Ongoing Clinical Trials for Diffuse Large B-Cell Lymphoma Stage III
There are currently 2 ongoing clinical trials exploring new treatment approaches for patients with diffuse large B-cell lymphoma stage III. These studies are investigating innovative medications and treatment strategies, including early intervention based on tumor DNA detection and new drugs targeting brain involvement. Trials are being conducted 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 trial is evaluating Golcadomide, an oral medication taken as a capsule, for patients whose large B-cell lymphoma has spread to the brain or central nervous system. The study focuses on cases where the disease has either returned after previous treatment or has not responded to earlier therapies.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of 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. Patients in Cohort A must have received prior high-dose methotrexate-based chemotherapy. Those in Cohort B need a tissue-confirmed diagnosis of aggressive malignant B-cell lymphoma with central nervous system involvement. Adequate blood counts are required, including hemoglobin greater than 5 mmol/l, neutrophil count greater than 1.0×109/l, and platelet count greater than 75×109/l. Patients must have a WHO performance status of 2 or less, meaning they can still perform most daily activities.
Main exclusion criteria: The trial excludes patients with certain forms of secondary, relapsed, or refractory primary large B-cell lymphoma of the central nervous system that do not meet the specific criteria outlined in the inclusion requirements.
Focus and goal: The primary goal is to determine how well Golcadomide works in treating these aggressive forms of lymphoma affecting the brain and central nervous system. Researchers will monitor whether patients achieve complete or partial remission, the time it takes for the best response to occur, the duration of that response, and overall survival. The study will also evaluate side effects, quality of life, and how the medication behaves in the body, including its presence in spinal fluid compared to blood. Some participants may receive a placebo for comparison purposes.
Investigational drug: Golcadomide (CC-99282) is being tested to see if it can help reduce cancer size or achieve complete remission in patients with lymphoma affecting the central nervous system. It works by interfering with specific pathways that cancer cells use to grow and survive, thereby stopping their proliferation.
Study on the Effectiveness and Safety of Cytarabine, Tafasitamab, and Lenalidomide for Patients with Relapsed Diffuse Large B-Cell Lymphoma
This clinical trial explores a novel approach for patients with relapsed diffuse large B-cell lymphoma or high-grade B-cell lymphoma. The study uses tumor DNA levels detected in blood samples to guide when to start a second-line treatment early, potentially improving outcomes by catching cancer recurrence sooner.
Main inclusion criteria: Patients must be at least 18 years old with a confirmed diagnosis of diffuse large B-cell lymphoma or high-grade B-cell lymphoma. They should be eligible for standard chemotherapy treatments such as R-CHOP, R-CHOP-like, Pola-R-CHP, or DA-EPOCH-R. Participants must have completed first-line treatment and achieved complete remission confirmed by a PET-CT scan. Test results must be available, including mutation analysis in blood before starting first-line treatment and assessment of circulating tumor DNA during and after treatment. Patients need an ECOG performance status of 0-2, or 3 if related to disease progression, meaning they can perform most or some daily activities. Women of childbearing age must have a negative pregnancy test and agree to use effective contraception.
Main exclusion criteria: Patients with other types of cancer unrelated to these specific lymphomas cannot participate. Those who have not completed previous treatments or recovered from their side effects are excluded. Patients with severe heart problems, uncontrolled high blood pressure, or active infections requiring treatment are not eligible. Pregnant or breastfeeding women, those with a history of allergic reactions to similar treatments, or those with other serious medical conditions that could interfere with the study are also excluded.
Focus and goal: The main objective is to evaluate the effectiveness and safety of starting second-line treatment early based on circulating tumor DNA levels in the blood. This approach aims to detect cancer recurrence sooner and begin treatment before symptoms appear or worsen. The study monitors overall response rates, side effects, and quality of life using the EORTC QLQ-C30 questionnaire. Regular assessments include blood tests to measure tumor DNA and imaging studies to track disease progression.
Investigational drugs: The trial uses multiple medications including Cytarabine, Tafasitamab (MOR00208), Lenalidomide, Dexamethasone, Cisplatin, Bendamustine Hydrochloride, Polatuzumab Vedotin (RO5541077), and Rituximab. These are administered through various routes including oral tablets and intravenous infusions. The specific treatment plan is guided by the detection of tumor DNA in blood samples, allowing doctors to tailor therapy to each patient’s needs.
Summary
The two ongoing trials for diffuse large B-cell lymphoma stage III represent different innovative approaches to treatment. The first study focuses specifically on cases involving the brain and central nervous system, testing a new oral medication called Golcadomide in Belgium and the Netherlands. The second trial, conducted in Poland, explores an early intervention strategy using tumor DNA monitoring in blood to guide when to start second-line treatment with multiple medications.
Both studies target relapsed or difficult-to-treat cases, addressing situations where standard therapies may have failed or where the disease has returned. The trials demonstrate a geographic concentration in European countries and reflect current research trends toward personalized treatment approaches, whether through novel targeted medications or DNA-guided therapy timing. These studies aim to improve outcomes for patients facing aggressive forms of this disease, though they are still in the investigational phase and effectiveness has not yet been established.
