Ongoing Clinical Trials for Nodal Marginal Zone B-cell Lymphoma
There are currently 4 clinical trials investigating new treatments for nodal marginal zone B-cell lymphoma. These studies are testing various targeted therapies and immunotherapies, including bispecific antibodies, CAR T-cell therapy, and combinations of established medications. Trials are taking place across several European countries, offering patients access to innovative treatment approaches.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Espagne
- France
- Germany
- Study Comparing Odronextamab and Lenalidomide with Rituximab and Lenalidomide for Patients with Relapsed/Refractory Follicular and Marginal Zone Lymphoma
- Study on Lisocabtagene Maraleucel for Adults with Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma
- Study of Obinutuzumab as First-Line Treatment for Adult Patients with Marginal Zone Lymphoma Who Are Not Eligible for Local Therapy
- Study on Copanlisib and Rituximab for Patients with Marginal Zone Lymphoma Needing Treatment After Local Therapy Failure or Relapse
- Italy
- Poland
- Spain
- Sweden
Study Comparing Odronextamab and Lenalidomide with Rituximab and Lenalidomide for Patients with Relapsed/Refractory Follicular and Marginal Zone Lymphoma
This trial is comparing two different treatment combinations for patients whose disease has returned or has not responded to previous treatments. The study involves two groups: one receiving odronextamab combined with lenalidomide, and another receiving rituximab combined with lenalidomide.
Who can join: Patients must have confirmed follicular lymphoma or marginal zone lymphoma that has either returned after treatment or has not responded to at least one previous therapy that included chemotherapy combined with immunotherapy. The disease must be measurable on imaging scans such as CT or MRI. Participants need to be well enough to carry out daily activities with little or no assistance, and their blood counts and organ function must be within acceptable ranges.
Who cannot join: Patients with a different type of cancer than those being studied, those who have not experienced a return or worsening of their condition, and those outside the specified age range are not eligible. Additionally, people who are pregnant or breastfeeding, have other serious health conditions, or have received certain recent treatments that might affect the study results cannot participate.
What the trial tests: The study evaluates whether the combination of odronextamab and lenalidomide works better than rituximab and lenalidomide in preventing the cancer from getting worse. Researchers will measure how long participants live without their disease progressing, known as progression-free survival. The trial begins with a safety phase to ensure the odronextamab and lenalidomide combination is well-tolerated before moving to the main comparison phase.
Investigational drugs: Odronextamab is a bispecific antibody that targets specific proteins on cancer cells, helping the immune system recognize and attack them. Lenalidomide is an immunomodulatory drug that helps the immune system fight cancer by affecting how it functions and directly slowing cancer cell growth. Rituximab is a monoclonal antibody that targets a protein called CD20 on the surface of certain cancer cells, helping the immune system destroy them.
Study on Lisocabtagene Maraleucel for Adults with Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma
This trial tests a gene therapy treatment called lisocabtagene maraleucel for patients whose lymphoma has returned or has not responded to previous treatments. The therapy involves modifying a patient’s own immune cells outside the body to better recognize and attack cancer cells when returned to the patient.
Who can join: Patients must be at least 18 years old with confirmed follicular lymphoma or marginal zone lymphoma that has relapsed or is refractory. They need to have good vascular access for a procedure called leukapheresis, which collects white blood cells. The disease must be measurable on imaging tests, and patients must have received specific previous treatments including certain types of drugs and therapies. Women of childbearing age must have negative pregnancy tests and agree to effective birth control for 12 months after treatment. Men must also agree to use contraception during this time.
Who cannot join: Patients with a different type of cancer, those with unresolved recent infections, pregnant or breastfeeding women, and people with severe allergic reactions to similar treatments cannot participate. Those with serious medical conditions that could interfere with the study, inability to follow study procedures, recent major surgeries, or participation in other clinical trials are also excluded.
What the trial tests: The study evaluates the effectiveness and safety of lisocabtagene maraleucel, a form of CAR T-cell therapy. Researchers will assess how well the treatment works in preventing cancer progression, overall survival, and quality of life changes. The trial involves collecting white blood cells through leukapheresis, administering chemotherapy to prepare the body, then giving the modified cells through an intravenous infusion, followed by regular monitoring and long-term follow-up.
Investigational drug: Lisocabtagene maraleucel is a CAR T-cell therapy that involves modifying a patient’s own immune cells to better recognize and attack lymphoma cells. This personalized treatment aims to improve the immune system’s effectiveness in targeting and destroying cancer cells.
Study of Obinutuzumab as First-Line Treatment for Adult Patients with Marginal Zone Lymphoma Who Are Not Eligible for Local Therapy
This trial tests obinutuzumab as a first treatment option for patients with marginal zone lymphoma who cannot receive or have not responded to local treatments such as surgery or radiotherapy. The medication is given as a single treatment without being combined with other cancer drugs.
Who can join: Patients must be 18 years or older with confirmed CD20 positive marginal zone lymphoma requiring treatment. They need at least one measurable tumor of 1.5 cm or larger visible on CT or MRI scans. Normal kidney function, negative HIV test, acceptable blood counts including platelets and neutrophils, and liver function tests within acceptable ranges are required. Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control during treatment and for 18 months after. Men must agree not to father a child during treatment and for 6 months after.
Who cannot join: Those under 18 years old, patients who have received previous systemic treatment for marginal zone lymphoma or previous treatment with obinutuzumab cannot participate. People with active infections including hepatitis B, hepatitis C, or HIV, serious heart conditions, severe kidney or liver dysfunction, other active cancers, pregnancy or breastfeeding, mental conditions preventing understanding of study requirements, known allergies to the study medication, participation in other trials within 30 days, major recent surgery, or uncontrolled medical conditions are excluded.
What the trial tests: The study evaluates how well obinutuzumab works as a first-line single-agent treatment and what side effects it may cause. Researchers will monitor participants’ response to treatment, track side effects, and assess quality of life throughout the treatment period, which may last up to 30 months.
Investigational drug: Obinutuzumab is a monoclonal antibody that attaches to a specific protein called CD20 found on certain blood cells, including lymphoma cells. It helps the immune system identify and destroy these cancer cells while also directly causing cell death.
Study on Copanlisib and Rituximab for Patients with Marginal Zone Lymphoma Needing Treatment After Local Therapy Failure or Relapse
This trial tests the combination of copanlisib and rituximab for patients who need treatment for marginal zone lymphoma, especially those who have not responded to or are not eligible for local treatments like surgery or radiotherapy.
Who can join: Patients must be at least 18 years old with confirmed CD20 positive marginal zone lymphoma requiring treatment. They need a life expectancy of more than 3 months and specific blood counts including platelets of at least 50 G/L and neutrophils of at least 0.75 G/L. Liver enzymes must be no more than 3 times normal values, and kidney function must show a glomerular filtration rate of at least 40 mL/min. Negative HIV test is required. For certain viral infections, specific testing criteria apply. Women of childbearing potential must have negative pregnancy tests and use effective birth control, and men must agree not to father a child during and for 6 months after the study. Patients need at least one measurable lesion of 1.5 cm by CT or MRI.
Who cannot join: Patients with a different type of cancer other than marginal zone lymphoma, those not needing treatment, patients who have not failed or are eligible for local therapy, those whose cancer has not relapsed, patients outside the specified age range, and those considered part of a vulnerable population cannot participate.
What the trial tests: The study evaluates the effectiveness and safety of combining copanlisib and rituximab. Researchers will check for complete remission, monitor side effects, and assess quality of life. The treatment lasts about 12 months and includes an induction phase with both medications followed by maintenance therapy with rituximab. Regular imaging studies and laboratory tests track treatment progress and response duration.
Investigational drugs: Copanlisib is a PI3K inhibitor that blocks certain proteins cancer cells need to grow and survive. It is given intravenously and is classified as a targeted cancer therapy. Rituximab is a monoclonal antibody that targets the CD20 protein on B-cells, leading to their destruction. It is also administered intravenously and is a well-established immunotherapy medication used in combination with other drugs.
Summary
The four ongoing clinical trials for nodal marginal zone B-cell lymphoma reflect a diverse range of treatment approaches for this condition. Three trials focus on patients whose disease has relapsed or not responded to previous treatments, while one trial tests a first-line treatment option.
Germany stands out as having the most trial opportunities with all four studies available, making it a particularly accessible location for patients seeking enrollment. Several other European countries including France, Spain, Austria, Italy, and Sweden also offer multiple trial options.
The trials test various innovative therapies including bispecific antibodies, CAR T-cell therapy, and targeted inhibitors, often combined with established immunotherapy medications. Three of the four studies involve combinations of treatments, while one tests a single-agent therapy. Most trials require patients to have measurable disease on imaging scans and acceptable blood counts and organ function.
These studies represent important advances in treatment options for patients with nodal marginal zone B-cell lymphoma, particularly for those whose disease has proven difficult to treat with conventional approaches.
