Daunorubicin, Cytarabine, and Venetoclax for Acute Myeloid Leukemia
(Daunorubicin, Cytarabine, Venetoclax)
+ (Daunorubicin, Cytarabine)
Hematologic Diseases+4
+ Hemic and Lymphatic Diseases
+ Leukemia
Treatment Study
Summary
Study start date: February 1, 2025
Actual date on which the first participant was enrolled.This clinical trial is investigating a new treatment approach for patients who have just been diagnosed with Acute Myeloid Leukemia (AML). The study compares two treatment regimens: a standard combination of the drugs Daunorubicin and Cytarabine, and an experimental regimen that adds a third drug, Venetoclax, to the mix. The goal is to see if the addition of Venetoclax can improve the chances of achieving remission while potentially causing fewer side effects. This research is important because it could lead to better outcomes for people with AML, a serious type of blood cancer. The study involves two groups of participants. One group receives the standard treatment of Daunorubicin and Cytarabine, while the other group receives a slightly altered version of this treatment with added Venetoclax. Participants in the experimental group take Daunorubicin for three days, Cytarabine for five days, and Venetoclax for up to fourteen days. This study measures various aspects of treatment success, such as complete remission rates and long-term survival. It also monitors safety by tracking any severe side effects or issues that arise during the treatment. The aim is to find a balance between effectiveness and safety in treating AML.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.94 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 59 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria:(All of the following criteria must be met.) 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:(Any of the following criteria will exclude the patient from participation) * 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road
Hefei, ChinaOpen Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road in Google Maps