Active not recruitingPHASE2INTERVENTIONAL

A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

This research study is investigating a new medication called Sonrotoclax for adults living with Waldenström Macroglobulinemia (WM), a type of blood cancer. The study will look at how safe and effective Sonrotoclax is when given on its own to patients whose previous treatments haven't worked well or whose cancer has returned. It will also be tested in combination with another drug, Zanubrutinib, for those who haven't received any treatment for their WM yet. The main goals are to see if the treatment can reduce the signs and symptoms of WM, or even make the cancer disappear, and to understand any side effects people might experience. Sonrotoclax works by targeting a protein called BCL2, which is often found in high levels in people with WM.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

BeOne Medicines

Enrolment target

114

Start

23 Oct 2023

Estimated completion

01 Aug 2028

Waldenstrom Macroglobulinemia Waldenstrom's Macroglobulinemia Recurrent Waldenstrom's Macroglobulinemia Refractory

What is this study about?

This study is a research project designed to help us understand more about a new treatment for Waldenström Macroglobulinemia (WM). WM is a rare type of cancer that affects certain white blood cells. The new drug being studied is called Sonrotoclax. Researchers want to see if Sonrotoclax can help improve the health of people with WM.

The study will explore two main areas. Firstly, it will look at Sonrotoclax by itself in people who have already had treatment for their WM, but it hasn't worked as hoped, or their cancer has come back. Secondly, it will combine Sonrotoclax with another existing drug, Zanubrutinib, for people who are newly diagnosed with WM and haven't started any treatment yet. The main things the study will measure are whether the cancer shrinks or disappears, and what kind of side effects, if any, people experience.

Sonrotoclax works by targeting a specific protein called BCL2, which plays a role in how cancer cells survive. In many cancers, including WM, this protein can be overactive. By blocking BCL2, scientists hope to stop the cancer cells from growing and encourage them to die. This worldwide study plans to involve about 105 adult participants and will last for approximately five years. You might see the study sponsored by BeiGene or BeOne Medicines, as the company recently changed its name.

Key takeaways

This study evaluates a new drug, Sonrotoclax, for Waldenström Macroglobulinemia (WM).
It's being tested alone for previously treated WM and with Zanubrutinib for untreated WM.
Sonrotoclax targets a protein involved in cancer cell survival.
The study aims to understand the treatment's safety and effectiveness.
Participation involves taking daily pills and regular check-ups over several years.
It's a 'Phase 2' study, meaning it's exploring safety and early signs of effectiveness.

Who may be eligible?

To be considered for this study, you would need to have a confirmed diagnosis of Waldenström Macroglobulinemia (WM). Your medical team would also need to confirm that your WM meets certain guidelines for requiring treatment.

For some parts of the study, you would need to have WM that has either come back after treatment, or hasn't responded well to previous treatments. For another part of the study, it's important that you haven't received any prior treatment for your WM, apart from a procedure called plasmapheresis if you needed it.

There are also some things that would prevent you from taking part. For example, if your WM has spread to your brain or spinal cord, or if your WM has changed into a more aggressive form of lymphoma. You also wouldn't be able to participate if you've had another type of cancer within the last two years, or have an uncontrolled infection.

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 a confirmed diagnosis of Waldenström Macroglobulinemia (WM).
My WM requires treatment according to my doctor.
I am an adult aged 18 or older.
My WM is either relapsed/refractory OR I have not received previous treatment for WM.
My WM has not spread to my brain or spinal cord.
I do not have an uncontrolled infection at the moment.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medication, Sonrotoclax, as a pill that you take by mouth. The overall study will involve regular visits and assessments with the study team to monitor your health, how you're responding to the treatment, and any side effects you might experience. These assessments typically include blood tests, physical examinations, and possibly scans or other tests to check on your WM. The total time commitment for individual participants in the study could be up to approximately five years, including treatment and follow-up.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing new treatments before they are widely available. While Sonrotoclax is being carefully studied, there's no guarantee it will work for everyone, and like all medications, it may have side effects. Potential risks will be thoroughly explained to you, including common and serious side effects observed so far. It's important to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard care.

Locations (72)

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

City of Hope National Medical Center
Verified postcode
Duarte, United States
Colorado Blood Cancer Institute
Verified postcode
Denver, United States
Medstar Georgetown University Hospital
Verified postcode
Washington D.C., United States
University of Miami
Verified postcode
Miami, United States
Northwestern Medicine Cancer Center
Verified postcode
Warrenville, United States
Mission Cancer and Blood
Verified postcode
Waukee, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Verified postcode
Baltimore, United States
Dana Farber Cancer Institute
Verified postcode
Boston, United States
Mayo Clinic Rochester
Verified postcode
Rochester, United States
Hattiesburg Hematology and Oncology Clinic
Verified postcode
Hattiesburg, United States
Memorial Sloan Kettering Cancer Center Mskcc
Verified postcode
New York, United States
Atrium Health Levine Cancer Institute (Lci)
Verified postcode
Charlotte, United States

Common questions

What is Waldenström Macroglobulinemia?

It's a rare type of slow-growing blood cancer that affects certain white blood cells called lymphocytes, leading to too many abnormal cells in the bone marrow.

What does 'Relapsed/Refractory' mean?

Relapsed means your cancer came back after treatment. Refractory means your cancer didn't respond well to treatment, or it got worse while you were on treatment.

How does Sonrotoclax work?

Sonrotoclax targets a protein called BCL2, which helps cancer cells survive. By blocking this protein, the drug aims to stop cancer cell growth and encourage them to die.

Is Sonrotoclax available to everyone?

No, Sonrotoclax is an investigational drug, meaning it's still being studied in clinical trials and is not yet approved or available for general use.

What happens after the study ends?

After the study, the researchers will analyse all the information gathered. If the treatment is found to be safe and effective, it may eventually become a standard treatment option for WM, usually after further studies and approval from health authorities.