Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).
This study, called GLORA-4, is investigating a new treatment for higher-risk myelodysplastic syndrome (MDS). MDS is a condition where the bone marrow, which makes blood cells, doesn't work properly, leading to low numbers of healthy blood cells. In higher-risk MDS, there's a greater chance of it turning into leukaemia. Researchers want to see if adding a new drug called lisaftoclax to a common treatment, azacitidine, can help people live longer. Half the patients in the study will receive lisaftoclax plus azacitidine, while the other half will get a dummy drug (placebo) plus azacitidine. This is a large study involving many hospitals around the world, comparing these two approaches to find the best way forward.
At a glance
What is this study about?
This study, known as GLORA-4, is focused on a specific type of blood disorder called myelodysplastic syndrome (MDS). In people with MDS, the bone marrow – the spongy tissue inside your bones that makes blood cells – doesn't produce enough healthy blood cells. This can lead to issues like anaemia (feeling tired), infections, or bleeding problems. 'Higher-risk' MDS means there's a greater chance of the condition getting worse or developing into a more serious type of blood cancer called leukaemia.
Doctors are always looking for better ways to treat higher-risk MDS. This study is testing a new drug called lisaftoclax (also known as APG-2575). It's being given alongside azacitidine, which is a standard treatment for MDS. The main goal is to see if combining lisaftoclax with azacitidine helps people with newly diagnosed higher-risk MDS live longer compared to just having azacitidine with a dummy drug (placebo).
This is a 'Phase 3' study, which means it's a large, important trial that compares a new treatment with a standard one to see if it's better. It's being run in many different hospitals globally and involves people being randomly assigned to one of two treatment groups. Neither the patient nor their doctor will know which treatment they are receiving, which helps ensure the results are fair and unbiased. The findings from this study could potentially help shape future treatments for higher-risk MDS.
Key takeaways
- This study is testing a new combination treatment for a serious blood condition called higher-risk MDS.
- It aims to see if adding the drug lisaftoclax to azacitidine helps people live longer.
- Half of the participants will receive the new drug combination, and the other half will receive azacitidine with a dummy drug.
- Participation involves regular hospital visits for treatment and health checks.
- You won't know which treatment you are receiving until the study concludes.
- You can withdraw from the study at any point without impacting your care.
Who may be eligible?
To join this study, you would need to meet certain conditions. You must have been recently diagnosed with higher-risk myelodysplastic syndrome (MDS). You'd also need to be generally well enough to take part, meaning you can manage your daily activities without too much difficulty, and your body's main organs (like your liver and kidneys) are working well enough. You should expect to live for at least three more months to allow enough time for the study to gather information about the treatment.
There are also some reasons why you might not be able to join. For example, if you've had other cancers recently or if you've had a stem cell transplant before, you wouldn't be eligible. You also can't be taking certain medications that might interfere with the study drugs. The study team will check all these details carefully to make sure the study is safe for you and that the results will be clear.
If you are a woman who could become pregnant, you would need a negative pregnancy test before starting treatment and agree to use effective contraception during the study and for six months afterwards. Everyone joining the study must be able to understand what's involved and sign a consent form, agreeing to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Have I been recently diagnosed with higher-risk MDS?
- Am I generally well enough for daily activities without too much help?
- Are my main organs (like liver, kidneys) working reasonably well?
- Have I not had a stem cell transplant before?
- If I am a woman who could get pregnant, am I willing to use effective contraception?
- Am I able to understand and sign the consent form?
What does participation involve?
If you decide to join this study, you will receive either the new drug (lisaftoclax) along with azacitidine, or a dummy drug (placebo) along with azacitidine. The azacitidine is given as an injection. You and your doctor won't know which combination you are getting until after the study is complete. You will have regular visits to the hospital or clinic for your treatment and check-ups.
During these visits, the study team will carry out various assessments. This includes physical examinations, blood tests, and other tests to see how you are responding to the treatment and to monitor your health. You'll need to answer questions about how you are feeling and any side effects you might be experiencing. The study will continue as long as the treatment is helping you and you are tolerating it well. After you stop taking the study medication, there will be follow-up appointments to track your health over time. The total duration of your involvement could be several months or longer, depending on how your treatment progresses.
Potential risks and benefits
Locations (155)
- Ascentage Investigative SiteVerified postcodeBirmingham, United States· Not yet recruiting
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- Ascentage Investigative SiteVerified postcodeChicago, United States· Recruiting
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- AscentageVerified postcodeIowa City, United States· Not yet recruiting
- Ascentage Investigative SiteVerified postcodeLouisville, United States· Recruiting
- Ascentage Investigative SiteVerified postcodeBaltimore, United States· Recruiting
Common questions
What is 'higher-risk Myelodysplastic Syndrome'?
It's a condition where your bone marrow doesn't make enough healthy blood cells, and there's a higher chance it could turn into a type of leukaemia.
What are the drugs being tested?
The study is combining a new drug called lisaftoclax with a standard treatment called azacitidine. Some people will get a dummy drug instead of lisaftoclax.
What does 'randomised, double-blind' mean?
It means you're randomly assigned to a treatment group, and neither you nor your doctor will know if you're getting the new drug or the dummy drug, to keep the results fair.
How long will I be in the study?
The time you spend in the study can vary. You'll continue treatment as long as it's helping and you're tolerating it. There will also be follow-up appointments after treatment ends.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, and it won't affect your future medical care.
How to find out more
Yifan Zhai, M.D., Ph.D.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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