RecruitingPHASE3INTERVENTIONAL

A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)

This UK-based study is for adults with a type of blood cancer called chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or hasn't responded well to previous treatments. It aims to find out if new drug combinations, sonrotoclax with obinutuzumab or sonrotoclax with rituximab, are better than the current standard treatment, venetoclax with rituximab. Researchers will compare how well these treatments stop the cancer from growing (called progression-free survival) and how safe they are. The results will help doctors understand the best ways to treat patients facing this challenging stage of their cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

BeOne Medicines

Enrolment target

630

Start

11 Jun 2025

Estimated completion

01 Dec 2031

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

What is this study about?

This study, called CELESTIAL-RRCLL, is looking into new ways to treat a type of blood cancer known as chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). These conditions affect white blood cells and can sometimes be challenging to treat, especially if they return after initial treatment or don't respond well to existing medicines. This study focuses on adults in the UK whose cancer has unfortunately come back (relapsed) or hasn't responded as hoped to other treatments (refractory).

The main goal is to compare some newer drug combinations with a treatment that's currently used. Specifically, researchers want to see if combining a drug called sonrotoclax with either obinutuzumab or rituximab works better at keeping the cancer under control compared to the combination of venetoclax and rituximab. 'Works better' means seeing if these new combinations can stop the cancer from growing or spreading for a longer time. They will also carefully check for side effects to understand how safe the new combinations are.

Finding more effective and safer treatments is really important for patients with CLL/SLL, especially when their cancer has been difficult to manage. Studies like this help to improve future care and give patients more options. It's a 'Phase 3' study, which means these treatments have already been tested in smaller groups and are now being compared more widely to existing treatments.

Key takeaways

This study is for adults with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or not responded well to past treatments.
It's comparing new drug combinations (sonrotoclax with obinutuzumab or rituximab) to a standard treatment (venetoclax with rituximab).
The main goals are to see which treatment works best at controlling the cancer and which has fewer side effects.
Participation involves regular clinic visits, taking study medication, and close monitoring by doctors.
The study aims to find better treatment options for patients in the UK with challenging CLL/SLL.

Who may be eligible?

This study is looking for adults who have been officially diagnosed with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) and have already had at least one previous treatment for their condition. You'd need to have had at least two cycles of any past treatments.

Even if you've previously taken a BCL2 inhibitor (a specific type of drug), you might still be able to join, but only if your cancer remained stable for at least three years after that treatment, and it's been at least two years since you last took it. You also need to be generally well enough to participate, with good organ function, and be able to carry out your daily activities without too much difficulty.

However, you wouldn't be able to join if you have certain other serious health issues, such as active Richter's transformation (a more aggressive form of CLL/SLL), severe lung or heart problems, or if your cancer has spread to your brain or spinal cord. Also, if you've recently had certain types of stem cell transplants or CAR T-cell therapy, or if you're experiencing graft-versus-host disease (a complication of some transplants), you wouldn't be eligible.

Quick self-check

Are you an adult (18 or older)?
Do you have a diagnosis of CLL or SLL?
Have you already received at least one prior treatment for your CLL/SLL (at least 2 cycles of it)?
Are you generally well enough for daily activities?
Do you have good overall organ function (kidneys, liver, etc.)?
Do you NOT have severe heart or lung problems, or current Richter's transformation?

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

What does participation involve?

Taking part in this study would involve regular visits to the clinic for check-ups and assessments. You would receive one of the study medications, typically given as a combination of two drugs. These could be sonrotoclax plus obinutuzumab, sonrotoclax plus rituximab, or venetoclax plus rituximab, depending on which group you are assigned to. Doctors and nurses will monitor your health closely, including taking blood samples, performing scans, and asking about any side effects you might experience. The total duration of your participation in the study would depend on how your cancer responds to treatment and how long you continue to benefit from the medication. There will also be follow-up appointments after you finish the main treatment period to see how you are doing long-term.

Potential risks and benefits

By taking part, you might benefit from receiving a new treatment that could be more effective than current options for CLL/SLL that has come back or is difficult to treat. You would also receive very close medical care and monitoring. However, as with any medical treatment, there are potential risks, including side effects from the study medications. These will be carefully explained to you by the study team. It's important to remember that joining a study is always your voluntary choice, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (173)

Uci Health Laguna Hills
Laguna Hills, United States· Recruiting
Chao Family Comprehensive Cancer Center
Orange, United States· Recruiting
Stanford Cancer Institute
Palo Alto, United States· Recruiting
Scripps Prebys Cancer Center
San Diego, United States· Recruiting
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, United States· Recruiting
Yale University Yale Cancer Center
New Haven, United States· Recruiting
Eastern Connecticut Hematology and Oncology
Norwich, United States· Recruiting
Cleveland Clinic Florida
Weston, United States· Recruiting
Northwestern University
Chicago, United States· Recruiting
Illinois Cancer Specialists (Niles) Usor
Niles, United States· Recruiting
University of Louisville, Brown Cancer Center
Louisville, United States· Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, United States· Recruiting

+161 more sites — see the official record for the full list.

Common questions

What is chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)?

These are types of cancer that affect white blood cells, specifically lymphocytes, which are important for your immune system. They are closely related conditions.

What does 'relapsed and/or refractory' mean?

Relapsed means your cancer has come back after treatment. Refractory means your cancer didn't respond well to previous treatments.

What are 'interventions' in a study?

In a clinical study, 'interventions' are the different treatments or procedures being tested or compared. In this case, they are specific drug combinations.

Will I know which treatment I'm getting?

This type of study often involves 'blinding,' where neither you nor your doctor knows which specific treatment you are receiving until the study is over. This helps ensure fair results.

Who is sponsoring this study?

The study is sponsored by a company called BeOne Medicines, which was previously known as BeiGene. You might see both names mentioned for this study.

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.