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Study of Ibrutinib and Rituximab for Patients with Follicular Lymphoma

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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 type of cancer called Follicular Lymphoma. Follicular Lymphoma is a slow-growing form of non-Hodgkin lymphoma, which is a cancer that affects the lymphatic system, a part of the immune system. The study is investigating the effects of a medication called Ibrutinib, which is taken as a hard capsule by mouth. Ibrutinib is being tested in combination with another medication called Rituximab, which is commonly used to treat this type of cancer. The trial will compare the combination of Ibrutinib and Rituximab to a combination of a placebo and Rituximab.

The purpose of the study is to see if adding Ibrutinib to Rituximab can help patients live longer without their disease getting worse, which is known as progression-free survival. Participants in the study will be randomly assigned to receive either the Ibrutinib and Rituximab combination or the placebo and Rituximab combination. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased.

Throughout the study, participants will receive regular check-ups and monitoring to assess their health and the effects of the treatment. The study will also look at other outcomes, such as the overall response rate, which measures how well the cancer responds to the treatment, and overall survival, which tracks how long participants live after starting the treatment. The trial aims to provide valuable information on whether the addition of Ibrutinib can improve outcomes for patients with Follicular Lymphoma.

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, eligibility is confirmed based on specific criteria such as age, health status, and diagnosis of follicular lymphoma.

    Participants must have a confirmed diagnosis of follicular lymphoma and meet other health-related criteria.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving ibrutinib with rituximab, and the other receiving a placebo with rituximab.

    This process ensures that the study results are unbiased.

  3. Step 3

    Treatment phase

    Participants in the ibrutinib group take ibrutinib capsules orally. The dosage and frequency are determined by the study protocol.

    Both groups receive rituximab, which is administered according to the study schedule.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the health status and response to treatment.

    Assessments include measuring progression-free survival, overall response rate, and other health indicators.

  5. Step 5

    Completion of treatment

    The treatment phase continues until the study's end date or until specific health criteria are met.

    Participants are monitored for any adverse effects and overall health outcomes.

  6. Step 6

    Follow-up

    After completing the treatment phase, follow-up assessments are conducted to evaluate long-term health outcomes.

    This phase helps in understanding the duration of response and overall survival rates.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of **follicular lymphoma**. This is a type of cancer that affects the lymphatic system. The cancer must be CD20+ and classified as Grade 1, 2, or 3a, and be in Ann Arbor Stage II, III, or IV.
  • Must have a **measurable disease**, meaning the cancer can be measured in size using medical imaging.
  • Must be 70 years of age or older, or between 60-69 years old with one or more other health conditions.
  • Must meet one or more **GELF criteria**, which are specific guidelines used to assess the severity of follicular lymphoma.
  • Must have adequate **hematologic function**, meaning the blood cells are functioning properly, as defined by the study's guidelines.
  • Must have adequate **hepatic and renal function**, meaning the liver and kidneys are working well, as defined by the study's guidelines.
  • Must have an **ECOG performance status score** of 0-2. This score measures how well a person can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • Must not be incarcerated and must be able to willingly provide informed consent, meaning they understand the study and agree to participate. This includes adults who are not under legal protection or unable to express their consent.

Who cannot join the trial?

4 criteria

  • Patients who have previously received treatment for **Follicular Lymphoma** cannot participate. **Follicular Lymphoma** is a type of cancer that affects the lymphatic system.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who have any other medical conditions or factors that the study team believes would make it unsafe or inappropriate for them to participate cannot join the study.
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Investigated drugs

  • Ibrutinib

    is a medication used in this trial as a Bruton’s Tyrosine Kinase (BTK) inhibitor. It is being tested to see if it can help prolong the time patients live without their follicular lymphoma getting worse. It is used in combination with another medication to see if it provides better results than using the other medication alone.

  • Rituximab

    is a medication used to treat certain types of cancer, including follicular lymphoma. In this trial, it is used as a standard treatment to see if adding another medication can improve its effectiveness in preventing the progression of the disease.

What is already known about the treatment

  • Ibrutinib

    This medication is taken orally and is currently being studied in clinical trials for its effectiveness in treating follicular lymphoma. It is a Bruton’s tyrosine kinase (BTK) inhibitor, which means it works by blocking a specific protein that helps cancer cells grow and survive. Ibrutinib is classified as a targeted therapy, and its main therapeutic use is in the treatment of certain types of blood cancers. The goal of the ongoing research is to determine if combining ibrutinib with rituximab can improve patient outcomes compared to using rituximab alone.

  • Rituximab

    Administered through intravenous infusion, rituximab is a well-established medication used in the treatment of follicular lymphoma and other types of blood cancers. It is a monoclonal antibody that targets a specific protein on the surface of cancer cells, leading to their destruction. Rituximab is classified as an immunotherapy, and it works by helping the immune system recognize and attack cancer cells. The current clinical trial is investigating whether adding ibrutinib to rituximab therapy can enhance its effectiveness in prolonging progression-free survival in patients.

Investigated diseases

Follicular Lymphoma – Follicular lymphoma is a type of non-Hodgkin lymphoma that typically grows slowly and affects the lymphatic system. It originates from B-lymphocytes, a type of white blood cell, and often presents as painless swelling in the lymph nodes. Over time, the disease can spread to other parts of the body, including the bone marrow and spleen. Patients may experience symptoms such as fatigue, night sweats, and weight loss. The progression of follicular lymphoma can vary, with some individuals experiencing long periods without symptoms. It is considered a chronic condition that may require ongoing monitoring and management.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507271-21-00Protocol codePCYC-1141-CAEstimated enrolment446 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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