Study on Ivosidenib, Azacitidine, and Venetoclax for Adults with Newly Diagnosed IDH1-Mutated Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy
This clinical trial is focused on studying a type of blood cancer called Acute Myeloid Leukemia (AML), specifically in patients who have a certain genetic change known as the IDH1 mutation. The study is looking at how effective a combination of medications is in treating this condition. The medications being tested include venetoclax, which is also known by its code names ABT-199 and GDC-0199, ivosidenib, and azacitidine. These drugs are being used together to see if they can help patients live longer without the disease getting worse.
The purpose of the study is to determine if adding venetoclax to the treatment with ivosidenib and azacitidine can improve outcomes for patients with newly diagnosed IDH1-mutated AML who are not eligible for intensive chemotherapy. The study will involve taking these medications in the form of film-coated tablets or injections over a period of time. Some patients will receive a placebo, which looks like the real medication but does not contain the active drug, to compare the effects.
Participants in the study will be monitored to see how their condition responds to the treatment. The study will track how long patients remain free of disease progression, as well as other factors like overall survival and quality of life. The trial aims to provide valuable information on whether this combination of medications can offer a new treatment option for patients with this specific type of AML.
1beginning of treatment
Upon joining the study, you will start your treatment with a combination of medications. These include ivosidenib, azacitidine, and possibly venetoclax. The specific combination will depend on the group you are assigned to.
The ivosidenib is taken orally in the form of a 250 mg film-coated tablet. The azacitidine is administered subcutaneously, which means it is injected under the skin. The venetoclax is also taken orally, with available dosages of 10 mg, 50 mg, and 100 mg film-coated tablets.
2medication schedule
The treatment involves taking the medications daily. The exact dosage and frequency will be determined by the study team based on your specific needs and the group you are assigned to.
The duration of the treatment will be specified by the study team, and it is important to follow the schedule as instructed to ensure the effectiveness of the treatment.
3monitoring and assessments
Throughout the study, regular monitoring and assessments will be conducted to evaluate your response to the treatment. This includes blood tests and other necessary evaluations to track your progress.
These assessments are crucial to ensure your safety and to determine the effectiveness of the treatment regimen.
4end of treatment
The study aims to assess the treatment’s impact on event-free survival, which means the time you remain free from certain complications or events related to your condition.
The study is expected to continue until 2032, but your participation will be for a specific duration as determined by the study protocol and your health status.
Who Can Join the Study?
Patient must have newly diagnosed IDH1-mutated Acute Myeloid Leukemia (AML) or IDH1-mutated MDS/AML. Patients with both IDH1 and IDH2 mutations are also eligible.
Confirmation of the IDH1 mutation must be done in a specialized laboratory.
Patient must be 18 years or older, with no upper age limit.
Patient is not eligible for intensive chemotherapy due to age (75 years or older) or specific health conditions, such as heart problems, lung issues, or other serious health concerns.
Patient must have a life expectancy of at least 12 weeks, as determined by the doctor.
Patient must have a white blood cell count of less than 25 x 109/L.
Patient must have adequate kidney function, shown by specific blood test results.
Patient must have adequate liver function, shown by specific blood test results.
Female patients must not be able to become pregnant or must agree to avoid pregnancy during the study and for 6 months after the last dose of the study drug. They must also agree not to breastfeed during the study and for a specified time after the study ends.
Male patients must agree not to father a child during the study and for 6 months after the last dose of the study drug. They must also agree not to donate sperm during this time.
Patient must be able to understand and willing to sign a consent form to participate in the study.
Who Cannot Join the Study?
Patients who have received any other treatment for Acute Myeloid Leukemia (AML) before the study cannot participate. Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow.
Patients with other types of cancer that require treatment are not eligible.
Patients with severe heart problems cannot join the study.
Patients with uncontrolled infections are not allowed to participate.
Pregnant or breastfeeding women cannot take part in the study.
Patients who have had a stem cell transplant in the past are excluded.
Patients with a history of certain other medical conditions that might interfere with the study are not eligible.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.
Ivosidenib is a medication used in this trial to treat a specific type of blood cancer called acute myeloid leukemia (AML) that has a mutation in the IDH1 gene. This medication works by blocking the activity of the mutated IDH1 protein, which can help stop the growth of cancer cells and potentially lead to their death. It is used in patients who are not able to undergo intensive chemotherapy.
Azacitidine is another medication used in this trial. It is a type of drug known as a hypomethylating agent. Azacitidine works by interfering with the growth of cancer cells, which can help slow down or stop the progression of the disease. It is often used to treat certain types of blood cancers, including AML, and is particularly useful for patients who cannot tolerate more aggressive treatments.
Venetoclax is included in this trial to see if it can improve outcomes when combined with ivosidenib and azacitidine. Venetoclax works by targeting a specific protein in cancer cells that helps them survive. By blocking this protein, venetoclax can help to kill cancer cells and may enhance the effectiveness of other treatments in the trial. It is used for patients with AML who are not eligible for intensive chemotherapy.
Acute Myeloid Leukemia (AML) – Acute Myeloid Leukemia is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. As the disease progresses, it can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. AML can develop quickly, requiring prompt medical attention. The disease is often associated with genetic mutations, such as IDH1 mutations, which can influence its behavior and progression. AML is more common in adults and can vary in its presentation and severity.
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