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Study Comparing Golcadomide and Rituximab with Other Treatments for Patients with Relapsed or Refractory Follicular Lymphoma

Verified siteRegistered drugNo 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 investigating the efficacy and safety of golcadomide in combination with rituximab compared to investigator's choice of treatment in people with relapsed/refractory follicular lymphoma. Follicular lymphoma is a type of blood cancer that affects white blood cells called B lymphocytes. "Relapsed/refractory" means the cancer has returned after treatment or did not respond adequately to previous treatments.

The purpose of this study is to evaluate whether the combination of golcadomide and rituximab is more effective than other treatment options chosen by investigators for patients whose follicular lymphoma has not responded well to previous therapies. During the study, participants will receive either the combination treatment or another treatment selected by their doctor.

The study will track various outcomes including how long participants live without their disease getting worse, overall survival time, how well the cancer responds to treatment, and how the treatment affects quality of life. Participants must be over 18 years of age and meet specific health criteria to join the study.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study Assignment

    You will be randomly assigned to receive either Golcadomide in combination with Rituximab (Golca + R) or an Investigator's Choice treatment for your relapsed/refractory follicular lymphoma (a type of blood cancer that affects the lymphatic system and has returned or not responded to previous treatment).

  2. Step 2

    Treatment Phase

    If assigned to the Golcadomide plus Rituximab group: You will take Golcadomide orally in capsule form, and receive Rituximab, which is given through an intravenous (IV) infusion (directly into your vein).

    If assigned to the Investigator's Choice group: You may receive one of several standard treatments which could include combinations of medications such as bendamustine hydrochloride, cyclophosphamide, lenalidomide, rituximab, betamethasone sodium phosphate, prednisone, doxorubicin hydrochloride, vincristine sulfate, or pegfilgrastim. The specific regimen will be determined by your doctor.

  3. Step 3

    Regular Assessments

    Throughout the study, you will have regular visits to evaluate how your cancer is responding to treatment. These assessments will follow the Lugano 2014 classification guidelines, which are standard criteria for evaluating lymphoma response.

    Assessments will include blood tests, imaging studies, and physical examinations to monitor your cancer and any side effects from treatment.

  4. Step 4

    Quality of Life Evaluations

    You will complete questionnaires about how you feel and how the treatment is affecting your daily life. These help researchers understand the impact of treatment beyond just the medical effects.

  5. Step 5

    Monitoring for Disease Progression

    Your cancer will be regularly monitored to check if it is responding to treatment, staying stable, or progressing (getting worse).

    If your disease progresses, this will be documented as part of the study's primary measurement (progression-free survival).

  6. Step 6

    Follow-up Period

    After completing treatment, you will enter a follow-up period where your health will continue to be monitored.

    The study will track how long you live overall, whether you need to start new treatments, and the long-term outcomes of your cancer response.

  7. Step 7

    Study Completion

    The study is expected to run until July 14, 2025, with final data collection for the primary outcome measure.

    The entire study, including long-term follow-up, is anticipated to continue until November 6, 2027.

Who can join the trial?

5 criteria

  • Must be over 18 years old
  • Must have Relapsed/Refractory Follicular Lymphoma (a type of blood cancer that has returned after treatment or did not respond to previous treatments)
  • Must meet specific disease characteristics required by the study
  • Must have acceptable laboratory values (blood test results) as defined by the study
  • Must meet reproductive capacity requirements (this may include using effective birth control methods during the study if able to have children)

Who cannot join the trial?

11 criteria

  • You have previously received more than two treatments for your follicular lymphoma.
  • You have undergone treatment with obinutuzumab (a type of cancer medication) less than 12 months ago.
  • You have a type of cancer called transformed follicular lymphoma.
  • You have previously received certain treatments including CAR-T cell therapy (a treatment that uses your own immune cells) or golvatinib (the study medication).
  • You have had a stem cell transplant (a procedure to replace damaged bone marrow with healthy cells) within the last 100 days.
  • You have active central nervous system (brain and spinal cord) lymphoma.
  • You have other significant medical conditions that could interfere with the study, such as serious heart problems, infections, or other cancers.
  • You are pregnant or breastfeeding.
  • You cannot use effective contraception during the study period if you are able to have children.
  • You have laboratory test results that show significant abnormalities in your blood counts, liver function, or kidney function.
  • You are currently participating in another clinical trial with an experimental treatment.
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Investigated drugs

  • Golcadomide

    is an experimental medication being studied for the treatment of relapsed or refractory follicular lymphoma (a type of blood cancer that affects the lymphatic system). It is being tested in combination with rituximab to see if it can help patients whose cancer has returned or not responded to previous treatments.

  • Rituximab

    is an approved medication that works by targeting a specific protein (CD20) found on the surface of certain white blood cells called B cells, including the cancerous B cells in follicular lymphoma. It helps the immune system identify and destroy these cancer cells.

What is already known about the treatment

  • Golcadomide

    An investigational oral medication being studied in clinical trials for relapsed/refractory follicular lymphoma, typically administered in combination with rituximab. It belongs to the class of immunomodulatory drugs (IMiDs) that work by targeting the immune system to fight cancer cells, potentially by affecting tumor microenvironment and enhancing immune response against lymphoma cells. Currently in Phase 3 clinical trials (GOLSEEK-4 study), golcadomide is being evaluated for its efficacy and safety compared to investigator's choice treatments in patients whose follicular lymphoma has returned or stopped responding to previous therapies.

  • Rituximab

    A well-established intravenous or subcutaneous monoclonal antibody medication used in the treatment of various B-cell lymphomas, including follicular lymphoma. It works by targeting the CD20 protein found on the surface of B-lymphocytes, marking these cells for destruction by the immune system, which helps eliminate cancerous B-cells. Rituximab is approved by regulatory agencies worldwide and is considered a standard component of many lymphoma treatment regimens, often used in combination with other therapies to improve outcomes for patients with both newly diagnosed and relapsed/refractory follicular lymphoma.

Investigated diseases

Relapsed/Refractory Follicular Lymphoma – A form of non-Hodgkin lymphoma that has returned after initial treatment (relapsed) or has not responded adequately to treatment (refractory). Follicular lymphoma affects the B lymphocytes within the lymphatic system, causing them to abnormally multiply and build up in lymph nodes. The disease typically progresses slowly with enlarged lymph nodes, fatigue, night sweats, and weight loss as common symptoms. As it advances, the lymphoma can spread to other lymph nodes, bone marrow, spleen, and other organs. This disease follows a pattern of remissions and relapses, with each subsequent remission potentially being shorter than the previous one.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519152-82-00Protocol codeCA073-1003Estimated enrolment403 patientsSponsorCelgene Corp.

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