Ongoing Clinical Trials for Diffuse Large B-Cell Lymphoma Stage I
This article provides information about 2 ongoing clinical trials for patients with diffuse large B-cell lymphoma stage I. These studies are testing new treatment approaches including targeted medications and DNA-guided therapy strategies. Trials are currently recruiting in Belgium, Netherlands, and Poland.
Clinical trial locations
- Belgium
- Netherlands
- Poland
Study on Golcadomide for Patients with Relapsed or Refractory Large B-Cell Lymphoma in the Brain
This clinical trial is evaluating Golcadomide, an investigational medication for patients with large B-cell lymphoma that has spread to the brain or central nervous system. The study focuses on cases where the cancer has either returned after previous treatment or has not responded to standard therapies.
Main inclusion criteria: To participate, you must be at least 18 years old with a confirmed diagnosis of secondary central nervous system lymphoma or relapsed or refractory primary large B-cell lymphoma affecting the central nervous system. Patients in Cohort A must have previously received high-dose methotrexate-based chemotherapy. Cohort B patients should have aggressive malignant B-cell lymphoma including follicular lymphoma grade 3B, diffuse large B-cell lymphoma, or high-grade B-cell lymphoma with specific genetic changes. You need to have a WHO performance status of 2 or less, meaning you can still perform most daily activities. Adequate blood cell counts are required, including hemoglobin greater than 5 mmol/l, neutrophils greater than 1.0×10⁹/l, and platelets greater than 75×10⁹/l.
Main exclusion criteria: The trial excludes certain specific conditions. However, the primary focus is on recruiting patients with relapsed or refractory disease, secondary CNS involvement, or primary CNS lymphoma who meet the inclusion requirements.
Trial focus: The study aims to determine how effective Golcadomide is in achieving complete or partial remission in patients with brain lymphoma. Researchers will monitor how long responses last, overall survival rates, and the medication’s safety profile. The trial will also examine how the drug behaves in the body, particularly comparing its levels in spinal fluid versus blood, and investigate genetic factors that might influence treatment response.
Investigational drug: Golcadomide (CC-99282) is taken orally as a capsule. It works by interfering with specific pathways that cancer cells use to grow and survive, thereby stopping their multiplication. This is a phase 2 study designed to gather information about the medication’s effectiveness and safety. The trial is expected to run until 2028, with recruitment beginning in 2025.
Study on the Effectiveness and Safety of Cytarabine, Tafasitamab, and Lenalidomide for Patients with Relapsed Diffuse Large B-Cell Lymphoma
This trial is investigating an innovative approach to treating patients with aggressive B-cell lymphomas, including diffuse large B-cell lymphoma and high-grade B-cell lymphoma. The study uses blood tests to detect tumor DNA, which helps doctors decide when to start second-line treatment early, potentially before symptoms appear.
Main inclusion criteria: You must be at least 18 years old with a confirmed diagnosis of diffuse large B-cell lymphoma or high-grade B-cell lymphoma. You should be eligible for standard chemotherapy treatments such as R-CHOP or similar regimens. Important requirements include having test results available from before your first treatment, including mutation analysis and circulating tumor DNA assessments. You must have PET-CT scans performed before and after your initial treatment. Your ECOG performance status should be 0-2, or 3 if related to disease progression, meaning you are able to care for yourself with some limitations. Women of childbearing age need a negative pregnancy test and must agree to use effective contraception during and after the trial. Patients must be in complete remission confirmed by PET-CT scan after completing first-line treatment.
Main exclusion criteria: The trial excludes patients with other types of cancer unrelated to the lymphomas being studied. You cannot participate if you have not fully recovered from previous cancer treatments or their side effects. Patients with severe heart problems, uncontrolled high blood pressure, or active infections requiring treatment are not eligible. Pregnant or breastfeeding women cannot join the study. Those with a history of severe allergic reactions to similar treatments or other serious medical conditions that could interfere with the study are excluded. You must be able to follow study procedures and attend all required visits.
Trial focus: The study evaluates whether starting second-line treatment early, guided by blood tests that detect circulating tumor DNA, can improve outcomes for patients with relapsed disease. Researchers will assess the overall response rate to treatment and monitor for significant side effects. The trial also includes quality of life assessments using standardized questionnaires to understand how treatment affects patients’ daily wellbeing.
Investigational approach and drugs: The trial uses a combination of several medications including Cytarabine, Tafasitamab, Lenalidomide, Dexamethasone, Cisplatin, Bendamustine Hydrochloride, Polatuzumab Vedotin, and Rituximab. These are administered through various routes including oral tablets and intravenous infusions. The key innovation is using cell-free circulating tumor DNA levels in blood to guide when to start treatment, allowing doctors to detect cancer recurrence early and begin therapy sooner. This personalized approach aims to improve patient outcomes by catching disease progression at an earlier stage. The study is expected to continue until early 2026.
Summary
Currently, two clinical trials are actively recruiting patients with diffuse large B-cell lymphoma stage I across three European countries. These trials represent different therapeutic approaches: one focuses on a novel targeted oral medication for patients with central nervous system involvement, while the other investigates an innovative DNA-guided strategy for timing second-line treatment.
Geographically, the trials show a concentration in Western and Central Europe, with Belgium and the Netherlands hosting one study together, and Poland conducting the other independently. Both trials address the challenging situation of relapsed or refractory disease, recognizing that some patients do not achieve lasting remission with initial treatments.
The diversity in approaches is notable. The Golcadomide study specifically targets patients whose lymphoma has affected the brain or spinal cord, an area that can be difficult to treat. The second trial represents a shift toward precision medicine, using blood-based biomarkers to personalize treatment timing rather than waiting for clinical symptoms to appear.
Patients interested in participating should discuss eligibility criteria carefully with their healthcare providers, as both trials have specific requirements regarding previous treatments, overall health status, and disease characteristics. The trials are expected to provide valuable information about new treatment strategies for this aggressive form of lymphoma.
