RecruitingPHASE3INTERVENTIONAL

A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).

This study, called BELLWAVE-010, is for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or hasn't responded to previous treatments. Researchers want to see if combining a new medicine, Nemtabrutinib, with Venetoclax is more effective and safer than a current standard treatment that uses Venetoclax and Rituximab. The main goal is to find out if the Nemtabrutinib combination can keep the cancer from getting worse for longer. This is a Phase 3 study, meaning it's a large trial to see how well the new treatment works compared to existing ones.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

735

Start

08 Aug 2023

Estimated completion

01 Jul 2035

Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Chronic Lymphocytic Small-Cell Lymphoma Lymphoma, Small Lymphocytic CLL SLL

What is this study about?

This study, called BELLWAVE-010, is designed for people who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These are types of cancer that start in white blood cells. The study is specifically for individuals whose cancer has either come back after previous treatment, or hasn't responded well to earlier treatments.

The main aim of this research is to compare two different treatment combinations. One combination uses an investigational drug called Nemtabrutinib along with another medicine called Venetoclax. The other combination, which is a standard treatment, involves Venetoclax and Rituximab. The researchers want to find out if the Nemtabrutinib and Venetoclax combination is better at stopping the cancer from growing or spreading for longer, and if it's safe for patients to use.

This is a Phase 3 clinical trial, which means it's a large, important study. It helps determine if a new treatment is effective and safe enough to potentially become a new standard treatment. By taking part, you could help doctors learn more about the best ways to treat CLL/SLL, which could benefit many patients in the future.

Key takeaways

This study is for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or hasn't responded to previous treatment.
It compares a new treatment combination (Nemtabrutinib + Venetoclax) with a standard treatment (Venetoclax + Rituximab).
The main goal is to see if the new combination can keep the cancer from getting worse for longer.
This is a Phase 3 study, meaning it's a large trial to find out if the new treatment is effective and safe.
Participation involves regular hospital visits for treatments and health checks.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must have been diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that is active and needs treatment. Your cancer should have come back or not responded to at least one previous treatment. You also need to be well enough to take part, meaning you can look after yourself and have healthy enough organs.

There are also some specific health conditions that might prevent you from joining the study. For example, if you have an active hepatitis B or C infection, or certain other health issues, you might not be able to participate. The study team will check your full medical history to make sure it's safe for you to take part.

If you're a woman who could become pregnant, you'll need to use effective birth control during the study and for a period after. Men will also need to use birth control for a certain time due to the study medications. The study team will discuss all of these details with you.

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 chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
My cancer has come back or hasn't responded to at least one previous treatment.
My general health is good enough to take part in a study.
I am able to swallow tablets.
If I am a woman, I am not pregnant or breastfeeding, and I am willing to use effective birth control if needed.
If I am a man, I am willing to use effective birth control if needed.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given one of the two treatment combinations (Nemtabrutinib plus Venetoclax, or Venetoclax plus Rituximab). You'll have regular hospital visits for check-ups, blood tests, and to receive your medication. Some medications might be taken by mouth, while others might be given as an infusion.

These visits will involve assessments to monitor your health, how the treatment is working, and to check for any side effects. The exact number of visits and the total length of your participation will be explained by the study team. You'll also have a follow-up period after your main treatment is complete to continue monitoring your health.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as access to new or different treatments for your condition that are not yet widely available. The information gained from your participation could also help others with similar conditions in the future. However, there are also potential risks, as with any medical treatment. The medicines might have side effects, which the study team will carefully monitor. You will receive detailed information about all possible risks and side effects before you decide to join. Remember, you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (54)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Highlands Oncology Group ( Site 5405)
Verified postcode
Springdale, United States· Recruiting
MemorialCare Health System - Long Beach Medical Center ( Site 5421)
Verified postcode
Long Beach, United States· Recruiting
Memorial Hospital West ( Site 5410)
Verified postcode
Pembroke Pines, United States· Recruiting
Oregon Health and Science University ( Site 5425)
Verified postcode
Portland, United States· Recruiting
Medical Oncology Associates, PS ( Site 5406)
Verified postcode
Spokane, United States· Recruiting
University of Wisconsin Hospital and Clinics-Carbone Cancer Center ( Site 5423)
Verified postcode
Madison, United States· Completed
Instituto Alexander Fleming ( Site 1005)
Unverified
Ciudad Autónoma de Buenos Aires, Argentina· Recruiting
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1007)
Verified postcode
Mar del Plata, Argentina· Recruiting
Sanatorio Parque ( Site 1003)
Verified postcode
Rosario, Argentina· Recruiting
Centro Medico Fleischer ( Site 1006)
Verified postcode
Buenos Aires, Argentina· Recruiting
Hospital Aleman-oncohematologic diseases ( Site 1001)
Verified postcode
Buenos Aires, Argentina· Recruiting
Royal Adelaide Hospital ( Site 1104)
Verified postcode
Adelaide, Australia· Recruiting

Common questions

What is Nemtabrutinib?

Nemtabrutinib is a new drug being tested in this study for treating CLL/SLL. It works differently from other medicines.

What is the difference between CLL and SLL?

CLL and SLL are essentially the same cancer. CLL mainly affects the blood and bone marrow, while SLL mainly affects the lymph nodes.

What does 'relapsed or refractory' mean?

This means your cancer has either come back after improving with previous treatment (relapsed) or it hasn't responded well to past treatments (refractory).

Will I know which treatment I'm getting?

No, this study is 'blinded,' meaning neither you nor your doctor will know which specific treatment combination you are receiving to keep the results fair and unbiased.

What is a Phase 3 study?

A Phase 3 study is a large study that compares a new treatment with an existing standard treatment. It's done to see if the new treatment is better and safer.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.