Global Trial in APG2575 for Patients With CLL/SLL
This global study is for people aged 18 and over who have Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL) and have already been treated with a type of medication called a BTK inhibitor for at least 12 months. The study wants to see if adding a new drug, lisaftoclax, to their current BTK inhibitor treatment is more effective and safe than continuing with the BTK inhibitor alone. About 440 patients will take part, with half receiving the new combination treatment and the other half continuing with their BTK inhibitor. This is a Phase 3 study, which means it's usually one of the last steps before a drug might be approved for wider use. The aim is to find out if this new combination could be a better treatment option for patients with CLL/SLL.
At a glance
What is this study about?
This study is exploring a new treatment approach for people living with Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL). These are types of slow-growing blood cancers. Many people with CLL/SLL are treated with medications called BTK inhibitors, which have been very helpful in managing the condition. This particular study is for patients who have already been taking a BTK inhibitor for at least a year.
The main goal of this research is to see if adding a new drug called lisaftoclax to the existing BTK inhibitor treatment works better and is safe, compared to just continuing with the BTK inhibitor on its own. Researchers want to understand if this new combination could offer a more effective way to control the cancer for patients who are already on BTK inhibitors. The study is designed to gather important information that could potentially lead to a new treatment option for people with CLL/SLL.
About 440 people will be involved in this study. Patients who are suitable will be randomly put into one of two groups: one group will receive the new drug lisaftoclax alongside their BTK inhibitor, and the other group will continue with their BTK inhibitor as usual. Neither you nor the study staff will choose which group you are in; it's decided by chance, like flipping a coin. This helps make sure the results are fair and reliable. By comparing the two groups, the researchers can determine if the new combination treatment has advantages.
Key takeaways
- Tests a new drug (lisaftoclax) for CLL/SLL patients already on BTK inhibitors.
- Compares adding lisaftoclax to BTK inhibitor vs. BTK inhibitor alone.
- For adults aged 18 and over, who have received BTK inhibitors for at least 12 months.
- Involves regular clinic visits and health monitoring.
- Participation is voluntary, and you can withdraw at any time.
- Aims to find a potentially better treatment option for CLL/SLL.
Who may be eligible?
To be considered for this study, you must be at least 18 years old and have a confirmed diagnosis of CLL or SLL. A key requirement is that you must have already been receiving a BTK inhibitor medication as your only treatment for at least 12 months before joining the study.
Your general health also needs to be good enough to take part. This means your doctors will check your blood counts, like your white blood cells and platelets, to make sure they are at a healthy level. They will also check how well your kidneys and liver are working through blood tests. Your overall physical ability, often measured by something called an ECOG score, should be within certain limits.
Before joining, you’ll need to be able to understand and sign a consent form, showing you agree to take part and follow the study's plan, including attending all appointments and following instructions. The study team will review all your medical information carefully to see if you meet all the necessary requirements.
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.
- Are you 18 years old or older?
- Do you have a diagnosis of CLL or SLL?
- Have you been taking a BTK inhibitor medication for at least 12 months?
- Do you feel generally well enough to participate in a study?
- Are your kidney and liver function tests, and blood counts, generally within a healthy range?
- Are you able to attend all required study appointments?
What does participation involve?
If you decide to join this study, you'll be randomly assigned to one of two groups: either you'll take lisaftoclax in combination with your current BTK inhibitor, or you'll continue with your BTK inhibitor alone. You will visit the study clinic regularly for check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. These visits will be spread out over a period of time, and the exact schedule will be explained to you before you start.
During your participation, you will take the study medication as directed by the research team. This will involve either adding the new drug lisaftoclax to your existing BTK inhibitor or continuing with your BTK inhibitor. The study team will closely monitor for any side effects and ensure your safety throughout the process. After your main treatment period, there will be follow-up appointments to track your long-term health and the effects of the treatment. The total duration of your participation, including follow-up, will be clearly explained by the study team.
Potential risks and benefits
Locations (135)
- Ascentage Investigative SiteCity onlyTuscon, United States· Recruiting
- Ascentage Investigative SiteVerified postcodeAnaheim, United States· Recruiting
- Ascentage Investigative SiteVerified postcodeJacksonville, United States· Recruiting
- Ascentage Investigative SiteVerified postcodeMiami Beach, United States· Recruiting
- Ascentage Investigative SiteVerified postcodePeoria, United States· Recruiting
- Ascentage Investigative SiteVerified postcodeBoston, United States· Recruiting
- Ascentage Investigative SiteVerified postcodeAnn Arbor, United States· Recruiting
- Ascentage Investigative SiteVerified postcodeGreenville, United States· Recruiting
- Ascentage Investigative SiteVerified postcodeHouston, United States· Recruiting
- Ascentage Investigative SiteVerified postcodeKingswood, United States· Recruiting
- Ascentage Investigative SiteVerified postcodeRichmond, United States· Recruiting
- Ascentage Investigative SiteVerified postcodeGosford, Australia· Completed
Common questions
What is CLL/SLL?
CLL (Chronic Lymphocytic Leukaemia) and SLL (Small Lymphocytic Lymphoma) are slow-growing cancers that affect white blood cells called lymphocytes. They are very similar, differing mainly in where the cancer cells are found.
What is a BTK inhibitor?
BTK inhibitors are a type of medicine used to treat CLL/SLL. They work by blocking a protein called BTK inside cancer cells, which helps slow down the growth and spread of the cancer.
What is lisaftoclax?
Lisaftoclax is a new experimental drug being tested in this study. It works differently from BTK inhibitors and is being investigated to see if adding it to BTK inhibitor treatment can improve outcomes for patients.
Will I know which treatment group I'm in?
Yes, this is an 'open-label' study, which means both you and the study team will know whether you are taking lisaftoclax plus a BTK inhibitor, or just the BTK inhibitor.
Can I continue my regular medications during the study?
The study team will review all your current medications to ensure they don't interfere with the study drugs. Some adjustments might be needed, which will be discussed with you.
How to find out more
Shanthi Marur, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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