Daunorubicin + Cytarabine + Venetoclax in de Novo AML

NCT ID: NCT06697327

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-08-01

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVE:

1. To evaluate the efficacy of the regimen, as defined by complete remission (CR), complete remission with partial hematologic recovery (CRh), complete remission with incomplete hematologic recovery (CRi), morphological leukemia-free state (MLFS), and partial remission (PR).

SECONDARY OBJECTIVES:

1. To evaluate the long-term effectiveness and durability of the treatment of the regimen, as defined by 1-year overall survival (OS), 1-year event-free survival (EFS), and duration of remission (DOR).

2. To evaluate the safety of the regimen, as defined by Grade 3-4 clinical adverse events (AEs), incidence of laboratory abnormalities, and treatment-related mortality (TRM).

OUTLINE:

• The regimen for the control group includes:(Daunorubicin, Cytarabine)

• Daunorubicin: 60 mg/(m²·d) on days 1 to 3
• Cytarabine: 100 mg/(m²·d) on days 1 to 7
• The experimental group's "DAV" regimen includes: (Daunorubicin, Cytarabine, Venetoclax)

• Daunorubicin: 40 mg/(m²·d) on days 1 to 3
• Cytarabine: 100 mg/(m²·d) on days 1 to 5
• Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg from days 3 to 14
• The "DAV" regimen is designed to shorten the duration of induction chemotherapy while extending the application period of venetoclax, aiming to improve efficacy while reducing adverse effects.

Conditions

Leukemia, Myeloid, Acute; Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment(Daunorubicin, Cytarabine, Ventoclax)

Treatment(Daunorubicin, Cytarabine, Ventoclax) See Detailed Description.

Group Type: EXPERIMENTAL

(Daunorubicin, Cytarabine, Venetoclax)

Intervention Type: DRUG

• Drugs：Daunorubicin

• Dosage: 40 mg/(m²·d) on days 1 to 3
• Other names: Cerubidine, Daunomycin, Rubidomycin
• Drugs：Cytarabine

• Dosage: 100 mg/(m²·d) on days 1 to 5
• Other names: Ara-C, Cytosine Arabinoside, Cytosar-U
• Drugs：Venetoclax

• Dosage: 100 mg on day 1, 200 mg on day 2, and 400 mg from days 3 to 14
• Other names: ABT-199, Venclexta, Venclyxto

Control(Daunorubicin, Cytarabine)

Control(Daunorubicin, Cytarabine) See Detailed Description.

Group Type: ACTIVE_COMPARATOR

(Daunorubicin, Cytarabine)

Intervention Type: DRUG

• Drugs：Daunorubicin

• Dosage: 60 mg/(m²·d) on days 1 to 3
• Other names: Cerubidine, Daunomycin, Rubidomycin
• Drugs：Cytarabine

• Dosage: 100 mg/(m²·d) on days 1 to 7
• Other names: Ara-C, Cytosine Arabinoside, Cytosar-U

Interventions

(Daunorubicin, Cytarabine, Venetoclax)

• Drugs：Daunorubicin

• Dosage: 40 mg/(m²·d) on days 1 to 3
• Other names: Cerubidine, Daunomycin, Rubidomycin
• Drugs：Cytarabine

• Dosage: 100 mg/(m²·d) on days 1 to 5
• Other names: Ara-C, Cytosine Arabinoside, Cytosar-U
• Drugs：Venetoclax

• Dosage: 100 mg on day 1, 200 mg on day 2, and 400 mg from days 3 to 14
• Other names: ABT-199, Venclexta, Venclyxto

Intervention Type: DRUG

(Daunorubicin, Cytarabine)

• Drugs：Daunorubicin

• Dosage: 60 mg/(m²·d) on days 1 to 3
• Other names: Cerubidine, Daunomycin, Rubidomycin
• Drugs：Cytarabine

• Dosage: 100 mg/(m²·d) on days 1 to 7
• Other names: Ara-C, Cytosine Arabinoside, Cytosar-U

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role: collaborator

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhangbiao Long

Vice director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ZhangBiao Long, Doctor

Role: STUDY_CHAIR

Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road

Locations

Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road

Hefei, Anhui, China

Countries

China

Other Identifiers

PJ 2023-09-19

Identifier Type: -

Identifier Source: org_study_id