Ongoing Clinical Trials for Extranodal Marginal Zone B-Cell Lymphoma (MALT Type)
There are currently 3 ongoing clinical trials for patients with Extranodal Marginal Zone B-Cell Lymphoma (MALT type). These trials are testing different treatment approaches, including obinutuzumab as a single agent, a combination of chlorambucil and rituximab, and a combination of copanlisib and rituximab. The trials are being conducted in Germany, Italy, and France, offering opportunities for patients who need treatment after local therapy has failed or who are not eligible for local treatments.
Clinical trial locations
- France
- Germany
- Italy
Study of Obinutuzumab as First-Line Treatment for Adult Patients with Marginal Zone Lymphoma Who Are Not Eligible for Local Therapy
This trial is testing obinutuzumab (also known as Gazyvaro) as a first treatment option for patients with Marginal Zone Lymphoma who cannot receive local treatments such as surgery or radiation, or for whom these treatments have not worked. Obinutuzumab is a monoclonal antibody that targets a specific protein called CD20 found on the surface of certain blood cells, including lymphoma cells. By attaching to this protein, the medication helps the immune system recognize and destroy cancer cells.
Main inclusion criteria: Participants must be at least 18 years old with a life expectancy of more than 3 months. They need to have confirmed CD20-positive Marginal Zone Lymphoma that requires treatment, with at least one measurable tumor of 1.5 cm or larger visible on CT scan or MRI. Normal kidney function is required, along with negative HIV test results. Women of childbearing age must have a negative pregnancy test and agree to use effective birth control during treatment and for 18 months afterward. Men must agree not to father a child during treatment and for 6 months after. Blood test results must show adequate platelet and neutrophil counts, and liver function tests must be within acceptable ranges.
Main exclusion criteria: Patients under 18 years old cannot participate. Those who have received previous systemic treatment for the condition or previous treatment with obinutuzumab are excluded. Patients with active or chronic infections including hepatitis B, hepatitis C, or HIV cannot join. Those with serious heart conditions, severe kidney or liver dysfunction, other active cancers requiring treatment, pregnancy, or breastfeeding are also excluded. Additionally, patients with known allergies to the study medication, those who participated in other clinical trials within the last 30 days, or those who had major surgery within 28 days before starting treatment cannot participate.
Focus of the trial: The study aims to evaluate how well obinutuzumab works as a single treatment and what side effects it may cause. The medication is given through an intravenous infusion at a dose of 1,000 mg during an initial treatment phase. Four weeks after completing this phase, doctors will evaluate the response to treatment using medical imaging tests. Regular check-ups will continue throughout the study period, which may last up to 30 months, with ongoing monitoring extending until 2029. The study will also assess quality of life using a questionnaire called FACTLym.
Study on Chlorambucil and Rituximab for Patients with MALT Lymphoma
This trial is investigating the combination of two medications: chlorambucil and rituximab. Chlorambucil is an oral medication that slows or stops the growth of cancer cells, while rituximab is a monoclonal antibody that targets and destroys specific cancer cells. The study involves an initial 6-month treatment phase using both medications together, followed by a 2-year maintenance phase using rituximab alone.
Main inclusion criteria: Participants must be 18 years or older with a confirmed diagnosis of CD20-positive Extranodal Marginal Zone Lymphoma of the MALT type. The lymphoma can be either newly diagnosed or have returned after previous local treatments like surgery, radiation, or antibiotics for stomach infection. The disease must be measurable or evaluable by doctors and can be at any stage from I to IV according to the Ann Arbor staging system. Both men and women are eligible to participate.
Main exclusion criteria: Patients with a different type of lymphoma other than Extranodal Marginal Zone Lymphoma cannot participate. Those who are not within the specified age range, unable to follow study procedures, or who have other serious health conditions that might interfere with the study are excluded. Pregnant or breastfeeding women cannot join. Patients with allergies to chlorambucil or rituximab, those who participated in another clinical trial recently, or those with a history of certain infections or diseases that could affect study results are also excluded.
Focus of the trial: The study aims to evaluate the safety and effectiveness of combining chlorambucil and rituximab. During the 6-month induction phase, participants receive both medications, with chlorambucil given orally and rituximab administered as a subcutaneous injection under the skin. The maintenance phase continues for 2 years with rituximab alone. Throughout the study, regular evaluations monitor treatment response and side effects. The primary goal is to assess the complete remission rate at the end of the induction phase. Secondary evaluations include progression-free survival, event-free survival at 5 years, overall survival, response duration, and both short-term and long-term side effects.
Study on Copanlisib and Rituximab for Patients with Marginal Zone Lymphoma Needing Treatment After Local Therapy Failure or Relapse
This trial is testing the combination of copanlisib and rituximab for patients who need treatment after local therapy has failed or whose condition has returned. Copanlisib is a PI3K inhibitor that blocks certain proteins cancer cells need to grow, while rituximab is a monoclonal antibody that helps the immune system attack and destroy cancer cells. Both medications are given through intravenous infusion directly into a vein.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of CD20-positive Marginal Zone Lymphoma and a life expectancy of more than 3 months. They need to be in need of treatment for symptomatic disease that is new or has returned after local therapy. Baseline platelet count must be at least 50 G/L and absolute neutrophil count at least 0.75 G/L. Liver enzyme levels must be no more than 3 times the normal value, and total bilirubin must be no more than 2 mg/dL or 2 times normal. Kidney function must show a glomerular filtration rate of at least 40 mL/min/1.73 m². HIV test must be negative. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study. Men must agree not to father a child during and for 6 months after the study. For nodal and extranodal forms, at least one measurable lesion of at least 1.5 cm must be present on CT or MRI. For splenic form, an enlarged spleen and lymphoma cell presence in bone marrow or blood with specific symptoms is required.
Main exclusion criteria: Patients with a different type of cancer other than Marginal Zone Lymphoma cannot participate. Those who are not in need of treatment, have not failed local therapy, are eligible for local therapy, or have not relapsed are excluded. Patients not within the specified age range or not part of the specified clinical trial group cannot join. Those considered part of a vulnerable population requiring special protection or care are also excluded.
Focus of the trial: The study aims to test the effectiveness and safety of combining copanlisib and rituximab. After eligibility is confirmed and informed consent is obtained, participants enter an induction therapy phase receiving both medications intravenously at dosages determined by healthcare providers. This is followed by a maintenance therapy phase continuing with rituximab. Regular assessments are conducted throughout the approximately 12-month study period to evaluate treatment response using imaging studies and laboratory tests. Quality of life is assessed periodically using a questionnaire designed for lymphoma patients. The study will document time to best response, duration of response, overall survival, and any side effects.
Summary
Currently, three clinical trials are actively recruiting patients with Extranodal Marginal Zone B-Cell Lymphoma (MALT type). The trials are geographically concentrated in European countries, with Germany hosting two trials and France and Italy each hosting one trial. All three studies focus on different treatment approaches, offering patients various options depending on their specific situation.
The trials investigate both single-agent and combination therapies. Two of the studies explore combination treatments: one combining chlorambucil and rituximab, and another combining copanlisib and rituximab. The third trial tests obinutuzumab as a single agent. Notably, rituximab appears in two of the three trials, highlighting its continued importance in treatment approaches for this condition.
The studies target different patient populations. One trial specifically focuses on first-line treatment for patients not eligible for local therapy, while the other two address patients who have failed local therapy or experienced relapse. Treatment durations vary considerably, ranging from approximately 12 months to as long as 30 months, with some studies including extended maintenance phases lasting up to 2 years.
All trials share common goals of evaluating treatment effectiveness, monitoring side effects, and assessing quality of life for participants. They require participants to be at least 18 years old and to have confirmed CD20-positive disease, reflecting standard diagnostic criteria for this condition.
