Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.

This study is investigating new ways to start giving a medicine called sonrotoclax to people with certain blood cancers, such as Chronic Lymphocytic Leukemia (CLL). Sonrotoclax works by blocking a protein that helps cancer cells survive. When starting this type of medicine, doctors gradually increase the dose over time to prevent side effects. This study aims to find simpler and faster, yet still safe, ways to do this. Researchers will also look at how sonrotoclax works alongside another approved medicine called zanubrutinib. The main goal is to make sure these new dosing schedules are safe. The study will happen in two parts: first testing schedules in a few people, then in more if they seem safe. The total time for participation is about 17 months.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

BeiGene

Enrolment target

Start

23 Jan 2025

Estimated completion

31 Dec 2027

Chronic Lymphocytic Leukemia CLL

What is this study about?

This study is about making treatments for certain blood cancers, like Chronic Lymphocytic Leukemia (CLL), even safer and more effective. We're focusing on a new experimental medicine called sonrotoclax. Sonrotoclax works by targeting a specific protein in cancer cells that helps them grow and survive. By blocking this protein, the medicine encourages these cancer cells to die off. This can be very helpful for people with CLL and similar conditions.

When starting medicines like sonrotoclax, it's very important to begin with a small dose and gradually increase it over time. This careful approach helps prevent a type of reaction called 'tumor lysis syndrome,' which can happen when many cancer cells break down too quickly. Doctors are always looking for the best way to do this ramp-up – making it as safe as possible while also being straightforward and efficient for patients. This study will test different new ways to gradually increase the sonrotoclax dose.

Another medicine, zanubrutinib, which is already approved for CLL and works in a similar way by blocking a different protein in cancer cells, may also be part of the treatment for some participants. This study will involve people from various locations around the world, and we expect each person to be involved for about 17 months in total.

Key takeaways

New study for people with Chronic Lymphocytic Leukemia (CLL).
Tests new, potentially simpler ways to start a medicine called sonrotoclax.
Aims to find the safest gradual dose increase schedule.
May involve another existing medicine called zanubrutinib.
Participation lasts about 17 months with close medical monitoring.

Who may be eligible?

To join this study, people generally need to be at least 18 years old. You would need to have Chronic Lymphocytic Leukemia (CLL) that requires treatment, and your general health should be stable enough to take part. This means your body's organs, like your kidneys and liver, are working well.

There are also some specific health conditions that would prevent someone from joining. For example, if you've had major surgery very recently, or have certain uncontrolled autoimmune conditions, or active infections like some types of hepatitis or HIV that aren't properly managed, you might not be able to participate. Also, if you've had previous treatments for your CLL, or certain other types of blood cancers linked to CLL, it might mean you're not eligible.

If you are a woman who could become pregnant, you would need to agree to use effective birth control during the study and for a period after your last dose of the study medicines. Your study doctor and nurse will be able to discuss all the requirements with you in much more detail.

Quick self-check

Are you 18 years old or older?
Do you have Chronic Lymphocytic Leukemia (CLL) that your doctor says needs treatment?
Are you generally feeling well and stable enough for a study like this?
Do you not have major uncontrolled infections (like certain types of hepatitis or HIV)?
Have you not had major surgery in the last 4 weeks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will first have some tests to check if you are eligible and to get a baseline understanding of your health. Once enrolled, you will receive the study medicine, sonrotoclax, and potentially zanubrutinib, following a new gradual dosing plan. This means the dose of sonrotoclax will slowly increase over the first few weeks.

Throughout the study, you will have regular visits to the clinic for check-ups, blood tests, and scans (like CT or MRI) to see how you are responding to the treatment and to monitor for any side effects. The first part of the study involves a small group of people to carefully check the new dosing schedules. If a schedule seems safe, it will then be tested in a larger group.

The total time you would be involved in this study is expected to be around 17 months. Your doctors and nurses will always be on hand to explain what's involved at each step.

Potential risks and benefits

Taking part in a study like this offers the potential benefit of accessing new treatments before they are widely available. The goal is to find safer and more straightforward ways to start sonrotoclax, which could lead to better outcomes for patients with CLL. However, as with any medicine, there are potential risks and side effects. Sonrotoclax is an experimental drug, meaning its full effects and side effects are still being understood. The study specifically focuses on monitoring for tumor lysis syndrome and other related side effects. You will be closely monitored by the study team, and they will explain all known potential risks to you. Remember, participating is completely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (17)

Moffitt Cancer Center
Tampa, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, United States
The University of Kansas Cancer Center
Westwood, United States
Dana Farber Cancer Institute
Boston, United States
Washington University School of Medicine
St Louis, United States
Fred Hutchinson Cancer Research Center
Seattle, United States
Blacktown Cancer and Haematology Centre
Blacktown, Australia
Genesiscare St Andrews
Adelaide, Australia
Cabrini Hospital Malvern
Malvern East, Australia
The Alfred Hospital
Melbourne, Australia
Rockingham Hospital
Cooloongup, Australia
Linear Clinical Research
Nedlands, Australia

+5 more sites — see the official record for the full list.

Common questions

What is Chronic Lymphocytic Leukemia (CLL)?

CLL is a type of cancer that affects white blood cells called lymphocytes. These cells grow out of control in the bone marrow and blood.

What is sonrotoclax?

Sonrotoclax is a new medicine being tested. It works by blocking a protein in cancer cells that helps them survive, which then makes the cancer cells die.

Why do doctors gradually increase the dose of sonrotoclax?

Gradually increasing the dose (called 'ramp-up') helps your body get used to the medicine and reduces the risk of side effects, especially one called tumor lysis syndrome, which can happen when cancer cells break down too quickly.

What is zanubrutinib?

Zanubrutinib is another medicine already approved for CLL. It also works by blocking a protein to help control cancer cells.

How long will I be involved in this study?

If you join, your participation in the study is expected to last for about 17 months.