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Study on the Effectiveness and Safety of Golcadomide and Rituximab for Patients with Newly Diagnosed Advanced 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 focused on studying a type of cancer called Follicular Lymphoma, which is a form of non-Hodgkin lymphoma. The study involves patients who have been newly diagnosed with advanced stages of this disease. The treatment being tested combines two medications: Golcadomide and Rituximab. Golcadomide, also known by its code name CC-99282, is taken orally in capsule form, while Rituximab is administered as an infusion, meaning it is given directly into the bloodstream through a vein.

The purpose of the study is to evaluate the effectiveness and safety of this combination treatment. The main goal is to see if the treatment can achieve a Complete Metabolic Response (CMR), which means that after treatment, tests show no signs of cancer in the body. The study will also monitor for any side effects or adverse events, which are any negative impacts on health that occur during the treatment. These include any new side effects that appear after starting the treatment, known as Treatment-Emergent Adverse Events (TEAEs).

Participants in the study will receive the treatment over a period of time, and their response will be evaluated at different stages, such as 6 months and 12 months after starting the treatment. The study will also assess the overall response rate (ORR), which is the percentage of participants whose cancer shrinks or disappears, as well as progression-free survival (PFS) and overall survival (OS). PFS is the time from the start of treatment until the disease worsens or the patient passes away, while OS is the time from the start of treatment until the patient passes away. The study aims to provide valuable information on the potential benefits and risks of using Golcadomide and Rituximab together for treating advanced stage Follicular Lymphoma.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on age and specific health criteria related to follicular lymphoma.

  2. Step 2

    Initial treatment phase

    The treatment begins with the administration of rituximab and golcadomide. Rituximab is given intravenously, which means it is delivered directly into a vein. Golcadomide is taken orally in capsule form.

  3. Step 3

    Combination therapy

    Additional medications are introduced, including vincristine sulfate, pegfilgrastim, bendamustine hydrochloride, cyclophosphamide monohydrate, prednisone, and doxorubicin hydrochloride. These are administered either intravenously or orally, depending on the specific drug.

  4. Step 4

    Monitoring and assessment

    Throughout the treatment, regular assessments are conducted to evaluate the Complete Metabolic Response (CMR), which checks for the absence of cancer signs in the body. This includes tests at intervals such as 6 months and 12 months after starting treatment.

  5. Step 5

    Evaluation of side effects

    The study monitors for any negative side effects or adverse events, known as Treatment-Emergent Adverse Events (TEAEs). This involves tracking any new side effects that occur after treatment begins.

  6. Step 6

    Response rate and survival analysis

    The overall response rate (ORR) is evaluated, which measures the percentage of participants whose cancer shrinks or disappears. Additionally, progression-free survival (PFS) and overall survival (OS) are assessed to determine the time until the disease worsens or the patient passes away.

  7. Step 7

    Completion of study

    The study is estimated to conclude by November 15, 2028. Final assessments will be conducted to determine the long-term efficacy and safety of the treatment.

Who can join the trial?

7 criteria

  • Participants must be over the age of 18.
  • Participants must have been newly diagnosed with **Advanced Stage Follicular Lymphoma**. This is a type of cancer that affects the lymphatic system, which is part of the body's immune system.
  • Participants must meet all the necessary criteria related to their disease characteristics. This means their specific type and stage of cancer must match what the study is looking for.
  • Participants must have certain laboratory values. These are results from blood tests or other medical tests that show the current state of their health.
  • Participants must meet criteria related to **reproductive capacity status**. This refers to whether they can have children or not, which might be important for the study.
  • Both male and female participants are eligible to join the study.
  • The study does not include vulnerable populations. This means people who might need special protection or care are not part of this study.

Who cannot join the trial?

5 criteria

  • Patients who have not been diagnosed with Newly Diagnosed Advanced Stage Follicular Lymphoma cannot participate. This is a type of cancer that affects the lymphatic system, which is part of the body's immune 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 belong to a clinical trial group that is not included in this study cannot participate. Clinical trial groups are categories used to organize participants based on specific characteristics.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are considered part of a vulnerable population are not excluded from this study. Vulnerable populations include groups that may need special protection or care.
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Investigated drugs

  • Golcadomide

    is a medication being studied for its potential to help treat advanced stage follicular lymphoma, a type of cancer. In this trial, it is used in combination with another medication to see if it can help eliminate signs of cancer in the body.

  • Rituximab

    is a medication that is commonly used to treat certain types of cancer, including follicular lymphoma. It works by targeting specific cells in the immune system that contribute to the growth of cancer. In this study, it is combined with Golcadomide to evaluate their effectiveness together in treating the disease.

What is already known about the treatment

  • Golcadomide

    Golcadomide is administered orally and is currently being studied in clinical trials for its effectiveness in treating newly diagnosed advanced stage follicular lymphoma. It is not yet widely used in medical practice, as it is still under investigation. The main therapeutic indication for Golcadomide is to achieve a complete metabolic response in patients, meaning the cancer shows no signs in the body after treatment. At the molecular level, Golcadomide works by interfering with specific pathways that cancer cells use to grow and survive, classifying it as an antineoplastic agent.

  • Rituximab

    Rituximab is administered through intravenous infusion and is an established medication used in the treatment of various types of lymphoma, including follicular lymphoma. It is well-documented in medical literature and widely used in clinical practice. The main therapeutic indication for Rituximab is to target and destroy specific cancer cells, particularly those expressing the CD20 protein. Its mechanism of action involves binding to the CD20 protein on the surface of B-cells, leading to their destruction, and it is classified as a monoclonal antibody.

Investigated diseases

Follicular Lymphoma – Follicular lymphoma is a type of non-Hodgkin lymphoma, which is a cancer that starts in the white blood cells called lymphocytes. It typically progresses slowly and is often diagnosed at an advanced stage. The disease is characterized by the formation of tumors in the lymph nodes, spleen, or other organs. As it advances, it can cause symptoms such as swollen lymph nodes, fatigue, and weight loss. The progression of follicular lymphoma can vary, with periods of stability followed by periods of growth. It is considered a chronic condition that may require ongoing monitoring and management.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511304-16-00Protocol codeCA073-1022Estimated enrolment150 patientsSponsorCelgene Corp.

sourced from the EU Clinical Trials Register and site verification

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