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Study of Obinutuzumab as First-Line Treatment for Adult Patients with Marginal Zone Lymphoma Who Are Not Eligible for Local Therapy

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

The study focuses on patients with Marginal Zone Lymphoma (MZL), a type of blood cancer that affects specific areas of the lymphatic system. The research will test a medication called obinutuzumab (Gazyvaro), which is given through an intravenous infusion directly into the bloodstream.

The purpose of this research is to evaluate how well obinutuzumab works and what side effects it may cause when used as a first treatment for people with MZL who cannot receive local treatments or for whom local treatments have not worked. The medication will be given as a single treatment, meaning it will not be combined with other cancer medications.

During the study, participants will receive obinutuzumab through an intravenous infusion at a dose of 1,000 mg. The treatment period may last up to 30 months. Throughout the study, doctors will monitor the participants' response to treatment and track any side effects that may occur. The study will also look at how the treatment affects participants' quality of life and whether any other health conditions develop over time.

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 obinutuzumab (Gazyvaro), which is given through an intravenous infusion

    The medication is administered as a 1,000 mg solution for infusion

    This phase is called the induction therapy period

  2. Step 2

    Response evaluation

    Your response to treatment will be evaluated 4 weeks after completing the initial treatment phase

    The doctor will check if there has been a complete response or partial response to the treatment

    Medical imaging tests will be performed to measure the results

  3. Step 3

    Ongoing monitoring

    Regular check-ups will continue throughout the study period

    Your quality of life will be assessed using a questionnaire called FACTLym

    The doctor will monitor for any changes in your condition and any side effects

  4. Step 4

    Long-term follow-up

    The study continues with regular monitoring until 2029

    The doctor will track your progress and any changes in your condition

    Additional medical tests may be performed as needed to evaluate your health status

Who can join the trial?

14 criteria

  • Age 18 years or older
  • Life expectancy more than 3 months
  • Confirmed CD20 positive Marginal Zone Lymphoma (a type of blood cancer) that requires treatment
  • At least one measurable tumor of size 1.5 cm or larger that can be seen on CT scan or MRI
  • Normal kidney function with serum creatinine level of 2mg/dl or less
  • Negative HIV test
  • For women who can become pregnant:
    • Negative pregnancy test
    • Agreement to use effective birth control during treatment and for 18 months after
    • For men: Agreement not to father a child during treatment and for 6 months after
    • Blood test results showing:
      • Platelet count of at least 50,000 per microliter
      • Neutrophil count (type of white blood cells) of at least 750 per microliter
      • Liver function tests within acceptable ranges
      • Ability to attend all scheduled appointments and follow study procedures
      • Signed informed consent form showing understanding of the study

Who cannot join the trial?

14 criteria

  • Age below 18 years old
  • Previous systemic treatment for Marginal Zone Lymphoma (a type of blood cancer)
  • Previous treatment with Obinutuzumab (a cancer-fighting drug)
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • Serious heart conditions or uncontrolled heart disease
  • Severe kidney or liver dysfunction
  • Other active cancers requiring treatment
  • Pregnancy or breastfeeding
  • Mental conditions that prevent understanding of the study requirements
  • Known allergies to the study medication or its components
  • Participation in other clinical trials within the last 30 days
  • Major surgery within 28 days before starting the treatment
  • Uncontrolled medical conditions that could interfere with the study
  • History of other cancers within the past 5 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
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Investigated drugs

Obinutuzumab is a targeted therapy medication used in cancer treatment. It belongs to a class of drugs called monoclonal antibodies. This medication works by attaching to a specific protein (CD20) found on certain types of blood cells, including lymphoma cells. It helps your immune system identify and destroy these cancer cells. Obinutuzumab is used to treat various types of blood cancers, and in this trial, it's being studied as a single-agent treatment for marginal zone lymphoma (MZL).

What is already known about the treatment

Obinutuzumab - A monoclonal antibody medication administered through intravenous infusion, specifically designed to target CD20-positive B cells in blood cancers. This drug belongs to the class of targeted immunotherapy agents and is currently used in the treatment of various lymphomas, including Marginal Zone Lymphoma (MZL). Obinutuzumab works by binding to the CD20 protein on B lymphocytes, triggering the body's immune system to destroy these cells while also directly causing cell death, making it particularly effective in treating B-cell lymphomas. The medication has shown promising results in clinical trials as a first-line treatment option for patients who are not eligible for local therapy or have failed previous treatments.

Investigated diseases

Marginal Zone Lymphoma - A type of slow-growing B-cell lymphoma that develops in the marginal zone of lymphoid tissue. It typically begins in B-lymphocytes (a type of white blood cell) and can occur in several specific areas of the body, including the spleen, lymph nodes, and mucosa-associated lymphoid tissues (MALT). The condition can develop in three distinct forms: nodal, extranodal (MALT lymphoma), and splenic marginal zone lymphoma. The disease often progresses slowly, and some patients may not experience symptoms for long periods. Common signs include enlarged lymph nodes, tiredness, and in some cases, unexplained weight loss.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517476-38-00Protocol codeOYLMP-1Estimated enrolment56 patientsSponsorUniversitaetsklinikum Ulm AöR

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