Clinical Trials for Splenic Marginal Zone Lymphoma
There are currently 4 ongoing clinical trials investigating new treatments for splenic marginal zone lymphoma. These studies are testing various medication combinations across multiple European countries, including treatments with bispecific antibodies, BTK inhibitors, and monoclonal antibodies. The trials aim to improve outcomes for both newly diagnosed patients and those whose disease has returned or not responded to previous treatments.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- Espagne
- France
- Germany
- Study Comparing Odronextamab and Lenalidomide with Rituximab and Lenalidomide for Patients with Relapsed/Refractory Follicular and Marginal Zone 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
- Norway
- 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 testing two different treatment combinations for patients whose lymphoma has returned or has not responded to previous therapy. The study compares a newer treatment approach using odronextamab combined with lenalidomide against the more established combination of rituximab and lenalidomide.
Inclusion criteria: Patients must have confirmed follicular lymphoma or marginal zone lymphoma that has either not responded to treatment or has returned after at least one previous therapy that included chemotherapy, immunotherapy, and an anti-CD20 antibody. The disease must be measurable using CT or MRI scans. Participants need to have adequate blood counts and organ function, and be able to perform daily activities reasonably well, as measured by an ECOG performance status of 0 to 2.
Exclusion criteria: Patients cannot participate if they have a different type of cancer, have not experienced disease progression after treatment, fall outside the specified age range, belong to a vulnerable population requiring special protection, have serious health conditions that would interfere with the study, are pregnant or breastfeeding, have had recent treatments that might affect results, or cannot follow study procedures.
Focus of the trial: The study begins with a safety phase to evaluate how well patients tolerate the combination of odronextamab and lenalidomide. Following this, participants are randomly assigned to receive either odronextamab plus lenalidomide or rituximab plus lenalidomide. The main goal is to measure progression-free survival, which means how long patients live without their disease getting worse. Regular monitoring includes blood tests, imaging studies, and quality of life assessments.
Investigational drugs: Odronextamab is a bispecific antibody that targets both CD20 and CD3 proteins, helping the immune system recognize and attack cancer cells. Lenalidomide is an immunomodulatory drug that enhances the immune response against cancer cells. Rituximab is a monoclonal antibody that targets the CD20 protein on cancer cells, triggering their destruction by the immune system.
Study Comparing Rituximab and Zanubrutinib with Rituximab Alone for Untreated Patients with Splenic Marginal Zone Lymphoma
This trial specifically focuses on patients who have not yet received any treatment for their splenic marginal zone lymphoma. The study investigates whether adding zanubrutinib to rituximab provides better results than using rituximab alone.
Inclusion criteria: Patients must be 18 years or older with confirmed splenic marginal zone lymphoma that requires treatment according to medical guidelines. They need to have measurable disease, adequate blood counts including sufficient white blood cells and platelets, and proper liver and kidney function. Women of childbearing potential must have a negative pregnancy test, and all participants must agree to use effective birth control during treatment and for a specific period afterward. Patients must be able to swallow the trial medications and have a performance status of 0, 1, or 2 on the ECOG scale.
Exclusion criteria: The trial excludes patients who have previously received treatment for splenic marginal zone lymphoma or who have had their spleen removed. Those with other serious health conditions that might interfere with the study, pregnant or breastfeeding women, individuals unable to commit to the study schedule, those with a history of severe allergies to similar medications, and patients participating in other clinical trials simultaneously cannot join.
Focus of the trial: After an initial assessment to confirm eligibility, participants are randomly assigned to receive either rituximab alone or rituximab combined with zanubrutinib. Rituximab is given through intravenous infusion, while zanubrutinib is taken orally as capsules. The study evaluates progression-free survival as the primary goal, along with complete remission rates at 12 and 24 months. Regular follow-up visits include physical examinations, blood tests, and imaging studies. The trial is expected to continue until April 2029.
Investigational drugs: Rituximab targets a specific protein on cancer cells, helping the immune system destroy them. Zanubrutinib is a BTK inhibitor that blocks proteins cancer cells need to grow, thereby slowing or stopping their proliferation. The combination aims to provide a more effective treatment approach than rituximab alone.
Study of Obinutuzumab as First-Line Treatment for Adult Patients with Marginal Zone Lymphoma Who Are Not Eligible for Local Therapy
This trial evaluates obinutuzumab as a single-agent first-line treatment for patients with marginal zone lymphoma who cannot receive or have not responded to local treatments such as surgery or radiotherapy.
Inclusion criteria: Patients must be 18 years or older with a confirmed CD20-positive marginal zone lymphoma diagnosis requiring treatment. They need at least one measurable tumor of 1.5 cm or larger visible on CT or MRI scans. Adequate kidney function with serum creatinine of 2 mg/dL or less, a negative HIV test, and acceptable blood counts including at least 50,000 platelets per microliter and 750 neutrophils per microliter are required. Liver function tests must be within acceptable ranges. Women of childbearing potential need a negative pregnancy test and must 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. Patients must be able to attend all scheduled appointments and sign an informed consent form.
Exclusion criteria: The trial excludes patients under 18 years old, those who have received previous systemic treatment for marginal zone lymphoma, anyone previously treated with obinutuzumab, individuals with active or chronic infections including hepatitis B, hepatitis C, or HIV, those with serious heart conditions, severe kidney or liver dysfunction, other active cancers requiring treatment, pregnant or breastfeeding women, individuals with mental conditions preventing understanding of study requirements, those with known allergies to the medication, participants in other recent clinical trials, patients who had major surgery within 28 days before treatment, those with uncontrolled medical conditions, and anyone with a history of other cancers within the past 5 years except successfully treated non-melanoma skin cancer or cervical cancer in situ.
Focus of the trial: The treatment begins with obinutuzumab given through intravenous infusion at a 1,000 mg dose. Four weeks after completing the initial treatment phase, doctors evaluate whether there has been a complete or partial response using medical imaging tests. Regular check-ups continue throughout the study period, with quality of life assessments and monitoring for side effects. Long-term follow-up continues until 2029.
Investigational drug: Obinutuzumab is a monoclonal antibody that targets the CD20 protein found on certain blood cells, including lymphoma cells. It works by attaching to this protein and helping the immune system identify and destroy cancer cells while also directly causing cell death. It is being studied as a single-agent treatment for marginal zone lymphoma.
Study on Copanlisib and Rituximab for Patients with Marginal Zone Lymphoma Needing Treatment After Local Therapy Failure or Relapse
This trial investigates the combination of copanlisib and rituximab for patients whose marginal zone lymphoma has not responded to or has returned after local therapy.
Inclusion criteria: Patients must be at least 18 years old with confirmed CD20-positive marginal zone lymphoma and a life expectancy of more than 3 months. They need adequate blood counts including at least 50 G/L platelets and 0.75 G/L neutrophils, liver enzyme levels no more than 3 times normal values, total bilirubin of no more than 2 mg/dL or 2 times normal, and a glomerular filtration rate of at least 40 mL/min/1.73 m². A negative HIV test is required. 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 the study and for 6 months afterward. Patients must be willing to comply with study visits and procedures, have signed informed consent, and have had tissue diagnostic procedures within 12 months before the study. They must need treatment for symptomatic marginal zone lymphoma that is new or has returned after local therapy, with at least one measurable lesion of 1.5 cm for nodal and extranodal types, or an enlarged spleen with lymphoma cell presence for splenic type.
Exclusion criteria: Patients with a different type of cancer, those not in need of treatment, patients who have not failed or are eligible for local therapy, those whose cancer has not relapsed, individuals outside the specified age range, those not part of the clinical trial group, and vulnerable populations requiring special protection cannot participate.
Focus of the trial: The study includes an induction phase where patients receive both rituximab and copanlisib through intravenous infusion, with dosages tailored to individual needs. This is followed by maintenance therapy with rituximab. Regular assessments evaluate treatment response using imaging studies and laboratory tests, and quality of life is assessed periodically. The study concludes with a final evaluation of treatment response and any long-term effects.
Investigational drugs: Copanlisib is a PI3K inhibitor that blocks certain enzymes helping cancer cells grow and survive. It works by inhibiting proteins that play a role in cancer cell growth. Rituximab is a monoclonal antibody targeting the CD20 protein on B-cells, leading to their destruction. The combination aims to evaluate effectiveness in stopping cancer progression while monitoring for side effects.
Summary
The four ongoing clinical trials for splenic marginal zone lymphoma reflect a diverse approach to treating this rare blood cancer. Two trials focus on patients whose disease has returned or not responded to previous treatment, one specifically targets newly diagnosed patients who have not yet received therapy, and one addresses patients who have failed local treatments.
There is a notable concentration of trials in Germany, which hosts three of the four studies, making it a significant center for this research. Other countries with multiple trials include Austria, France, Italy, and Spain. The trials employ various treatment strategies, including bispecific antibodies like odronextamab, BTK inhibitors such as zanubrutinib, monoclonal antibodies including obinutuzumab and rituximab, and PI3K inhibitors like copanlisib.
These studies aim to determine whether newer medication combinations can improve outcomes compared to established treatments, with most trials measuring progression-free survival as a primary goal. The research represents important efforts to find more effective treatment options for patients with splenic marginal zone lymphoma across different stages of their disease.
