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Long-Term Access to Ibrutinib for Patients with Lymphoma, Leukemia, and Other Conditions

Fast replyInvestigationalNo 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 providing extended treatment with ibrutinib for individuals who have previously participated in ibrutinib clinical trials and continue to benefit from its use. Ibrutinib is a medication used in the treatment of various conditions, including Follicular Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom Macroglobulinemia, Multiple Myeloma, Marginal Zone Lymphoma, Diffuse Large B-Cell Lymphoma, Urothelial Carcinoma, Breast Cancer, Acute Myeloid Leukemia, Graft vs Host Disease, and Mantle Cell Lymphoma. The purpose of this study is to allow patients who have shown positive results from previous trials to continue receiving ibrutinib, even if it is not commercially available in their region.

Participants in this study will continue taking ibrutinib in the form of a hard capsule, which is taken orally. The study will monitor the long-term effects of ibrutinib and any potential side effects that may arise. Patients will be observed for any serious adverse events, which are significant health issues that may occur during the treatment. The study aims to ensure that patients who benefit from ibrutinib can maintain their treatment regimen and continue to manage their condition effectively.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation in an eligible ibrutinib clinical trial is required. Continued benefit from ibrutinib treatment or restarting treatment is necessary, as determined by the treating physician.

    Access to commercial ibrutinib must not be available or reasonably accessible in the region.

    Completion of all assessments in the previous study is required, along with a desire to continue treatment with ibrutinib.

    Signing an informed consent form approved by an independent ethics committee or institutional review board is necessary.

  2. Step 2

    Treatment with ibrutinib

    Ibrutinib is administered in the form of a hard capsule for oral use.

    The treatment involves ongoing continuous administration of ibrutinib. The specific dosage and frequency are determined by the treating physician based on individual needs and previous study protocols.

  3. Step 3

    Safety and monitoring

    Monitoring for any treatment-emergent serious adverse events and adverse events of special interest is conducted, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Regular assessments are performed to ensure the safety and effectiveness of the treatment.

  4. Step 4

    End of study

    The estimated end date for the study is May 10, 2027.

    Continued participation is based on the ongoing benefit from the treatment and the absence of any significant adverse effects.

Who can join the trial?

8 criteria

  • The patient must have participated in a previous clinical trial involving ibrutinib, which is a medication used to treat certain types of cancer.
  • The patient should benefit from continuing or restarting treatment with ibrutinib, according to their doctor's opinion.
  • The patient does not have access to ibrutinib in their region, or it is not easily available to them.
  • The patient must be currently receiving continuous treatment with ibrutinib.
  • The patient must have completed all necessary evaluations in their previous study and wish to continue treatment with ibrutinib.
  • The patient or their legal representative must willingly sign a consent form approved by an independent ethics committee or review board, agreeing to the long-term treatment extension.
  • The patient must not have withdrawn their consent from the previous study.
  • Both male and female patients who can have children must agree to use a highly effective birth control method and a barrier method during treatment and for 90 days after the last dose.

Who cannot join the trial?

5 criteria

  • Patients with certain types of cancer, such as Follicular Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom macroglobulinemia, Multiple Myeloma, Marginal Zone Lymphoma, Diffuse Large B-Cell Lymphoma, Urothelial Carcinoma, Breast Cancer, Acute Myeloid Leukemia, Graft vs Host Disease, and Mantle Cell Lymphoma, may not be eligible.
  • Patients who do not meet the age requirements for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not eligible for long-term access to the study medication, ibrutinib, or the drug combinations from the parent study.
  • Patients who are considered part of a vulnerable population, which means they may need special protection or care.
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Investigated drugs

Ibrutinib is a medication used in this clinical trial to provide long-term treatment for patients who have previously benefited from it in earlier studies. It is designed to help manage certain types of blood cancers by interfering with the growth and spread of cancer cells. This trial aims to continue offering ibrutinib to patients who have shown positive results and meet specific criteria.

What is already known about the treatment

Ibrutinib – Ibrutinib is administered orally in the form of capsules or tablets. It is currently well-established in medical literature and is used in the treatment of various types of cancers, including follicular lymphoma, chronic lymphocytic leukemia, and multiple myeloma, among others. The medication works by inhibiting a specific protein called Bruton's tyrosine kinase (BTK), which plays a crucial role in the survival and spread of cancer cells. Ibrutinib is classified as a targeted therapy, specifically a BTK inhibitor, and is used to manage certain blood cancers and related conditions.

Investigated diseases

Follicular Lymphoma – A type of non-Hodgkin lymphoma that usually grows slowly and affects the lymph nodes. It often presents with painless swelling of lymph nodes and can spread to other parts of the body over time. Chronic Lymphocytic Leukemia – A cancer of the blood and bone marrow that typically progresses slowly. It is characterized by an increase in white blood cells called lymphocytes, which can lead to symptoms like fatigue and swollen lymph nodes. Waldenstrom Macroglobulinemia – A rare type of cancer that begins in the white blood cells and is characterized by the overproduction of a protein called immunoglobulin M. This can lead to symptoms such as bleeding, vision problems, and neurological issues. Multiple Myeloma – A cancer of plasma cells in the bone marrow, leading to bone pain, anemia, and kidney dysfunction. It often progresses with the accumulation of abnormal cells in the bone marrow. Marginal Zone Lymphoma – A type of slow-growing non-Hodgkin lymphoma that originates in the marginal zone of lymphoid tissue. It can affect the spleen, lymph nodes, or other organs and may cause symptoms like swelling and fatigue. Diffuse Large B-Cell Lymphoma – A fast-growing type of non-Hodgkin lymphoma that can arise in lymph nodes or outside of them. It often presents with rapidly enlarging masses and can spread quickly to other parts of the body. Urothelial Carcinoma – A cancer that typically occurs in the bladder but can also affect the ureters and kidneys. It is characterized by the abnormal growth of cells in the lining of the urinary tract. Breast Cancer – A common cancer that forms in the cells of the breasts, often presenting as a lump or mass. It can spread to other parts of the body through the lymphatic system or bloodstream. Acute Myeloid Leukemia – A fast-growing cancer of the blood and bone marrow characterized by the rapid production of abnormal white blood cells. It can lead to symptoms such as fatigue, fever, and an increased risk of infections. Graft vs Host Disease – A condition that can occur after a bone marrow or stem cell transplant, where the donated cells attack the recipient's body. It can affect various organs and tissues, leading to a range of symptoms. Mantle Cell Lymphoma – A rare type of non-Hodgkin lymphoma that typically affects older adults and is characterized by the overproduction of B-cells. It often presents with swollen lymph nodes and can spread to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507329-40-00Protocol codePCYC-1145-LTEstimated enrolment620 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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