Daunorubicin + Cytarabine + Venetoclax in de Novo AML

NCT06697327 | Enrolling By Invitation DMC

• 1 other identifier: PJ 2023-09-19
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Myeloid, Acute; Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Defined as the proportion of patients achieving 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) occurring at the end of 2 cycles of treatment. Will be estimated along with the 95% credible interval. Patients who drop out of the study before completing 2 cycles and have been treated will be censored for the primary endpoint analysis.

  End of cycle 2 (each cycle is 14 days)

Secondary Outcomes (4)

• Overall survival (OS)

  1-Year Follow-up

• Event-free survival (EFS)

  1-Year Follow-up

• duration of remission (DOR)

  1-Year Follow-up

• Incidence of adverse events

  1-Year Follow-up

Study Arms (2)

Treatment(Daunorubicin, Cytarabine, Ventoclax)

EXPERIMENTAL

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

Drug: (Daunorubicin, Cytarabine, Venetoclax)

Control(Daunorubicin, Cytarabine)

ACTIVE COMPARATOR

Control(Daunorubicin, Cytarabine) See Detailed Description.

Drug: (Daunorubicin, Cytarabine)

Interventions

(Daunorubicin, Cytarabine, Venetoclax) 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

Treatment(Daunorubicin, Cytarabine, Ventoclax)

(Daunorubicin, Cytarabine) 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

Control(Daunorubicin, Cytarabine)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Medical University: lead
• The First Affiliated Hospital of Anhui Medical University: collaborator

Study Sites (1)

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

Hefei, Anhui, 230022, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Daunorubicin; Cytarabine; venetoclax

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• ZhangBiao Long, Doctor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 20, 2024
• Study Start: February 1, 2025
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)