This clinical trial is focused on studying a condition known as Higher Risk Myelodysplastic Syndrome (HR-MDS), which is a type of blood disorder where the bone marrow does not produce enough healthy blood cells. The study will evaluate the effectiveness of a new treatment combination involving two medications: Lisaftoclax (also known by its code name APG-2575) and Azacitidine. These medications will be compared to a combination of a placebo and Azacitidine to see which is more effective in treating HR-MDS.
The purpose of the study is to assess how well the combination of Lisaftoclax and Azacitidine works in patients who have been newly diagnosed with HR-MDS. Participants in the study will receive either the combination of Lisaftoclax and Azacitidine or a placebo with Azacitidine. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This helps ensure that the results are unbiased and reliable.
Throughout the study, participants will be monitored regularly to track their response to the treatment and any side effects they may experience. The study aims to provide valuable information on the potential benefits and safety of using Lisaftoclax in combination with Azacitidine for treating HR-MDS, which could lead to improved treatment options for patients with this condition in the future.
1joining the study
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the combination of lisaftoclax and azacitidine, while the other group will receive a placebo (a substance with no active medication) and azacitidine. This process is double-blind, meaning neither you nor the study team will know which group you are in.
2medication administration
If you are in the group receiving lisaftoclax, you will take it in the form of a tablet by mouth. The dosage and frequency will be determined by the study team based on your specific needs.
All participants will receive azacitidine as a suspension for injection. This can be administered through a vein (intravenous), under the skin (subcutaneous), or into a muscle (intramuscular). The study team will decide the best method for you.
3treatment duration
The treatment will continue for a period specified by the study team, which may vary depending on your response to the medication and any side effects you experience. Regular assessments will be conducted to monitor your health and the effectiveness of the treatment.
4follow-up visits
You will have scheduled follow-up visits with the study team. During these visits, your health will be monitored, and any side effects or changes in your condition will be assessed. These visits are crucial for ensuring your safety and the success of the study.
5end of study participation
At the end of your participation in the study, a final assessment will be conducted. This will include a review of your overall health and any changes that have occurred during the study. You will also have the opportunity to discuss your experience and any concerns with the study team.
Who Can Join the Study?
Must be 18 years old or older.
Must have a newly diagnosed higher risk myelodysplastic syndrome according to the 2022 World Health Organization classification.
Must have an ECOG performance status of 2 or less. (This is a scale used to assess how a disease affects a patient’s daily living abilities, with 0 being fully active and 5 being deceased.)
Must have a life expectancy of at least 3 months.
Must be able to take oral medication.
Must have adequate organ function, which includes:
Creatinine clearance of at least 30 ml/min. (This measures how well the kidneys are working.)
Total bilirubin less than 1.5 times the upper limit of normal, except in certain conditions like Gilbert’s syndrome or due to regular blood transfusions.
AST and ALT levels less than or equal to 2.5 times the upper limit of normal. (These are liver enzymes, and their levels indicate liver health.)
Women of childbearing potential must have a negative pregnancy test before starting the study. They and their partners must agree to use effective contraception during the study and for at least 6 months after the last dose.
Must be able to understand and sign a written informed consent form before any study procedures are done.
Must be willing to participate in the study and able to complete study procedures and follow-up examinations.
Who Cannot Join the Study?
Patients with any other type of cancer cannot participate.
Patients who have had a heart attack in the last 6 months are not eligible.
Patients with uncontrolled high blood pressure cannot join the study. Uncontrolled high blood pressure means that even with medication, the blood pressure is not within a safe range.
Patients with severe liver disease are excluded. Severe liver disease refers to serious conditions affecting the liver’s ability to function properly.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are currently participating in another clinical trial are not eligible.
Patients with a known allergy to the study medication cannot participate.
Patients with a history of drug or alcohol abuse in the past year are excluded.
Patients with any serious infection that requires treatment with antibiotics are not eligible.
Patients with a history of certain mental health conditions, such as severe depression or anxiety, cannot participate.
Lisaftoclax is a medication being studied for its potential to help treat a condition called higher risk myelodysplastic syndrome, which is a type of blood disorder. In this trial, Lisaftoclax is being tested to see if it can work together with another medication to improve treatment outcomes for patients who have been newly diagnosed with this condition.
Azacitidine is a medication that is already used to treat certain blood disorders, including myelodysplastic syndrome. It works by helping to restore normal growth and function to blood cells. In this trial, Azacitidine is being used in combination with Lisaftoclax to see if the two medications together can provide better results for patients with higher risk myelodysplastic syndrome.
Newly Diagnosed Higher Risk Myelodysplastic Syndrome – Myelodysplastic syndrome (MDS) is a group of disorders caused by poorly formed or dysfunctional blood cells. In higher risk MDS, the bone marrow produces immature blood cells that do not mature properly, leading to a shortage of healthy blood cells. This condition can result in symptoms such as fatigue, infections, and easy bruising or bleeding due to low blood cell counts. Over time, the disease can progress as the bone marrow becomes less effective at producing healthy cells. The condition is considered higher risk when there is a greater likelihood of progression to acute myeloid leukemia. The progression of the disease involves increasing bone marrow failure and worsening blood cell deficiencies.
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