Ongoing Clinical Trials for Diffuse Large B-Cell Lymphoma Stage II
Currently, there are 2 ongoing clinical trials investigating new treatment approaches for patients with diffuse large B-cell lymphoma stage II. These studies are being conducted in Belgium, the Netherlands, and Poland, testing investigational medications and treatment strategies for patients who have experienced relapse or have cancer that has not responded to previous treatments.
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 investigating the effectiveness of a medication called Golcadomide for treating large B-cell lymphoma that affects the brain. The study focuses on patients whose lymphoma has either returned after previous treatment or has not responded to earlier therapies.
Main inclusion criteria: To participate in this study, you must be at least 18 years old and have a specific diagnosis that includes either secondary central nervous system lymphoma, relapsed primary large B-cell lymphoma of the central nervous system, or refractory primary large B-cell lymphoma of the central nervous system. You must have received prior high-dose methotrexate-based chemotherapy if you qualify for Cohort A. For Cohort B, you need to have an aggressive malignant B-cell lymphoma confirmed by tissue sample, including follicular lymphoma grade 3B, diffuse large B-cell lymphoma, or high-grade B-cell lymphoma with specific genetic rearrangements. Your cancer must have progressed or relapsed with involvement of the central nervous system, and this involvement must be confirmed through cerebrospinal fluid analysis, MRI evidence, or biopsy. You must have adequate blood counts, including hemoglobin greater than 5 mmol/l, neutrophil count greater than 1.0×109/l, and platelet count greater than 75×109/l. Your WHO performance status must be 2 or less, meaning you can perform most daily activities.
Main exclusion criteria: The study excludes patients with secondary central nervous system lymphoma, relapsed primary large B-cell lymphoma of the central nervous system, and refractory primary large B-cell lymphoma of the central nervous system in certain cohorts.
Trial focus: The main goal of this study is to evaluate whether Golcadomide can help reduce the size of the cancer or make it disappear completely. Participants will take the medication as a capsule by mouth, and researchers will monitor various outcomes including the time it takes for the best response to occur, how long the response lasts, overall survival, side effects, and quality of life. The study will also examine how the medication behaves in the body and explore genetic factors that might influence treatment response.
Investigational drug: Golcadomide (CC-99282) is the medication being tested in this phase 2 study. It works by interfering with specific pathways that cancer cells use to grow and survive, thereby stopping their growth. This investigational drug is taken orally and is specifically being studied for its potential to treat brain lymphomas.
Study on the Effectiveness and Safety of Cytarabine, Tafasitamab, and Lenalidomide for Patients with Relapsed Diffuse Large B-Cell Lymphoma
This clinical trial is examining an early treatment approach for patients with diffuse large B-cell lymphoma or high-grade B-cell lymphoma who have experienced a relapse. The study uses levels of tumor DNA in the blood to guide when to start a second round of treatment.
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 like R-CHOP, R-CHOP-like, Pola-R-CHP, or DA-EPOCH-R. Before joining, you must have specific test results available, including mutation analysis in blood before starting first-line treatment, assessment of circulating free DNA from the tumor during and after treatment, and PET-CT scans before and after first-line treatment. Your ECOG performance status should be 0-2, or 3 if caused by disease progression, which measures your ability to carry out daily activities. You must be in complete remission confirmed by a PET-CT scan after completing first-line treatment. Women of childbearing age must have a negative pregnancy test and agree to use effective contraception during and after the trial.
Main exclusion criteria: The study excludes patients with other types of cancer unrelated to these specific lymphomas, those who have not completed previous treatments or recovered from side effects, patients with severe heart problems or uncontrolled high blood pressure, those with active infections requiring treatment, pregnant or breastfeeding women, patients with a history of allergic reactions to similar treatments, those with serious medical conditions that could interfere with the study, and patients unable to follow study procedures or attend required visits.
Trial focus: The study aims to evaluate the effectiveness and safety of starting a second-line treatment early based on the detection of tumor DNA in the blood. By monitoring these DNA levels, doctors can determine if the cancer is returning and begin treatment sooner, potentially improving outcomes. The trial will assess the overall response rate to the second-line treatment, monitor any significant side effects, and evaluate participants’ quality of life using a specific questionnaire.
Investigational approach: This study uses cell-free circulating tumor DNA found in the blood as a guide for treatment decisions. The treatment involves several medications including Cytarabine, Tafasitamab (MOR00208), Lenalidomide, Dexamethasone, Cisplatin, Bendamustine Hydrochloride, Polatuzumab Vedotin (RO5541077), and Rituximab. These medications are administered through various methods including oral tablets and intravenous infusions, with dosages and frequency determined by your healthcare team.
Summary
The two ongoing clinical trials for diffuse large B-cell lymphoma stage II represent different treatment strategies for patients who have experienced relapse or have cancer that has not responded to previous treatments. The first trial, conducted in Belgium and the Netherlands, focuses specifically on lymphoma affecting the brain and tests a single investigational drug called Golcadomide. The second trial, taking place in Poland, uses a more complex approach involving multiple medications and is guided by tumor DNA levels in the blood to determine the optimal timing for starting second-line treatment.
Both studies require participants to be adults with specific diagnoses and adequate overall health status. The trials are expected to continue through 2026 and 2028 respectively, with the goal of improving treatment outcomes and quality of life for patients with these aggressive forms of lymphoma. Patients interested in participating should discuss eligibility requirements with their healthcare providers, as both studies have specific inclusion and exclusion criteria that must be met.
