DEC3-VEN vs. Venetoclax-Based vs. DA Regimens in Newly Diagnosed AML
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Protocol Title: A Prospective, Randomized Controlled Study of Venetoclax Plus 3-Day Decitabine (DEC3-VEN) Versus Venetoclax Plus "2+6" DA Versus "3+7" DA Regimen in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Objective: This is a prospective, open-label, randomized, multicenter, phase II trial designed to compare the efficacy and safety of three induction regimens-Venetoclax plus 3-day Decitabine (DEC3-VEN), Venetoclax plus "2+6" DA, and standard "3+7" DA-in adult patients with newly diagnosed, intensifiable AML. Study Design: The study employs a prospective, randomized, controlled, multicenter design. A total of 291 eligible patients will be enrolled across approximately 10 centers in China and randomized in a 2:2:1 ratio to the three treatment arms. Key Eligibility Criteria: Inclusion: Aged 16-65 with newly diagnosed non-APL AML (excluding favorable CBF-AML), eligible for intensive chemotherapy, ECOG ≤2, and adequate organ function. Exclusion: Prior AML treatment, secondary AML, active severe infection, significant cardiac comorbidity, or known hypersensitivity to the study drugs. Interventions: Induction: Arm A (VEN+"2+6"DA): Venetoclax (D1-8), Daunorubicin (D2-3), Cytarabine (D2-7). Arm B (DEC3-VEN): Venetoclax (D1-14), Decitabine (D4-6). FLT3/ITD+ patients add Sorafenib or Gilteritinib (D8-14). Arm C ("3+7"DA): Daunorubicin (D1-3), Cytarabine (D1-7). Consolidation (2 cycles): Arms A/B: Venetoclax + Intermediate-Dose Cytarabine. Arm C: High-Dose Cytarabine. Consolidation (Subsequent cycles): All arms receive multiple cycles of DA or HA regimens. Maintenance (6-8 cycles): Arms A/B: Venetoclax + Azacitidine. Arm C: Azacitidine. Main Outcome Measures: Primary Endpoint: Composite Complete Remission Rate (CR + CRi) after induction. Secondary Endpoints: Overall Survival (OS), CR rate, MRD-negative rate, Relapse-Free Survival (RFS), Event-Free Survival (EFS), and safety. Keywords: Acute Myeloid Leukemia, Venetoclax, Decitabine, Consolidation Therapy, Maintenance Therapy, Randomized Controlled Trial.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Biały krwinek płomykowaty diagnozowany po raz pierwszy (nie inny typ)
- •Wiek 16-65 lat
- •Stan ogólny pacjenta pozwalający na intensywne leczenie chemiczne
- •Wystarczająco sprawnie działające nerki, wątroba i serce
- •Nie było poprzedniego leczenia białaczki (z wyjątkiem małych dawek hydroksykarbamidu lub cytozyny)
- •Kobieta w wieku rozrodczym musi mieć ujemny test ciąży
- •Oczekiwana długość życia powyżej 2 miesięcy
✗ Disqualifies
- •Białaczka promiurocytarna (APL) lub białaczka z krótkim ramieniem chromosomu 8
- •Białaczka jako powikłanie poprzedniego nowotworu lub innej choroby
- •Ciężka aktywna infekcja
- •Poważne choroby serca
- •Uczulenie na badane leki
- •Poprzednie leczenie chemiczne na białaczkę
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Last updated (source)
- July 20, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
The Second Affiliated Hospital of Kunming Medical University
Kunming, China
Trial contact
ZePing Zhou
Yaxian Tan
Contact information from ClinicalTrials.gov. Contact in English.
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/21/2026.
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