RecruitingPHASE3INTERVENTIONAL

A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)

This important UK study is testing a new treatment approach for adults living with Mantle Cell Lymphoma (MCL), a type of blood cancer. The main goal is to compare a new combination of drugs, sonrotoclax and zanubrutinib, against zanubrutinib combined with a dummy drug (placebo). This is for people whose MCL has either returned after previous treatment or hasn't responded as expected. Researchers want to find out how effective this new combination is at treating the cancer and also to understand its safety. The study involves two groups: one receiving the new drug combination and the other receiving zanubrutinib plus a placebo. This helps doctors see if adding sonrotoclax makes a meaningful difference for patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

BeOne Medicines

Enrolment target

300

Start

05 Mar 2025

Estimated completion

30 Mar 2032

Mantle Cell Lymphoma B Cell Lymphoma

What is this study about?

This study, called CELESTIAL-RRMCL, is focused on finding better ways to treat Mantle Cell Lymphoma (MCL) in adults. MCL is a type of cancer that affects white blood cells called B-cells. For some people, MCL can be challenging to treat, especially if it comes back after being treated before (we call this 'relapsed') or if it doesn't respond to previous treatments ('refractory').

The study aims to investigate a new combination of medicines: sonrotoclax and zanubrutinib. Zanubrutinib is already used to treat MCL. Researchers want to see if adding sonrotoclax to zanubrutinib makes the treatment more effective. To do this, they will compare this new combination with zanubrutinib given alongside a 'placebo' – which looks like the real drug but contains no active medicine. This helps them understand the true effect of sonrotoclax.

By comparing these two groups, the study hopes to discover if the new combination can help control the cancer better and for longer. They will also carefully monitor any side effects to ensure the treatment is safe for patients. Finding new and effective treatments is really important for people living with MCL, especially when standard treatments haven't worked or have stopped working.

Key takeaways

This study is testing a new combination drug therapy for Mantle Cell Lymphoma.
It's for adults whose cancer has relapsed (come back) or is refractory (not responding).
The new combination is sonrotoclax plus zanubrutinib.
The study compares this to zanubrutinib plus a placebo (dummy drug).
The main goals are to check how well it works and if it's safe.
Participation involves regular hospital visits for checks and tests.

Who may be eligible?

This study is looking for adults who have been diagnosed with Mantle Cell Lymphoma (MCL). Your MCL must have either come back after you've had previous treatments, or it hasn't responded to earlier treatments.

You would need to have had between one and five different treatments for your MCL already. This must include a type of immune therapy or chemoimmunotherapy.

There are also some reasons why you might not be able to join, such as if you've already had certain newer types of cancer medicines (like some BCL2 inhibitors or BTK inhibitors), or if your cancer has spread to your brain or spinal cord. Having certain heart conditions or a recent stroke would also prevent you from taking part.

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.

Have you been diagnosed with Mantle Cell Lymphoma (MCL)?
Has your MCL come back or not responded to previous treatments?
Have you had between 1 and 5 previous treatments for your MCL, including a type of immune therapy?
Have you *not* had certain newer targeted therapies (like BCL2 inhibitors or BTK degraders) before?
Do you *not* have MCL that has spread to your brain or spinal cord?
Are you generally well enough to take part in a study, as judged by your doctor?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to one of two groups by chance – like flipping a coin. One group will receive sonrotoclax plus zanubrutinib, and the other will receive zanubrutinib plus a placebo (a dummy drug). You'll take these medications as prescribed. You'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor your health. Your specialist will explain the exact schedule of visits and tests. The total duration of your participation will depend on how you respond to the treatment, but you would likely be followed for an extended period, potentially several years, to track your progress and long-term health. More details on the timing and types of assessments would be discussed with you by the study team.

Potential risks and benefits

Taking part in this study might mean you gain access to a new treatment combination that isn't widely available yet, which could potentially help control your Mantle Cell Lymphoma. However, like all medications, the study drugs may have side effects, and some could be serious. You might also experience side effects without any benefit to your cancer. There's also no guarantee that the new combination will be more effective than standard treatment. Your doctors will carefully explain all known risks. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (152)

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

University of Alabama At Birmingham Hospital
Verified postcode
Birmingham, United States· Recruiting
University of Arizona Cancer Center
Verified postcode
Tucson, United States· Recruiting
Ucsf Fresno
Verified postcode
Fresno, United States· Recruiting
Kaiser Permanente Southern California
Verified postcode
Irvine, United States· Recruiting
Yale University Yale Cancer Center
Verified postcode
New Haven, United States· Recruiting
Memorial Cancer Institute, Memorial Healthcare System
Verified postcode
Pembroke Pines, United States· Recruiting
Cleveland Clinic Florida
Verified postcode
Weston, United States· Recruiting
Rush University Medical Center
Verified postcode
Chicago, United States· Recruiting
Fort Wayne Medical Oncology and Hematology
Verified postcode
Fort Wayne, United States· Recruiting
Mission Cancer and Blood
Verified postcode
Waukee, United States· Recruiting
University of Maryland Greenebaum Comprehensive Cancer Center
Verified postcode
Baltimore, United States· Recruiting
Dana Farber Cancer Institute Longwood Medical Center
Verified postcode
Boston, United States· Recruiting

Common questions

What is Mantle Cell Lymphoma?

Mantle Cell Lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system. It can affect your lymph nodes, spleen, and bone marrow.

What does 'relapsed/refractory' mean?

If your cancer is 'relapsed', it means it has returned after being treated. If it's 'refractory', it means it hasn't responded to previous treatments.

What is a 'placebo'?

A placebo is an inactive substance that looks just like the real medicine but doesn't contain any active drug. It helps researchers compare the effects of the active medicine more clearly.

Will I know which treatment I'm receiving?

In this type of study, participants usually don't know whether they are receiving the active new medication or the placebo. This is to ensure the study results are fair and unbiased.

Who is sponsoring this study?

This study is sponsored by a company now known as BeOne Medicines, which was previously called BeiGene.

How to find out more

Study Director

clinicaltrials@beonemed.com 1.877.828.5568 Official trial record

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