chemotherapy.
- Age
- 18 to 59 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed AML (FAB classification and flow cytometry), not treated before. ECOG performance status score of 2 or 3. Expected survival of at least 3 months.
- Earlier treatment
- No radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation within 4 weeks before joining. No earlier treatment with venetoclax or azacitidine.
Main reasons for not taking part
- Another cancer
- Earlier treatment with venetoclax or azacitidine
- Angioplasty or stent within 12 months, or myocardial infarction, unstable angina or other significant heart disease
- Active infection that is not under control
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 59 years old?
Source: NCT06697327, who can take part
Where in China
- Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi RoadHefei, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Anhui Medical University
- Trial code
- NCT06697327
- Record updated
- 14 May 2025
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: 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; Participation in any other clinical trial within 3 months prior to signing the informed consent; Presence of other malignancies; Clinically uncontrolled active infection (including bacterial, fungal, or viral infections); Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study; Pregnant or breastfeeding women.