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.
Inclusion Criteria:
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Subjects who are suitable for enrollment in this study must meet all of the following criteria:
1) Aspartate aminotransferase (ALT), alanine aminotransferase (AST) and alkaline phosphatase (ALP) ≤3× upper limit of normal (ULN), serum bilirubin ≤2×ULN; Serum cardiac enzymes < 2.0× ULN; Unless it is thought to be a leukemic organ involvement.
Creatinine ≥ 30 mL/min, calculated by the Cockcroft Gault formula or measured by 24-hour urine collection;
7. Female subjects of childbearing potential must have a negative pregnancy test result within 72 hours before the start of treatment; Not planning to become pregnant during the study and within 6 months after the last dose of study drug, and negative urine or serum pregnancy test results at screening. Men must use a latex condom during any sexual contact with WOCBP, even if they have had a successful vasectomy, and must agree to avoid childbearing (during treatment and for 6 months after the last dose of study drug).
8. Life expectancy exceeds 2 months;
9. Informed consent must be signed before the start of all specific study procedures, and the informed consent form must be signed by the patient or his immediate family; Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the legal guardian or the patient's immediate family will sign the informed consent form.
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible for this study:
12. Patients with severe infectious diseases (uncured tuberculosis, pulmonary aspergillosis), known infection with human immunodeficiency virus (HIV) or active hepatitis B or C; Subjects with uncontrollable infection.
13. Subjects with evidence of central nervous system leukemia before treatment;
14. Subjects with epilepsy, dementia or other abnormal mental states that require medication and cannot understand or follow the protocol;
15. Restriction of oral drug intake or gastrointestinal absorption;
16. Those who are not suitable for enrollment in the opinion of the investigator;
zhouzeping@kmmu.edu.cn+8618788571605
(VEN+"2+6"DA)
(DEC3-VEN)
("3+7"DA)
353964619@qq.com+8618208821198
Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML
Comparison of the Efficacy and Safety of Venetoclax in Combination With 3 Days Decitabine (DEC3-VEN) vs. Venetoclax in Combination With Azacitidine (VIALE-A) in the Treatment of Elderly Patients or Unfit, New-diagnosis Acute Myeloid Leukemia Patients
Safety and Efficacy of Venetoclax Combination With Decitabine(DEC3-VEN) in the Treatment of AML in the Adult
Study on the Efficacy and Safety of VA Regimen Compared to "3+7" Regimen in Newly Diagnosed AML With NPM1 or IDH1/IDH2 Mutations
Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML
Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML
Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML
A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients