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Study on Early Stage Follicular Lymphoma: Evaluating Radiotherapy with Rituximab or Obinutuzumab for Patients with Early Stage Nodal 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 Early Stage Follicular Lymphoma. The trial is exploring the effectiveness of two different treatments. One treatment involves a medication called Rituximab, which is a type of protein that helps the immune system target cancer cells. The other treatment uses a medication known as Obinutuzumab, which is also a protein designed to help the immune system fight cancer. Both medications are given through a process called an infusion, where the medicine is slowly introduced into the body through a vein.

The purpose of the study is to evaluate how well these treatments work when combined with a type of cancer treatment called radiotherapy, which uses high-energy rays to target and kill cancer cells. The study will compare the effects of standard-dose radiotherapy combined with Rituximab to low-dose radiotherapy combined with Obinutuzumab. Participants in the study will receive one of these treatment combinations, and their progress will be monitored over a period of time to see how the cancer responds.

Throughout the study, participants will undergo regular check-ups and imaging tests, such as CT scans, to assess the size and activity of the lymphoma. The study aims to determine which treatment combination is more effective in achieving a complete response, meaning the cancer is no longer detectable. The trial will also look at other factors, such as the side effects of the treatments and the overall quality of life of the participants during and after 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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, stage of lymphoma, and overall health status.

    Written informed consent is required to participate in the trial.

  2. Step 2

    Initial assessment

    An initial diagnostic biopsy is performed to confirm the presence of CD20-positive follicular lymphoma.

    Imaging tests such as CT or MRI are conducted to assess the size and location of the lymphoma.

  3. Step 3

    Treatment phase 1

    The first phase of treatment involves radiotherapy. Two options are available: a standard dose of 24 Gy or a low dose of 4 Gy.

    The choice of radiotherapy dose is determined by the study protocol and the specific characteristics of the lymphoma.

  4. Step 4

    Medication administration

    Alongside radiotherapy, an anti-CD20 antibody is administered. This involves either Rituximab or Obinutuzumab.

    Both medications are given as a solution for infusion through an intravenous line.

  5. Step 5

    Evaluation at week 18

    At week 18, a morphologic complete response (CR) is evaluated using imaging tests to determine the effectiveness of the treatment.

    The response is assessed by checking for any remaining lymphoma.

  6. Step 6

    Follow-up assessments

    Further assessments occur at week 7 and month 6 to monitor the response to treatment.

    These assessments include checking for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).

  7. Step 7

    Long-term follow-up

    Progression-free survival and overall survival are monitored for up to two years after the start of individual treatment.

    Quality of life is assessed using specific questionnaires at various intervals, including week 18, month 12, and month 24.

Who can join the trial?

10 criteria

  • The patient must have a type of lymphoma called **CD20-positive follicular lymphoma** grade 1/2 or 3a, confirmed by a central review.
  • Both men and women who can have children must use **adequate contraception** during the treatment and for 18 months after.
  • The lymphoma must be **untreated**, meaning the patient has not received radiation, chemotherapy, or immunotherapy for it.
  • The patient must be **18 years or older**.
  • The patient must have an **ECOG score** of 0-2, which is a scale that measures how well a patient can perform daily activities.
  • The lymphoma must be in **clinical stage I or II**, determined by a special scan called **FDG-PET**.
  • The largest part of the lymphoma must be **7 cm or smaller** in diameter, as seen in sectional images.
  • The patient must provide **written informed consent** and be willing to cooperate during the trial.
  • The patient must have **adequate bone marrow capacity**, which means certain blood counts must be at specific levels: ANC (a type of white blood cell) must be 1.5 x 103/ml or higher, platelets must be 100,000 x 103/ml or higher, and hemoglobin must be 10 g/dL or higher.
  • The patient must be able to **understand the purpose and consequences** of the clinical trial.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than early stage follicular lymphoma cannot participate. Follicular lymphoma is a type of blood cancer that affects the lymph nodes.
  • 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 not able to give informed consent, meaning they cannot understand the study and agree to participate, are excluded.
  • Patients who have other serious health conditions that might interfere with the study treatment or outcomes are not eligible.
  • Patients who are pregnant or breastfeeding cannot participate, as the study treatments might affect the baby.
  • Patients who have received certain treatments for their lymphoma before, which might affect the study results, are excluded.
  • Patients who are participating in another clinical trial at the same time are not eligible.
  • Patients who have allergies or reactions to the study medications, such as Rituximab or Obinutuzumab, cannot participate. These are medications used to treat certain types of cancer.
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Investigated drugs

  • Rituximab

    is a medication used in this trial to treat early-stage nodal follicular lymphoma. It is an anti-CD20 antibody that helps the immune system target and destroy certain cancer cells. In this study, Rituximab is combined with standard-dose radiotherapy to evaluate its effectiveness in achieving a complete response in patients.

  • Obinutuzumab

    is another anti-CD20 antibody used in this trial. It works similarly to Rituximab by helping the immune system attack cancer cells. In this study, Obinutuzumab is combined with low-dose radiotherapy to assess its potential in treating early-stage nodal follicular lymphoma.

What is already known about the treatment

  • Rituximab

    This medication is administered intravenously and is used in the treatment of certain types of cancer, including early-stage follicular lymphoma. It is currently well-established in medical practice and literature as an effective treatment option. Rituximab works by targeting the CD20 protein found on the surface of B-cells, leading to their destruction. It is classified as a monoclonal antibody and is primarily used for its ability to help the immune system attack cancer cells.

  • Obinutuzumab

    This medication is also administered intravenously and is used in the treatment of early-stage follicular lymphoma. It is recognized in medical literature as a newer option compared to Rituximab. Obinutuzumab targets the CD20 protein on B-cells, similar to Rituximab, but is engineered to enhance the immune system's ability to destroy these cells. It is classified as a monoclonal antibody and is used to improve treatment outcomes in combination with radiotherapy.

Investigated diseases

Follicular Lymphoma – Follicular lymphoma is a type of non-Hodgkin lymphoma that typically affects the lymph nodes. It is characterized by the slow growth of cancerous B-cells, which are a type of white blood cell. In the early stages, it may not cause noticeable symptoms, but as it progresses, it can lead to swollen lymph nodes, fatigue, and night sweats. The disease often follows a pattern of periods of remission and relapse. Over time, it can transform into a more aggressive form of lymphoma. The progression of follicular lymphoma can vary greatly among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509278-41-00Protocol codeFORTplusEstimated enrolment145 patientsSponsorUniversitaetsklinikum Heidelberg AöR

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