Ongoing Clinical Trials for Diffuse Large B-Cell Lymphoma Stage IV
There are currently 3 clinical trials investigating new treatment approaches for diffuse large B-cell lymphoma stage IV. These studies are testing different medication combinations and treatment strategies for patients whose disease has not yet been treated or has returned after initial therapy. Trials are taking place in Belgium, Germany, Greece, the Netherlands, and Poland.
Clinical trial locations
- Belgium
- Germany
- Greece
- Netherlands
- Poland
Study on Acalabrutinib with Rituximab and Drug Combination for Older Adults with Untreated Diffuse Large B-Cell Lymphoma
This trial is designed for older adults who have not yet received treatment for their condition. The study aims to determine whether adding acalabrutinib to a standard treatment regimen can help patients live longer without their disease worsening.
Main inclusion criteria: Participants must be over 80 years old, or between 60 and 80 years old but not eligible for full-dose chemotherapy. They must have a confirmed diagnosis of CD20-positive lymphoma at stage I with a large tumor (at least 7.5 cm), or stage II, III, or IV. Laboratory tests must show adequate blood counts and organ function unless affected by the lymphoma itself. Patients need to be able to swallow capsules and tablets without difficulty and agree to use effective contraception during the study.
Main exclusion criteria: The study excludes patients who have already received treatment for their condition. Patients younger than 60 years old who are eligible for full-dose chemotherapy cannot participate. Those with severe heart problems, uncontrolled medical conditions, active infections requiring treatment, pregnancy, or breastfeeding are also excluded.
Focus of the trial: The study compares two treatment approaches. One group receives R-miniCHOP chemotherapy (a reduced-dose combination including rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) combined with acalabrutinib. The other group receives R-miniCHOP alone. The goal is to see whether the addition of acalabrutinib improves outcomes compared to standard treatment.
Investigational drugs: Acalabrutinib is a medication that blocks a specific protein called Bruton’s tyrosine kinase, which helps cancer cells grow and survive. By inhibiting this protein, acalabrutinib may help stop the progression of the lymphoma. Rituximab targets a protein on the surface of cancer cells, helping the immune system destroy them. R-miniCHOP is a combination of chemotherapy drugs that attack cancer cells in different ways, making it harder for the cancer to survive.
Study on Golcadomide for Patients with Relapsed or Refractory Large B-Cell Lymphoma in the Brain
This trial focuses on patients whose lymphoma has spread to the brain or central nervous system. It is specifically for those whose disease has either returned after treatment or has not responded to previous therapies.
Main inclusion criteria: Participants must be at least 18 years old with a diagnosis of secondary central nervous system lymphoma, or relapsed or refractory primary large B-cell lymphoma affecting the brain. For one group, patients must have received prior high-dose methotrexate-based chemotherapy. For another group, patients must have aggressive B-cell lymphoma that has progressed or relapsed with brain involvement confirmed by cerebrospinal fluid analysis, imaging, or biopsy. Patients need adequate blood counts (hemoglobin greater than 5 mmol/l, neutrophil count greater than 1.0×10⁹/l, platelet count greater than 75×10⁹/l) and a performance status of 2 or less.
Main exclusion criteria: The trial excludes patients with specific types of central nervous system lymphoma, though the exact exclusion criteria are limited in the source data.
Focus of the trial: The study evaluates how well golcadomide works in treating lymphoma that affects the brain. Researchers will monitor whether the medication can achieve complete or partial remission, how long the response lasts, and overall survival. The trial will also assess side effects, quality of life, and how the medication behaves in the body, particularly its levels in spinal fluid compared to blood.
Investigational drug: Golcadomide (CC-99282) is taken as an oral capsule. It works by interfering with specific pathways that cancer cells use to grow and survive, thereby inhibiting their multiplication. This medication is still investigational and not yet part of standard treatment, as it is being studied for its effectiveness in brain lymphomas.
Study on the Effectiveness and Safety of Cytarabine, Tafasitamab, and Lenalidomide for Patients with Relapsed Diffuse Large B-Cell Lymphoma
This trial investigates an innovative approach to treating patients whose lymphoma has returned after initial treatment. The study uses blood tests to detect tumor DNA, allowing doctors to start a second round of treatment early when signs of relapse appear.
Main inclusion criteria: Patients must have a diagnosis of diffuse large B-cell lymphoma or high-grade B-cell lymphoma and be eligible for chemotherapy treatments. They need to be at least 18 years old and have test results available, including mutation analysis and tumor DNA assessment from blood samples, as well as PET-CT scans from before and after first-line treatment. Patients must be in complete remission confirmed by PET-CT scan after completing their initial treatment. They need a performance status of 0-2 (or 3 if due to disease progression) and must agree to use effective contraception during and after the trial.
Main exclusion criteria: Patients with other types of cancer unrelated to the specified lymphomas cannot participate. Those who have not completed previous treatments or recovered from side effects, with severe heart problems, uncontrolled high blood pressure, active infections, pregnancy, breastfeeding, or allergic reactions to similar treatments are excluded. Patients unable to follow study procedures or attend required visits are also ineligible.
Focus of the trial: The study tests whether monitoring levels of tumor DNA in the blood can help identify early relapse and guide timely initiation of second-line treatment. This DNA-guided approach aims to catch cancer recurrence earlier than traditional methods. The trial evaluates the overall response rate to treatment and any significant side effects, while also assessing quality of life using questionnaires.
Investigational approach: The trial uses cell-free circulating tumor DNA detection as a biomarker to guide treatment decisions. When tumor DNA levels rise in the blood, indicating possible relapse, second-line treatment is started. This treatment may include various medications such as cytarabine, tafasitamab, lenalidomide, dexamethasone, cisplatin, bendamustine, polatuzumab vedotin, and rituximab, administered through oral tablets and intravenous infusions.
Summary
The three ongoing trials for diffuse large B-cell lymphoma stage IV represent different approaches to treating this aggressive cancer. One trial focuses on older adults who have not yet received treatment, testing whether adding a targeted therapy to standard chemotherapy improves outcomes. Another addresses the challenging situation of lymphoma affecting the brain, evaluating a novel oral medication for patients whose disease has relapsed or not responded to treatment. The third trial introduces an innovative DNA-guided approach for patients in remission after initial treatment, aiming to detect and treat relapse earlier than traditional methods.
Geographically, these trials are concentrated in Western and Central Europe, with studies taking place in Belgium, Germany, Greece, the Netherlands, and Poland. Each trial targets specific patient populations based on age, treatment history, and disease characteristics. The investigational treatments include targeted therapies that block specific proteins involved in cancer growth, as well as innovative monitoring approaches using tumor DNA in the blood.
Patients interested in participating should discuss with their healthcare providers whether they meet the specific criteria for any of these trials and whether participation might be appropriate for their individual situation.
