OncoMatch/Clinical Trials/NCT07712848
DEC3-VEN vs. Venetoclax-Based vs. DA Regimens in Newly Diagnosed AML
Is NCT07712848 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies non-drug interventions for aml (acute myeloid leukemia).
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: BCR-ABL1 fusion
AML with BCR-ABL1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: AML induction chemotherapy
Treated patients (refers to those who have received induction chemotherapy in the past, regardless of the efficacy)
Lab requirements
Kidney function
Creatinine ≥ 30 mL/min (Cockcroft Gault or 24-hour urine)
Liver function
ALT, AST, ALP ≤3× ULN; serum bilirubin ≤2× ULN; serum cardiac enzymes <2.0× ULN unless due to leukemic organ involvement
Cardiac function
No active cardiac disease (recent MI, arrhythmias requiring medication, uncontrolled/symptomatic CHF > NYHA 2, uncontrolled/symptomatic angina, LVEF below normal)
ALT, AST, ALP ≤3× ULN; serum bilirubin ≤2× ULN; serum cardiac enzymes <2.0× ULN unless due to leukemic organ involvement. Creatinine ≥ 30 mL/min. Active cardiac disease, defined as one or more of: MI <6 months, arrhythmias requiring medication, uncontrolled/symptomatic CHF > NYHA 2, uncontrolled/symptomatic angina, LVEF below normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07712848 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with BCR-ABL1 alterations eligible?
No. BCR-ABL1 fusion is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 65 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages