Efficacy and Safety of Zanubrutinib Plus Tislelizumab Treatment with or Without Sonrotoclax for Patients with Richter Transformation
This research study, called CLL-RT1, is testing new ways to treat a specific type of cancer called Richter Transformation (RT). RT is a serious condition where chronic lymphocytic leukaemia (CLL) changes into a more aggressive lymphoma. We are looking at combining two existing cancer drugs, zanubrutinib and tislelizumab, and sometimes adding a third drug called sonrotoclax. The main goal is to find out if these combinations are safe and effective for people with RT. Currently, treatment options for RT are limited, and we hope this study will lead to better outcomes for patients. This study is for adults aged 18 and over who have been diagnosed with Richter Transformation.
At a glance
What is this study about?
This study is investigating new treatments for a condition called Richter Transformation (RT). RT happens when a type of blood cancer called chronic lymphocytic leukaemia (CLL) becomes more aggressive, turning into a different kind of cancer, usually a diffuse large B-cell lymphoma. Currently, treating RT is very challenging, and the available treatments haven't shown much success, often leading to poor outcomes for patients.
Because current treatments are not as effective as we'd like, there's a strong need to find better options. This study aims to test new combinations of medicines. We are focusing on two drugs, zanubrutinib and tislelizumab, which work in different ways to fight cancer. Zanubrutinib blocks certain signals that help cancer cells grow, while tislelizumab helps our body's immune system recognise and attack cancer cells. In some parts of the study, we might also add a third drug called sonrotoclax.
The main purpose of this study is to see how safe these drug combinations are and how well they work in people with Richter Transformation. By carefully studying these new approaches, we hope to improve the chances of successful treatment for patients and offer better hope for those affected by this difficult condition.
Key takeaways
- This study is for adults with Richter Transformation (RT), a serious blood cancer.
- It tests new combinations of existing and potential new cancer drugs.
- The goal is to find safer and more effective treatments for RT.
- You will have regular health checks and doctor visits if you join.
- Participation helps scientists learn more about treating RT.
Who may be eligible?
To join this study, doctors will first check if you meet certain requirements. You need to have a confirmed diagnosis of Richter Transformation. This study is open to patients who haven't had treatment for RT before, or those who responded well to their first treatment but can't continue it, or didn't tolerate it well. Your general health, including how well your blood, kidneys, and liver are working, will be carefully checked. You must be at least 18 years old.
There are also reasons why someone might not be able to join. For example, if your previous treatment for RT didn't work at all, you might not be eligible. The study team will review your medical history and test results to make sure it's safe for you to participate and that the study is the right fit.
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 Richter Transformation.
- I am at least 18 years old.
- My doctors consider my general health, including blood, kidney, and liver function, to be suitable.
- I have not had previous treatment for RT, or my first treatment worked well but I couldn't continue it.
- I am able and willing to attend all study appointments and follow instructions.
What does participation involve?
If you decide to take part in this study, you will receive either a combination of zanubrutinib and tislelizumab, or these two drugs with sonrotoclax. You will have regular visits to the hospital or clinic, where the study team will monitor your health closely. This will include blood tests, physical examinations, and other checks to see how you are responding to the treatment and to look for any side effects. These visits will be more frequent at the beginning of the study and may become less so over time. The total length of your participation will depend on how you respond to the treatment and the study plan, but there will be a follow-up period after your treatment ends to continue monitoring your health.
Potential risks and benefits
Locations (11)
- Allgemeines Krankenhaus der Stadt WienVerified postcodeVienna, Austria· Recruiting
- RigshospitaletVerified postcodeCopenhagen, Denmark· Recruiting
- Charité BerlinVerified postcodeBerlin, Germany· Not yet recruiting
- Uniklinik KölnVerified postcodeCologne, Germany· Recruiting
- Universitätsklinikum Carl Gustav CarusVerified postcodeDresden, Germany· Recruiting
- Universitätsklinikum EssenVerified postcodeEssen, Germany· Recruiting
- Universitätsklinikum Schleswig-Holstein Campus KielVerified postcodeKiel, Germany· Recruiting
- H.O.T Praxis LandshutVerified postcodeLandshut, Germany· Recruiting
- Brüderkrankenhaus St. Josef PaderbornVerified postcodePaderborn, Germany· Recruiting
- Universitätsmedizin RostockVerified postcodeRostock, Germany· Recruiting
- Universitätsklinik UlmVerified postcodeUlm, Germany· Recruiting
Common questions
What is Richter Transformation (RT)?
Richter Transformation is when a slower-growing blood cancer, called Chronic Lymphocytic Leukaemia (CLL), changes into a more aggressive form of lymphoma, usually diffuse large B-cell lymphoma.
What are zanubrutinib and tislelizumab?
Zanubrutinib is a drug that blocks signals in cancer cells, stopping them from growing. Tislelizumab helps your body's immune system fight the cancer.
What is a Phase 2 trial?
A Phase 2 trial is a stage of research where doctors test if a new treatment is effective and if it has any side effects in a larger group of patients after it has been shown to be safe in a small group.
Will I receive all three drugs?
The study is testing combinations of these drugs. You might receive zanubrutinib and tislelizumab, and in some parts of the study, sonrotoclax may also be included.
How long will the study last for me?
The exact duration for each patient varies, depending on how you respond to the treatment. There will also be a period of follow-up after your treatment finishes.
How to find out more
Barbara Eichhorst, Prof.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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