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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Institut Fuer Versorgungsforschung In Der Onkologie GbR Koblenz Germany
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie Munster Germany
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Uteifborpjixengmtzylb Eduid Adv Essen Germany
Algbaggauslwssetxqfpasz guphz Bochum Germany
Kcgjrvdqkjfynkf Passau Germany
Uczcnxpdoxryepjeysenx Mxfrzmud Asp Munster Germany
Mxcymoaflacsnqkjthwwdwofxc Habqpwgbvvqgvccd Halle (Saale) Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
15.01.2019

Trial locations

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).

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 ID:
2024-517476-38-00
Protocol code:
OYLMP-1
NCT ID:
NCT03322865
Trial Phase:
Therapeutic exploratory (Phase II)

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