DEC3-VEN vs. Venetoclax-Based vs. DA Regimens in Newly Diagnosed AML

NCT07712848 | Recruiting Phase 3

• 1 other identifier: 2ndKunmingMC
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

AML (Acute Myeloid Leukemia)

Keywords

Acute Myeloid Leukemia; Venetoclax; Decitabine; DA regimen; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Composite Complete Remission Rate after Induction Therapy

  Percentage of patients achieving composite complete remission (CR + CRi) after induction therapy (defined as the first 28-day cycle of treatment). Complete remission (CR) and CR with incomplete hematologic recovery (CRi) are defined according to the European LeukemiaNet (ELN) 2022 criteria. Response is assessed by bone marrow aspiration and biopsy performed at a central laboratory between Day 21 and Day 28 of the induction cycle (or upon count recovery). The measurement unit is the percentage of patients achieving CR or CRi among all randomized patients (intention-to-treat population).

  At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (5)

• Overall Survival (OS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

• MRD-negative remission rate

  At the end of Cycle 1 (each cycle is 28 days)

• Relapse-Free Survival (RFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

• Event-Free Survival (EFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

• safety profile

  At the end of Cycle 1 (each cycle is 28 days)

Study Arms (3)

Arm A

EXPERIMENTAL

(VEN+"2+6"DA)

Procedure: Arm A (VEN+"2+6"DA)

Arm B

EXPERIMENTAL

(DEC3-VEN)

Procedure: Arm B (DEC3-VEN)

Arm C

EXPERIMENTAL

("3+7"DA)

Procedure: Arm C ("3+7"DA)

Interventions

Arm B (DEC3-VEN) PROCEDURE

Venetoclax (Days 1-14), Decitabine (Days 4-6). FLT3/ITD-positive patients receive additional Sorafenib or Gilteritinib (Days 8-14).

Arm B

Arm C ("3+7"DA) PROCEDURE

Daunorubicin (Days 1-3), Cytarabine (Days 1-7)

Arm C

Arm A (VEN+"2+6"DA) PROCEDURE

Venetoclax (Days 1-8), Daunorubicin (Days 2-3), Cytarabine (Days 2-7)

Arm A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are suitable for enrollment in this study must meet all of the following criteria:
• Except for APL or carrying t(8) that meet the diagnostic criteria (WHO2022 criteria) of the World Health Organization; 21)/(RUNX1::RUNX1TI)、inv(16)(p13.1q22) 、 t(16; 16) (p13.1q22) 、 t(16; 16)/CBFβ::myh11) and other acute myeloid leukemia other than one of the abnormal karyotypes;
• Except for acute panmyeloproliferative disease with myelofibrosis and myeloid sarcoma, the World Health Organization AML classification is AML without separate classification;
• Newly diagnosed AML patients with male or female, age greater than or equal to 16 years old and less than 65 years old, patients are considered suitable for intensive chemotherapy;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at the time of enrollment;
• The patient has not received previous AML therapy (except for hydroxyurea and Ara-C\<1.0g/d for reducing tumor compounds);
• Pass the following laboratory test indicators (performed within 7 days before treatment):
• \) 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;
• \. 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).
• \. Life expectancy exceeds 2 months;
• \. 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.

You may not qualify if:

• Subjects who meet any of the following criteria are not eligible for this study:
• AML with BCR-ABL1; or CML sudden change period;
• Treated patients (refers to those who have received induction chemotherapy in the past, regardless of the efficacy);
• Subjects with acute panmyelopathy with myelofibrosis or myelosarcoma as defined by WHO 2016;
• Secondary leukemia (mainly refers to those who belong to the treatment-related AML subcategory of the World Health Organization (WHO 2016) AML classification and those with a history of pre-stage MDS and/or MPD);
• Pregnant or lactating patients;
• Those who are allergic to any drugs involved in this study;
• Use of strong or moderate CYP7A inducers within 3 days before the start of study treatment;
• Suffering from malignant tumors of other organs (those who need treatment);
• Obvious abnormal liver and kidney function, exceeding the enrollment criteria;
• Active cardiac disease, defined as one or more of the following:
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• Myocardial infarction less than 6 months from enrollment in the study;
• History of arrhythmias requiring medication or severe clinical symptoms;
• Uncontrolled or symptomatic congestive heart failure (\> NYHA Grade 2);

Sponsors & Collaborators

• The Second Affiliated Hospital of Kunming Medical University: lead
• Department of Hematology, Oncology Center, Tianjin Union Medical Center of Nankai University: collaborator
• Department of Hematology, Handan Central Hospital: collaborator
• Department of Hematology, The Affiliated Tai'an City Central Hospital of Qingdao University: collaborator
• Department of Hematology, The First Affiliated Hospital of Guangxi Medical University: collaborator
• Department of Hematology, The Second Xiangya Hospital, Central South University: collaborator
• Department of Hematology, Guizhou Provincial People's Hospital: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Affiliated Hospital of Qinghai University: collaborator
• State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chines: collaborator

Study Sites (1)

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650106, China

RECRUITING

Related Publications (4)

• Mantzaris I, Goldfinger M, Uriel M, Shastri A, Shah N, Gritsman K, Kornblum NS, Shapiro L, Sica RA, Munoz A, Chambers N, Dhawan A, Verceles JA, Fehn K, Tirone B, Shah L, Clark S, Zhang C, Kim M, Cooper DL, Verma A, Konopleva M, Feldman EJ. Venetoclax plus daunorubicin and cytarabine for newly diagnosed acute myeloid leukemia: results of a phase 1b study. Blood. 2025 Apr 24;145(17):1870-1875. doi: 10.1182/blood.2024026700.

  PMID: 39919267 RESULT

• Suo X, Fang Z, Wang D, Zhao L, Liu J, Li H, Ma X, Zhang C, Zhao X, Shi R, Wu Y, Jiao Z, Song J, Zhang L, Li L, Zhang S, Lu X, Yuan L, Gao S, Zhang J, Liu K, Zhao X, Bai G, Mi Y. Venetoclax combined with daunorubicin and cytarabine (2 + 6) in acute myeloid leukemia: Updated results of a phase II trial. Hematol Oncol. 2024 Jul;42(4):e3296. doi: 10.1002/hon.3296. No abstract available.

  PMID: 39041653 RESULT

• Mei M, Aldoss I, Marcucci G, Pullarkat V. Hypomethylating agents in combination with venetoclax for acute myeloid leukemia: Update on clinical trial data and practical considerations for use. Am J Hematol. 2019 Mar;94(3):358-362. doi: 10.1002/ajh.25369. Epub 2018 Dec 13.

  PMID: 30499168 RESULT

• Del Poeta G, Venditti A, Del Principe MI, Maurillo L, Buccisano F, Tamburini A, Cox MC, Franchi A, Bruno A, Mazzone C, Panetta P, Suppo G, Masi M, Amadori S. Amount of spontaneous apoptosis detected by Bax/Bcl-2 ratio predicts outcome in acute myeloid leukemia (AML). Blood. 2003 Mar 15;101(6):2125-31. doi: 10.1182/blood-2002-06-1714. Epub 2002 Nov 7.

  PMID: 12424199 RESULT

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

ZePing Zhou

CONTACT

+8618788571605; zhouzeping@kmmu.edu.cn

Yaxian Tan

CONTACT

+8618208821198; 353964619@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: July 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

CN (1)