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Long-term Study of Zanubrutinib for Patients with B-cell Blood Cancer

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 the long-term effects of a treatment called Zanubrutinib, also known by its code name BGB-3111. The study is specifically for patients with a type of blood cancer known as B-cell malignancies, which affects the lymph nodes. The purpose of the study is to evaluate the long-term safety of Zanubrutinib regimens in patients who have previously participated in a related study sponsored by the company BeiGene.

Participants in this study will continue to receive Zanubrutinib in the form of capsules taken orally. The study is open-label, meaning both the researchers and participants know what treatment is being administered. The study will take place over an extended period, allowing researchers to gather information on the safety and effects of the treatment over time. Some participants may receive a placebo as part of the study design.

The main focus of the study is to monitor the safety of the treatment by observing any side effects or adverse events that occur. Additionally, researchers will assess how long patients remain free from disease progression, the duration of their response to the treatment, and their overall survival. This information will help determine the long-term benefits and risks of using Zanubrutinib for treating B-cell malignancies.

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

    Joining the study

    Participation in this study requires previous involvement in a related study sponsored by BeiGene. Eligibility is determined by the investigator based on the potential benefit and tolerance of the medication zanubrutinib.

  2. Step 2

    Medication administration

    The medication used in this study is zanubrutinib, which is taken orally in the form of a capsule. The dosage and frequency will be determined by the healthcare provider based on individual needs and response to treatment.

  3. Step 3

    Monitoring and assessments

    Regular monitoring will be conducted to assess the safety of zanubrutinib. This includes tracking any side effects or adverse events that may occur during the study period.

    The study aims to evaluate the long-term safety of zanubrutinib in patients with B-cell malignancies.

  4. Step 4

    Study duration

    The study is expected to continue until June 30, 2027. Participation duration may vary depending on individual circumstances and the investigator's assessment.

  5. Step 5

    Outcome measures

    The primary focus is on safety, assessed by the occurrence of any side effects. Secondary outcomes include progression-free survival, duration of response, and overall survival.

Who can join the trial?

8 criteria

  • The patient must have a type of cancer called B-cell malignancies.
  • The patient must have been part of a previous study sponsored by BeiGene, either currently participating or having participated recently.
  • The patient should intend to continue or start treatment with a drug called zanubrutinib after certain events, such as the end of the previous study or if the disease progresses.
  • If the disease progresses while on zanubrutinib, the patient and doctor must agree that continuing the treatment is in the patient's best interest, even if it's not the standard approach.
  • The patient must be able to tolerate zanubrutinib, meaning they can handle the treatment without needing to stop it permanently.
  • The patient must be within the age range specified for the study.
  • Both male and female patients are eligible to participate.
  • The study may include individuals considered part of a vulnerable population.

Who cannot join the trial?

5 criteria

  • Patients who have not participated in a previous BeiGene study for the medication called zanubrutinib.
  • Patients who do not have a type of cancer called B-cell malignancies. This refers to cancers that affect a specific type of white blood cell known as B-cells.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Zanubrutinib (BGB-3111) is a medication used in the treatment of B-cell malignancies, which are types of blood cancers affecting B lymphocytes. This medication works by blocking a specific protein that helps cancer cells grow and survive. The trial aims to evaluate the long-term safety of zanubrutinib in patients who have already participated in a previous study involving this medication.

What is already known about the treatment

Zanubrutinib – Zanubrutinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its long-term safety in treating B-cell malignancies. The main therapeutic indication for zanubrutinib is the treatment of various B-cell cancers. At the molecular level, it works by inhibiting Bruton's tyrosine kinase (BTK), which plays a crucial role in the growth and survival of B-cells. Zanubrutinib is classified as a BTK inhibitor in pharmacology.

Investigated diseases

B-cell malignancies – B-cell malignancies are a group of cancers that affect B lymphocytes, which are a type of white blood cell responsible for producing antibodies. These malignancies can include various types of lymphomas and leukemias. The disease often begins in the lymph nodes and can spread to other parts of the body, including the bone marrow and spleen. As the disease progresses, it may lead to symptoms such as swollen lymph nodes, fatigue, fever, and weight loss. The progression can vary significantly depending on the specific type of B-cell malignancy.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511267-28-00Protocol codeBGB-3111-LTE1Estimated enrolment787 patientsSponsorBeOne Medicines AG

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