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Study on Radiotherapy Alone or with Obinutuzumab for Patients with Early Stage 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, specifically in its early stages. The trial is investigating the effects of a treatment called Obinutuzumab, which is a type of medication known as a monoclonal antibody. This medication is being tested in combination with local radiotherapy, a treatment that uses high-energy rays to target and kill cancer cells. The study aims to compare the effectiveness of using radiotherapy alone versus using it together with Obinutuzumab.

The purpose of the study is to determine if the combination of radiotherapy and Obinutuzumab can improve the time patients live without the disease getting worse, known as progression-free survival. Participants in the study will be randomly assigned to receive either radiotherapy alone or radiotherapy combined with Obinutuzumab. The study will follow participants over a period to observe the outcomes and gather data on the effectiveness and safety of the treatments.

Throughout the study, participants will receive regular check-ups and monitoring to assess their health and the progress of the treatment. The trial will help researchers understand whether adding Obinutuzumab to radiotherapy provides better results for patients with early-stage Follicular Lymphoma compared to radiotherapy alone. This research could potentially lead to improved treatment options for individuals diagnosed with this type of cancer.

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, the patient will be informed about the trial's objectives and procedures. The patient must sign an informed consent form, indicating understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, a physical examination, and necessary laboratory tests to ensure adequate renal and hepatic function.

    A PET/CT scan will be performed to determine the stage of the disease, and a bone marrow biopsy will be conducted to ensure it is negative.

  3. Step 3

    Randomization

    The patient will be randomly assigned to one of two groups: the standard arm receiving only local radiotherapy or the experimental arm receiving both local radiotherapy and obinutuzumab.

  4. Step 4

    Treatment phase

    For patients in the experimental arm, obinutuzumab will be administered as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

    Both groups will receive local radiotherapy as part of their treatment regimen.

  5. Step 5

    Monitoring and follow-up

    Throughout the treatment phase, the patient will be monitored for response to treatment and any potential side effects. Regular follow-up visits will be scheduled to assess the patient's health status and progression-free survival.

    Additional tests, such as blood tests and imaging studies, may be conducted to evaluate the treatment's effectiveness and monitor for any adverse events.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation will be conducted to determine the patient's response to the treatment. This includes assessing complete response rate, overall response rate, and disease-free survival.

    The study will also evaluate molecular response and any adverse events experienced during the trial.

Who can join the trial?

17 criteria

  • Must have a confirmed diagnosis of **Follicular Lymphoma** grade I-IIIA, which is a type of blood cancer.
  • Must be in **Ann Arbor Stage IA or IIA** or IE, non-bulky, which means the cancer is in an early stage and not large.
  • Must be at least **18 years old**.
  • Must have a **negative bone marrow biopsy**, meaning no cancer cells are found in the bone marrow.
  • Must have a **performance status** of 2 or less, which means being able to carry out daily activities with some limitations.
  • Must have at least one **measurable lymph node** that is 2.0 cm or larger, as seen on a CT scan or ultrasound.
  • Must have **adequate kidney function**, with a creatinine clearance of 40 mL/min or more, which is a measure of how well the kidneys are working.
  • Must have **adequate liver function**, with certain liver enzymes and bilirubin levels within specific limits.
  • Must understand and sign an **informed consent form**, agreeing to participate in the study.
  • Must be able to follow the study schedule and requirements.
  • Must have a **life expectancy** of at least 3 months.
  • Must meet specific **fertility and pregnancy prevention criteria**:
    • Women must be postmenopausal, surgically sterile, abstinent, or using effective birth control.
    • Men must use a condom plus another contraceptive method or practice true abstinence.
    • Must not have had any previous treatment for the lymphoma, except for steroid pre-treatment.
    • Must have a **FLIPI score** of less than 2, which is a way to assess the risk of the lymphoma.
    • Must have a **centralized assessment** of certain cells in the blood and bone marrow.
    • Must have a **centralized review** of the lymph node biopsy with specific genetic testing.

Who cannot join the trial?

4 criteria

  • Patients with medical conditions other than early stage Follicular Lymphoma cannot participate. Follicular Lymphoma is a type of blood cancer that affects the lymphatic system.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.
  • Patients who do not meet other specific health criteria set by the study organizers cannot participate. These criteria are usually related to the patient's overall health and medical history.
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Investigated drugs

Obinutuzumab is a medication used in this trial to treat early-stage Follicular Lymphoma. It is an antibody that targets specific cells in the immune system, helping to slow down or stop the growth of cancer cells. In this study, it is being tested in combination with radiotherapy to see if it improves the time patients live without the disease getting worse, compared to using radiotherapy alone. Radiotherapy is a standard treatment that uses high-energy rays to target and kill cancer cells. In this trial, it is used alone in one group of patients to compare its effectiveness against the combination of radiotherapy and obinutuzumab in treating early-stage Follicular Lymphoma.

What is already known about the treatment

Obinutuzumab – This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating early-stage Follicular Lymphoma, often in combination with radiotherapy. Obinutuzumab is primarily used to target and destroy specific cancer cells in the immune system. It works by binding to a protein called CD20 found on the surface of certain B-cells, leading to their destruction. This medication is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

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. In its early stages, the disease may not cause significant symptoms, and individuals might feel generally well. Over time, the lymphoma can spread to other parts of the body, including the bone marrow and spleen. As it progresses, symptoms such as fatigue, night sweats, and weight loss may develop. The disease is characterized by periods of remission and relapse, with the potential for transformation into a more aggressive form.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502775-29-01Estimated enrolment190 patientsSponsorFondazione Italiana Linfomi Ets

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