Clinical trial · Interventional
Daunorubicin + Cytarabine + Venetoclax in de Novo AML
Daunorubicin Plus Cytarabine 3+5 Regimen Combined With Venetoclax in de Novo Patients With Acute Myeloid Leukemia: a Single Center, Open-label, Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| (Daunorubicin, Cytarabine) | Drug | — | UNRESOLVED |
| (Daunorubicin, Cytarabine, Venetoclax) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment(Daunorubicin, Cytarabine, Ventoclax)
- description
- Treatment(Daunorubicin, Cytarabine, Ventoclax) See Detailed Description.
- interventionNames
- Drug: (Daunorubicin, Cytarabine, Venetoclax)
- type
- ACTIVE_COMPARATOR
- label
- Control(Daunorubicin, Cytarabine)
- description
- Control(Daunorubicin, Cytarabine) See Detailed Description.
- interventionNames
- Drug: (Daunorubicin, Cytarabine)
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- End of cycle 2 (each cycle is 14 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available