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Study on Rituximab, Lenalidomide, and Tafasitamab for Treating High-Risk and Low-Risk Follicular Lymphoma Patients

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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 the treatment of follicular lymphoma, a type of blood cancer that affects the lymphatic system. The study involves three medications: rituximab, lenalidomide, and tafasitamab. Rituximab and tafasitamab are given as solutions through a vein, while lenalidomide is taken as a capsule by mouth. The purpose of the study is to evaluate how effective the addition of tafasitamab is when combined with rituximab and lenalidomide in treating follicular lymphoma.

Participants in the study will be divided into groups based on their risk level. Those with high-risk disease will receive all three medications: rituximab, lenalidomide, and tafasitamab. Those with low-risk disease will receive rituximab and lenalidomide, with a chance of also receiving tafasitamab. The study will follow participants over a period to observe the effects of these treatments on their condition.

The trial aims to understand how these medications work together to treat follicular lymphoma and to monitor any side effects that may occur. The study will also look at how long the treatment effects last and how they impact the overall health and quality of life of the participants. This research is important for developing better treatment strategies for people with follicular lymphoma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment begins with the administration of rituximab, lenalidomide, and tafasitamab for patients with high-risk follicular lymphoma. For those with low-risk disease, treatment includes rituximab and lenalidomide, with a random assignment to receive tafasitamab or not.

    Rituximab is given through an intravenous infusion. Lenalidomide is taken orally. Tafasitamab is administered via intravenous infusion as well.

  2. Step 2

    Medication schedule

    The specific dosage and frequency of each medication are determined by the study protocol and the patient's individual response to treatment. The duration of administration is based on the patient's progress and the study's guidelines.

  3. Step 3

    Monitoring and assessment

    Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes physical examinations, blood tests, and imaging studies as needed.

    The primary goal is to evaluate the addition of tafasitamab to the treatment regimen and its impact on the progression of follicular lymphoma.

  4. Step 4

    Follow-up phase

    After the initial treatment phase, follow-up visits are scheduled to monitor the patient's health and any long-term effects of the treatment.

    The follow-up period includes assessments of disease progression, overall survival, and quality of life.

Who can join the trial?

15 criteria

  • Provide a signed agreement to participate, following international guidelines for clinical trials.
  • Be between the ages of 18 and 85 years old.
  • Have a confirmed diagnosis of **follicular lymphoma** (a type of blood cancer) that is not suitable for radiation treatment. The diagnosis should be confirmed through a tissue sample, preferably from surgery.
  • Have at least one tumor that can be measured in two directions, with the longest side being more than 15 mm.
  • Have a **WHO performance status** of 0 to 2, which means you are fully active or have some limitations but can still take care of yourself.
  • Have at least one reason for needing treatment, such as:
    • Having symptoms from the disease.
    • Pressure on important organs or blood vessels.
    • Fluid buildup in the abdomen or around the lungs.
    • A large tumor (6 cm or more).
    • Significant tumor growth over at least 3 months.
    • **B-symptoms**, which include losing more than 10% of body weight in 6 months, heavy night sweats, or fever over 38°C not caused by an infection.
    • Low red blood cell count (**anemia**) or low platelet count (**thrombocytopenia**) due to lymphoma.
    • Women who can become pregnant must:
      • Have a negative result on a sensitive pregnancy test.
      • Use a highly effective birth control method during the study and for a specific time after the last dose of each study drug.
      • Men who are sexually active must agree to use a condom during treatment and for a week after the last dose to prevent exposure of the study drugs to embryos or fetuses.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer other than follicular lymphoma cannot participate. Follicular lymphoma is a type of blood cancer that affects the lymphatic system.
  • Patients who are not in the age range specified for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had certain treatments for cancer recently may not be eligible to participate.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.
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Investigated drugs

  • Rituximab

    is a medication used to treat certain types of cancer, including follicular lymphoma. It works by targeting specific proteins on the surface of cancer cells, helping the immune system to destroy them.

  • Lenalidomide

    is a drug that helps the immune system fight cancer. It is used in combination with other medications to treat follicular lymphoma by slowing or stopping the growth of cancer cells.

  • Tafasitamab

    is a medication that is being studied for its effectiveness in treating follicular lymphoma. It works by binding to cancer cells and helping the immune system to attack and destroy them.

What is already known about the treatment

  • Rituximab

    This medication is administered intravenously and is currently well-established in medical practice and literature. It is primarily used to treat certain types of cancer, including follicular lymphoma. Rituximab works by targeting a specific protein on the surface of cancer cells, leading to their destruction. It is classified as a monoclonal antibody.

  • Lenalidomide

    This medication is taken orally and is widely recognized in medical literature. It is used to treat various blood cancers, including follicular lymphoma. Lenalidomide modulates the immune system and inhibits the growth of cancer cells. It belongs to a class of drugs known as immunomodulatory agents.

  • Tafasitamab

    Administered intravenously, tafasitamab is currently being studied in clinical trials for its effectiveness in treating follicular lymphoma. It is designed to bind to a specific protein on cancer cells, promoting their destruction by the immune system. Tafasitamab is classified as a monoclonal antibody.

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 of lymph nodes. The disease can spread to other parts of the body, including the bone marrow and spleen. Over time, follicular lymphoma may transform into a more aggressive form of lymphoma. Symptoms can include fatigue, night sweats, and unexplained weight loss. The progression of the disease varies, with some individuals experiencing long periods without symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508196-36-00Estimated enrolment270 patientsSponsorKarolinska University Hospital

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).