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Long-term Study of Ibrutinib for Patients with B-cell Non-Hodgkin's Lymphoma and Chronic Graft Versus Host Disease

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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 medication called ibrutinib, which is used to treat certain types of blood cancers, specifically B-cell non-Hodgkin's lymphoma and a condition known as chronic graft-versus-host disease (cGVHD). The purpose of the study is to gather information on the safety and effectiveness of ibrutinib over an extended period and to continue providing the medication to participants who are already benefiting from it in previous studies.

Participants in this study will continue to receive ibrutinib, which is taken in the form of a capsule. The study will monitor the participants' health and any changes in their condition while they are on the medication. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects. The study aims to ensure that ibrutinib remains safe and effective for those who have been using it and to understand its long-term impact on their health.

The study will take place over several years, allowing researchers to collect comprehensive data on the long-term use of ibrutinib. Participants will be regularly assessed to track any side effects or changes in their disease status. This information will help in understanding how ibrutinib can be used most effectively in treating these conditions and ensuring the well-being of those who rely on it for their treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, ensure that you have been actively participating in a previous ibrutinib clinical study that is now considered complete.

    You must have received at least 6 months of treatment with ibrutinib or be transitioning from a comparator treatment to ibrutinib.

    A negative blood or urine pregnancy test is required at the start of the study.

  2. Step 2

    Treatment with ibrutinib

    Continue receiving ibrutinib treatment, which is administered orally in the form of a 140 mg capsule.

    The frequency and duration of the treatment will be determined by the study protocol and your healthcare provider.

  3. Step 3

    Monitoring and assessments

    Regular monitoring will be conducted to assess the safety and efficacy of the treatment.

    Initial safety assessments may be more frequent if you have received less than 6 months of prior ibrutinib treatment.

  4. Step 4

    Adverse event reporting

    Any adverse events experienced during the study will be documented and analyzed.

    The primary endpoint of the study is to record the number of participants affected by an adverse event.

  5. Step 5

    Evaluation of disease status

    The study will also evaluate changes in your disease status as a secondary endpoint.

    This involves regular assessments to determine the effectiveness of the treatment.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by December 31, 2026.

    Upon completion, further instructions will be provided regarding ongoing treatment and follow-up care.

Who can join the trial?

5 criteria

  • Participants must be currently involved in a clinical study with a medicine called ibrutinib that is considered completed. They should have received at least 6 months of treatment with ibrutinib.
  • At the start of the study, participants must be actively receiving treatment with ibrutinib alone.
  • Alternatively, participants must have been part of a study where they initially received a different treatment and are now switching to ibrutinib. In this case, the 6-month treatment requirement is not necessary, but they will need more frequent safety checks if they have had less than 6 months of ibrutinib treatment.
  • Participants must agree to use effective birth control methods as defined by the study.
  • Participants must have a negative pregnancy test, either from blood or urine, at the start of the study.

Who cannot join the trial?

3 criteria

  • Patients who are not currently enrolled in ibrutinib studies that have been completed.
  • Patients who are not actively receiving treatment with ibrutinib.
  • Patients who do not continue to benefit from ibrutinib treatment.
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Investigated drugs

Ibrutinib is a medication used in this clinical trial. It is designed to help treat certain types of blood cancers by blocking a specific protein that helps cancer cells grow and divide. The trial aims to gather long-term safety and effectiveness data for patients who have been receiving this medication and continue to benefit from it.

What is already known about the treatment

Ibrutinib – This medication is taken orally and is used primarily for treating B-cell non-Hodgkin's lymphoma and chronic graft-versus-host disease (cGVHD). It is currently well-documented in medical literature and is undergoing long-term studies to assess its safety and effectiveness. Ibrutinib works by inhibiting a specific protein called Bruton's tyrosine kinase, which plays a crucial role in the survival and spread of cancer cells. It is classified as a targeted therapy, specifically a kinase inhibitor, and is designed to interfere with the growth of cancer cells.

Investigated diseases

  • B-cell non-Hodgkin's lymphoma

    This is a type of cancer that originates in the lymphatic system, specifically affecting B-lymphocytes, which are a type of white blood cell. It typically presents as painless swelling of lymph nodes, but can also affect other organs. The disease can progress at varying rates, with some forms being slow-growing and others more aggressive. As it advances, it may lead to symptoms such as fever, night sweats, and unexplained weight loss. The progression can involve the spread of cancerous cells to other parts of the body, including the bone marrow and spleen.

  • Chronic graft-versus-host disease (cGVHD)

    This condition occurs when donor cells attack the recipient's body following a stem cell or bone marrow transplant. It can affect multiple organs, including the skin, liver, and digestive tract. Symptoms may include skin rashes, dry mouth, and liver dysfunction. The disease can develop months after the transplant and may persist for a long time. It often leads to chronic inflammation and tissue damage in the affected areas. The progression can vary widely, with some individuals experiencing mild symptoms and others facing more severe complications.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503803-27-00Protocol codePCI-32765CAN3001Estimated enrolment208 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

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