A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
This research study is looking at a new drug called nemtabrutinib for people newly diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Participants will either receive nemtabrutinib or one of the standard treatments, ibrutinib or acalabrutinib, chosen by their doctor. The main goal is to find out if nemtabrutinib works at least as well as the standard treatments in shrinking the cancer. The researchers also want to see if nemtabrutinib can help patients live longer without their cancer getting worse compared to the current drugs. This is an important step in finding potentially better ways to treat these conditions.
At a glance
What is this study about?
This study, called BELLWAVE-011, is designed to test a new medicine named nemtabrutinib for people who have recently been diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and haven't started treatment yet. CLL and SLL are types of blood cancer that affect immune cells called lymphocytes. For people with these conditions, treatment might be needed if the disease is active and causing problems.
In this study, participants will be randomly assigned to receive either the new drug, nemtabrutinib, or one of two established treatments, ibrutinib or acalabrutinib. The doctors involved will decide which of the established treatments is most suitable for you if you're in that group. The main aim is to see how nemtabrutinib compares to these standard options. We want to know if it's just as effective, or perhaps even more effective, at reducing the cancer and preventing it from growing back.
The researchers will closely monitor how well the treatments work. They'll pay attention to how much the cancer shrinks, which is called the 'objective response rate'. They'll also look at how long people live without their cancer getting worse, known as 'progression-free survival'. This information will help us understand if nemtabrutinib could be a valuable new treatment option for people with CLL or SLL in the future.
Key takeaways
- This study compares a new drug (nemtabrutinib) against existing treatments for CLL/SLL.
- It's for people who haven't had treatment for their CLL/SLL before.
- Participants will be randomly assigned to one of the treatments.
- The aim is to see if nemtabrutinib is as good or better than current options.
- Regular monitoring and follow-up will be part of taking part.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that needs treatment. You should also be generally well enough to take part, meaning you can carry out most daily activities without too much difficulty. You need to be able to swallow tablets whole. If you have had hepatitis B or C, it must be inactive, and certain other conditions like serious heart problems or other active cancers would mean you can't join.
There are also some specific health checks the study team will carry out to make sure it's safe for you to take part. For example, if you have certain gastrointestinal issues that might stop the medicine from being absorbed properly, you wouldn't be able to join. Additionally, if your CLL/SLL has spread to your brain or spinal cord, or if you've had certain serious infections recently, you would not be eligible.
Importantly, you mustn't have had any medication for your CLL/SLL before joining this study. Also, if you're taking certain other medicines that might interfere with the study drugs, you might not be able to participate. This study is open to both men and women aged 18 and over.
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.
- I have been diagnosed with CLL or SLL that needs treatment.
- I have not received any prior treatment for my CLL or SLL.
- I am generally well and can swallow tablets.
- I am 18 years old or older.
- I do not have active hepatitis B or C, or serious heart problems.
- I am not currently taking certain medications that could interfere with the study drugs.
What does participation involve?
If you decide to take part in this study, you will first have a number of checks to make sure the study therapies are suitable and safe for you. If you meet all the criteria, you will then be randomly assigned to receive either the new drug, nemtabrutinib, or one of the standard treatments (ibrutinib or acalabrutinib). This means neither you nor your doctor can choose which treatment you receive; it's decided by chance, like flipping a coin.
The treatments are taken by mouth as tablets. You will have regular visits to the hospital for examinations, blood tests, and scans to monitor your health and how well the treatment is working. It's important to report any new symptoms or side effects you experience to the study team immediately. The exact number and frequency of visits will be explained by the study team, but they will be more frequent at the beginning and become less frequent over time. You will continue to take the study medication and attend follow-up appointments for as long as the treatment is helping and is safe for you, or until the study ends.
Potential risks and benefits
Locations (198)
- USA Mitchell Cancer Institute ( Site 0014)Verified postcodeMobile, United States· Recruiting
- Banner MD Anderson Cancer Center ( Site 0059)Verified postcodeGilbert, United States· Recruiting
- Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)Verified postcodePhoenix, United States· Recruiting
- Arizona Oncology Associates - NAHOA ( Site 8007)Verified postcodePrescott, United States· Completed
- Alta Bates Summit Medical Center ( Site 0004)Verified postcodeBerkeley, United States· Recruiting
- Moores Cancer Center ( Site 0003)Verified postcodeLa Jolla, United States· Recruiting
- Care Access - South Pasadena ( Site 0070)Verified postcodePasadena, United States· Recruiting
- Saint Joseph Hospital ( Site 0026)Verified postcodeDenver, United States· Recruiting
- Lutheran Medical Center ( Site 0027)Verified postcodeGolden, United States· Recruiting
- Intermountain Health St. Mary's Regional Hospital ( Site 0025)Verified postcodeGrand Junction, United States· Recruiting
- Eastern CT Hematology & Oncology Associates ( Site 0033)Verified postcodeNorwich, United States· Recruiting
- Clermont Oncology Center ( Site 0046)Verified postcodeClermont, United States· Recruiting
Common questions
What is Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)?
These are slow-growing cancers that affect a type of white blood cell called lymphocytes. They are closely related, with SLL affecting the lymph nodes and spleen, and CLL affecting the blood and bone marrow.
What is a 'Phase 3' study?
A Phase 3 study is a large study that compares a new treatment with existing standard treatments. It's done to confirm if the new treatment is safe and effective before it can be made widely available.
What does 'randomly assigned' mean?
This means that you will be put into one of the treatment groups by chance, like drawing numbers from a hat. Neither you nor your doctor will choose which treatment you receive.
Will I know which treatment I am receiving?
The study team will tell you if this is an 'open-label' study (where you know your treatment) or 'blinded' (where you don't know). The detailed study information will explain this.
Who is paying for this study?
This study is sponsored by a pharmaceutical company called Merck Sharp & Dohme LLC, which is developing the new medication.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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