Study on Zanubrutinib, Tislelizumab, and Sonrotoclax for Patients with Richter Transformation (a type of lymphoma)

2 1 1

What is this study about?

This clinical trial is focused on studying a condition known as Richter Transformation, which occurs in some patients with Chronic Lymphocytic Leukemia (CLL). The study is exploring the effectiveness and safety of a combination of treatments. These treatments include Zanubrutinib (also known by its code name BGB-3111), which is a type of medication called a BTK inhibitor, and Tislelizumab (BGB-A317), a PD-1 inhibitor. Additionally, the study will evaluate the use of Sonrotoclax (BGB-11417), a BCL2 inhibitor, in some patients.

The purpose of the study is to assess how well these medications work together in treating patients with Richter Transformation. Participants in the study will receive these medications either in combination or separately, depending on the study group they are assigned to. The study will monitor the patients over a period to observe the effects of the treatment on their condition.

Throughout the study, patients will be given the medications in specific forms: Zanubrutinib is taken as a capsule, Tislelizumab is administered as a solution for infusion, and Sonrotoclax is provided as a film-coated tablet. The study aims to provide valuable information on the potential benefits and safety of these treatments for patients with Richter Transformation.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

Eligibility criteria include a confirmed diagnosis of chronic lymphocytic leukemia (CLL) with Richter transformation, adequate bone marrow and liver function, and a life expectancy of at least three months.

2 treatment initiation

The treatment phase begins with the administration of zanubrutinib and tislelizumab. Zanubrutinib is taken orally in the form of capsules, while tislelizumab is administered intravenously as a solution for infusion.

The dosage and frequency of administration are determined by the study protocol and are monitored by the clinical team.

3 combination therapy

In some cases, the treatment may include sonrotoclax in addition to zanubrutinib and tislelizumab. Sonrotoclax is taken orally as film-coated tablets.

The decision to include sonrotoclax is based on individual patient response and tolerance to the initial treatment.

4 monitoring and evaluation

Throughout the treatment, regular monitoring is conducted to evaluate the effectiveness and safety of the therapy. This includes blood tests, imaging studies, and clinical assessments.

The primary goal is to assess the overall response rate after six cycles of treatment, which may include complete or partial response.

5 follow-up

After completing the treatment cycles, follow-up visits are scheduled to monitor long-term outcomes and any potential side effects.

These visits help ensure ongoing health and well-being, as well as the collection of data for the study’s final analysis.

Who Can Join the Study?

Must have a confirmed diagnosis of CLL (Chronic Lymphocytic Leukemia) according to specific criteria.
Must have a life expectancy of at least 3 months.
Must be able and willing to provide written consent and follow the study schedule and requirements.
Must have a confirmed diagnosis of RT (Richter Transformation), which is a type of lymphoma.
Must have either not been treated for RT before or have responded to or not tolerated the first treatment for RT.
Must have adequate bone marrow function, which means having enough blood cells to fight infections and prevent bleeding.
Must have a creatinine clearance of at least 30 ml/min, which is a measure of kidney function.
Must have adequate liver function, which means the liver is working well enough to process substances in the body.
Must test negative for hepatitis B, hepatitis C, and HIV within 6 weeks before joining the study.
Must be at least 18 years old.
Must have an ECOG performance status of 0-2, which is a scale that measures how well a person can perform daily activities. A status of 3 is allowed if it is due to CLL or RT.

Who Cannot Join the Study?

Patients who have not been treated for Richter Transformation before or have only had one previous treatment for it.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Rostock University Medical Center	Rostock	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH	Paderborn	Germany
Dr. Vehling-Kaiser MVZ GmbH	Landshut	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Universitaetsklinikum Ulm AöR	Ulm	Germany
Rigshospitalet	Copenhagen	Denmark
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Umpnwyputq Hctdisrt Cjtuhlg	Cologne	Germany
Uyahrnncaobebypfhdntv Eaznn Azm	Essen	Germany

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	18.02.2020
Denmark	Recruiting	18.02.2020
Germany	Recruiting	18.02.2020

Trial locations

Investigated drugs:

Zanubrutinib is a medication used in this trial that works by blocking a protein called BTK. This protein is involved in the growth of cancer cells. By inhibiting BTK, zanubrutinib helps to slow down or stop the growth of cancer cells in patients with certain types of blood cancer.

Tislelizumab is another medication in the trial that targets a protein called PD-1. This protein can prevent the immune system from attacking cancer cells. By blocking PD-1, tislelizumab helps the immune system to recognize and destroy cancer cells more effectively.

Sonrotoclax is a medication that targets a protein called BCL2, which helps cancer cells survive. By inhibiting BCL2, sonrotoclax can promote the death of cancer cells, making it a potential treatment option for patients with certain types of blood cancer.

Richter Transformation – This is a condition where chronic lymphocytic leukemia (CLL) transforms into a more aggressive type of lymphoma, most commonly diffuse large B-cell lymphoma (DLBCL). It is characterized by a sudden change in the behavior of the disease, with symptoms that may include rapidly enlarging lymph nodes, fever, night sweats, and weight loss. The transformation can occur spontaneously or after treatment for CLL. The progression involves a shift from a slow-growing cancer to a fast-growing one, requiring different management strategies. The exact cause of this transformation is not fully understood, but it involves genetic changes in the cancer cells.

Trial ID:

2023-504653-12-00

Protocol code:

CLL-RT1

NCT ID:

NCT04271956

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Zanubrutinib, Tislelizumab, and Sonrotoclax for Patients with Richter Transformation (a type of lymphoma)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?