This clinical trial is focused on studying two diseases: Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome with Excess Blasts-2 (MDS-EB2). These are types of blood cancers that affect the bone marrow and blood cells. The study is testing a treatment that includes a medication called Venetoclax, which is taken as a film-coated tablet. Venetoclax is being tested in combination with other chemotherapy drugs, including Etoposide, Daunorubicin, Mitoxantrone, and Cytarabine, which are given through an intravenous infusion. The purpose of the study is to see if adding Venetoclax to the standard chemotherapy treatment can help improve the outcomes for patients with these conditions.
Participants in the study will receive either Venetoclax or a placebo, along with the standard chemotherapy drugs. The study will follow a specific schedule where patients will receive treatment over several weeks, with breaks in between to allow the body to recover. The study aims to determine if the treatment can prolong the time patients remain free from events like treatment failure, relapse, or the need for new therapy. The study will also look at overall survival rates, the rate of complete remission, and the quality of life of the participants.
The trial is designed to gather information over several years, with the estimated end date in 2028. Participants will be closely monitored throughout the study to assess the effectiveness and safety of the treatment. The study will help researchers understand if Venetoclax, when added to standard chemotherapy, can provide better outcomes for patients with newly diagnosed AML or MDS-EB2.
1joining the study
Upon joining the study, you will be randomly assigned to receive either the study medication venetoclax or a placebo. This is to compare the effects of the medication with no active treatment.
2induction therapy
During the induction phase, you will receive a combination of medications to treat your condition. This includes etoposide administered intravenously, daunorubicin administered intravenously, and cytarabine administered intravenously.
You will also take venetoclax orally if you are in the treatment group. The exact dosage and frequency will be determined by the study team based on your specific needs.
3consolidation therapy
After the induction phase, you will enter the consolidation phase. This phase aims to eliminate any remaining cancer cells and prevent relapse.
You will continue to receive venetoclax orally if you are in the treatment group, along with other medications as determined by the study protocol.
4follow-up
Throughout the study, regular follow-up visits will be scheduled to monitor your health and the effects of the treatment.
These visits will include physical examinations, blood tests, and other assessments as needed to ensure your safety and evaluate the treatment’s effectiveness.
5end of study
The study is expected to conclude by June 2028. At the end of the study, you will have a final evaluation to assess your overall health and the outcomes of the treatment.
You will be informed about the results of the study and any further steps that may be necessary for your care.
Who Can Join the Study?
Patients must have a new diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome with excess blasts-2 (MDS-EB2).
Patients must be at least 18 years old, with no upper age limit.
Patients must be eligible for intensive chemotherapy.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. This is a scale used to assess how a patient’s disease is progressing and how the disease affects their daily living abilities.
Patients must have adequate kidney function, shown by a serum creatinine level that is no more than twice the normal limit or a creatinine clearance greater than 40 mL/min. Creatinine is a waste product in the blood that comes from muscle activity, and its clearance is a measure of kidney function.
Patients must have adequate liver function, shown by:
Serum total bilirubin no more than 2.5 times the normal limit, unless due to a specific condition like Gilbert’s disease or leukemia involvement.
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) levels no more than 3 times the normal limit, unless due to leukemia involvement.
Patients must not have had prior chemotherapy for AML, except for hydroxyurea for up to 14 days during the diagnostic phase to control high white blood cell counts. Previous treatments for MDS with erythroid stimulating agents (ESA) or hypomethylating agents (HMAs) must have been stopped at least four weeks before starting the study treatment.
Patients must not have taken any strong or moderate CYP3A inducers 7 days before starting the study treatment. CYP3A inducers are substances that can increase the activity of certain liver enzymes, affecting how drugs are processed in the body.
Female patients must either be unable to have children or agree to use highly effective birth control methods during the study and for 27 weeks after the last dose of the study drug. They must also not be breastfeeding or donating eggs during this time.
Male patients must use a latex condom during sexual contact with women who can have children, even if they have had a vasectomy, and agree not to father a child during the study and for 27 weeks after the last dose of the study drug. They must also not donate sperm during this time.
Patients must be able to understand and willing to sign an informed consent form.
Who Cannot Join the Study?
Patients with a history of other types of cancer, except for those who have been cancer-free for at least 5 years.
Patients who have had a stem cell transplant in the past.
Patients with active infections that are not controlled with treatment.
Patients with severe heart problems.
Patients with severe liver problems.
Patients with severe kidney problems.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial.
Patients who have had an allergic reaction to any of the study medications.
Patients with a history of certain blood disorders.
Venetoclax is a medication used in this clinical trial to treat patients with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome with excess blasts. It works by helping to kill cancer cells. Venetoclax is taken in combination with other chemotherapy treatments to see if it can help patients live longer without the disease getting worse.
Acute myeloid leukemia – Acute myeloid leukemia is a type of cancer that starts in the blood-forming cells of the bone marrow. It progresses rapidly, leading to the accumulation of immature white blood cells called myeloblasts. These cells crowd out normal blood cells, causing symptoms like fatigue, frequent infections, and easy bruising or bleeding. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The rapid progression requires prompt medical attention to manage the symptoms and complications.
Myelodysplastic Syndrome With Excess Blasts-2 – Myelodysplastic Syndrome With Excess Blasts-2 is a disorder characterized by the production of poorly formed or dysfunctional blood cells in the bone marrow. It is marked by an increased number of immature blood cells, known as blasts, which do not mature properly. This condition can lead to anemia, infections, and bleeding due to the lack of healthy blood cells. Over time, the number of blasts may increase, potentially transforming into acute myeloid leukemia. The progression involves a gradual worsening of blood cell production and function. Regular monitoring is essential to track changes in blood cell counts and blast levels.
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