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

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 trial?

1 criterion

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

What is already known about the treatment

  • Zanubrutinib

    Zanubrutinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating patients with Richter Transformation, a condition associated with chronic lymphocytic leukemia. It is a Bruton’s tyrosine kinase (BTK) inhibitor, which works by blocking the BTK enzyme involved in the growth and survival of cancer cells. This medication is classified as a targeted cancer therapy and is being evaluated for its safety and efficacy in combination with other drugs.

  • Tislelizumab

    Tislelizumab is given through intravenous infusion and is under investigation in clinical trials for its role in treating Richter Transformation in patients with chronic lymphocytic leukemia. It is a PD-1 inhibitor, which helps the immune system recognize and attack cancer cells by blocking the PD-1 pathway that tumors use to evade immune detection. This medication falls under the category of immunotherapy and is being tested for its potential benefits when used alongside other treatments.

  • Sonrotoclax

    Sonrotoclax is administered orally and is being explored in clinical trials for its potential in treating Richter Transformation. It acts as a BCL2 inhibitor, targeting proteins that prevent cancer cell death, thereby promoting the elimination of cancerous cells. This drug is part of the class of targeted therapies and is being assessed for its effectiveness in combination with other medications.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504653-12-00Protocol codeCLL-RT1Estimated enrolment107 patientsSponsorUniversity Of Cologne

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