This clinical trial is focused on studying a type of blood cancer called Acute Myeloid Leukemia (AML). The study is specifically for patients who have a newly diagnosed form of AML with certain genetic changes, known as NPM1 mutations or KMT2A rearrangements, and who are not eligible for intensive chemotherapy. The trial will investigate the effects of adding a new medication called Revumenib to a treatment regimen that includes two other drugs, Azacitidine and Venetoclax. Revumenib is also known by its code name, SNDX-5613.
The purpose of the study is to determine if this combination of medications can help improve the overall survival of patients with this specific type of AML. Participants in the study will receive either the combination of Revumenib, Azacitidine, and Venetoclax or a placebo along with Azacitidine and Venetoclax. The study will last for a period of up to 76 weeks, during which the effects of the treatment will be monitored. The medications will be administered in the form of tablets taken orally, and Azacitidine will be given as an injection.
This trial aims to provide valuable information on whether the addition of Revumenib can enhance the effectiveness of the existing treatment for patients with these specific genetic changes in AML. The study will also look at various outcomes, such as the time it takes for the treatment to start working, the duration of the response, and the quality of life of the participants. The results will help in understanding the potential benefits and safety of this new treatment approach for patients with AML who cannot undergo intensive chemotherapy.
1introduction to the study
Upon joining the study, the patient will receive an overview of the trial’s purpose, which is to evaluate if adding revumenib to the treatment with azacitidine and venetoclax can improve survival in patients with a specific type of acute myeloid leukemia (AML).
The patient will be informed about the study’s duration and the expected end date in April 2031.
2treatment initiation
The patient will begin treatment with a combination of medications: revumenib, azacitidine, and venetoclax.
Revumenib is administered orally in tablet form. The dosage and frequency will be determined by the study protocol.
Azacitidine is given as a subcutaneous injection. The dosage and schedule will be specified by the study team.
Venetoclax is provided as film-coated tablets for oral use. The dosage and frequency will be outlined in the study protocol.
3monitoring and assessments
Throughout the study, the patient will undergo regular monitoring to assess the effectiveness of the treatment and any side effects.
Blood tests and other assessments will be conducted to evaluate the patient’s response to the treatment and to monitor overall health.
4completion of treatment cycle
The treatment cycle will continue as per the study protocol, with regular assessments to determine the patient’s response.
The patient will be informed about the duration of each treatment cycle and any necessary adjustments based on their response.
5end of study participation
Upon completion of the study or if the patient decides to withdraw, a final assessment will be conducted to evaluate the overall impact of the treatment.
The patient will receive information about any follow-up care or monitoring that may be required after the study ends.
Who Can Join the Study?
Patient must have newly diagnosed NPM1-mutated Acute Myeloid Leukemia (AML) or KMT2A-rearranged AML. This means the patient has a specific type of blood cancer identified by certain genetic changes.
Men must use a latex condom during any sexual contact with women who can become pregnant, even if they have had a vasectomy. They must also agree not to father a child while on therapy and for 6 months after the last study drug is given. Their female partners must use a highly effective birth control method.
Men must not donate sperm starting at the beginning of the study and for 6 months after the last study drug is given.
Patient must be able to understand and willing to sign an informed consent form, which is a document explaining the study and its risks.
Patient must have written informed consent approved by an ethics committee before any study-related procedures.
Confirmation of the NPM1 mutation or KMT2A rearrangement must be done in a central genetic 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 other health conditions, such as heart problems or lung issues.
Patient must have a life expectancy of at least 12 weeks, as assessed by the doctor.
Patient must have a white blood cell count of less than 25 x 109/L. A medication called hydroxyurea can be used to lower the white blood cell count if needed.
Patient must have adequate kidney function, shown by certain blood test results.
Patient must have adequate liver function, shown by certain blood test results.
Female patients must either be unable to become pregnant or agree to avoid pregnancy during the study and for 6 months after the last study drug is given. They must have a negative pregnancy test at the start of the study and use effective birth control if sexually active. They must also agree not to breastfeed or donate eggs during the study and for a specified time after.
Who Cannot Join the Study?
Patients who have already received treatment for their Acute Myeloid Leukemia (AML) cannot participate. AML is a type of cancer that affects the blood and bone marrow.
Patients who are eligible for intensive chemotherapy are not allowed to join. Intensive chemotherapy is a strong treatment that uses drugs to kill cancer cells.
Patients with other serious health conditions that might interfere with the study treatment are excluded. This means if you have another major illness, you might not be able to join.
Pregnant or breastfeeding women cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who have participated in another clinical trial within the last 30 days are not eligible. This is to avoid any interference from other treatments.
Patients with known allergies to the study drugs or their ingredients cannot join. This is to prevent any allergic reactions.
Patients with a history of certain heart conditions are excluded. This is to ensure the treatment does not affect heart health.
Patients who are unable to follow the study procedures or attend regular check-ups are not eligible. This is important for accurate monitoring and results.
Revumenib is an investigational medication being studied for its potential to treat certain types of acute myeloid leukemia (AML). It is being tested to see if it can help improve survival in patients who have specific genetic mutations and are not able to undergo intensive chemotherapy.
Azacitidine is a medication used to treat certain blood disorders and types of leukemia. It works by helping to restore normal growth of blood cells and reducing the number of abnormal cells in the blood.
Venetoclax is a medication used to treat certain types of leukemia. It works by targeting and blocking a protein that helps cancer cells survive, which may lead to the death of these cancer cells.
Acute Myeloid Leukemia (AML) – Acute Myeloid Leukemia is a type of cancer that starts in the blood-forming cells of the bone marrow. It progresses rapidly and affects the production of normal blood cells. In AML, the bone marrow produces abnormal myeloblasts, a type of white blood cell, red blood cells, or platelets. These abnormal cells can build up in the bone marrow and blood, crowding out healthy cells. This can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. AML is characterized by genetic mutations, such as NPM1 mutations, which can influence the disease’s behavior and response to treatment.
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