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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
* 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
* 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
Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road
Hefei, Anhui, China
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.
Time frame: End of cycle 2 (each cycle is 14 days)
Overall survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause. Patients who are alive at the time of the last follow-up will be censored at the date of last contact. OS will be estimated using Kaplan-Meier methods, with median survival and 95% confidence intervals reported for each treatment group.
Time frame: 1-Year Follow-up
Event-free survival (EFS)
Event-Free Survival (EFS) is defined as the time from randomization to the first occurrence of disease progression, relapse, new cancer occurrence, or death from any cause. Patients who remain event-free at the last follow-up will be censored at the date of last contact. EFS will be estimated using Kaplan-Meier methods, with median EFS and 95% confidence intervals reported for each treatment group.
Time frame: 1-Year Follow-up
duration of remission (DOR)
Duration of Remission (DOR) is defined as the time from the first documentation of complete or partial remission until disease progression or relapse. Patients who remain in remission at the last follow-up will be censored at the date of last contact. DOR will be estimated using Kaplan-Meier methods, with median DOR and 95% confidence intervals reported for each treatment group.
Time frame: 1-Year Follow-up
Incidence of adverse events
Incidence of adverse events will be defined by Grade 3-4 clinical adverse events (AEs), incidence of laboratory abnormalities, and treatment-related mortality (TRM).
Time frame: 1-Year Follow-up
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