Ongoing Clinical Trials for Central Nervous System Lymphoma
There are currently 6 clinical trials ongoing for central nervous system lymphoma, testing various treatment combinations and imaging techniques across multiple European countries. These studies focus on patients with newly diagnosed disease, as well as those whose condition has relapsed or not responded to previous treatments.
Clinical trial locations
- Czechia
- Denmark
- Finland
- France
- Study on Golcadomide and Valemetostat Tosylate for Patients with Relapsed or Refractory Non-Hodgkin Lymphomas
- Study on the Safety of CA-4948 and Ibrutinib for Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma
- Study on [18F]-Fludarabine and Gadoteric Acid for Imaging in Patients with Newly Diagnosed Primary CNS Lymphoma
- Germany
- Italy
- Poland
- Spain
Study on Golcadomide and Valemetostat Tosylate for Patients with Relapsed or Refractory Non-Hodgkin Lymphomas
This trial is investigating a new medication called Golcadomide (also known as CC-99282), tested alone and in combination with other treatments including Rituximab, Obinutuzumab, Tafasitamab, and Valemetostat Tosylate. The study focuses on several types of Non-Hodgkin Lymphomas, including Primary Central Nervous System Lymphoma, that have returned or have not responded to previous treatments.
Inclusion criteria: Participants must be at least 18 years old and have a confirmed diagnosis of relapsed or refractory Non-Hodgkin’s Lymphoma, including Primary Central Nervous System Lymphoma. They need to have an ECOG performance status of 0, 1, or 2, which measures their ability to perform daily activities. Adequate blood counts are required, including an absolute neutrophil count of at least 1.5 x 10^9/L (or 1 x 10^9/L if bone marrow is involved), hemoglobin of at least 8 g/dL, and platelets of at least 75 x 10^9/L (or 50 x 10^9/L if bone marrow is involved). Liver and kidney function must be within acceptable ranges, and participants must agree to follow a pregnancy prevention plan.
Exclusion criteria: Patients with other types of cancer not listed in the study cannot participate. Those with serious health conditions that could interfere with the study, pregnant or breastfeeding women, and individuals who have had recent heart problems or active infections requiring treatment are excluded. People with a history of allergic reactions to the study drugs, those currently in another clinical trial, or those with a history of drug or alcohol abuse are also not eligible. Additionally, patients who have had major surgery within the last 4 weeks or who have HIV, hepatitis B, or hepatitis C cannot participate.
Focus: The trial aims to determine the safety and tolerability of Golcadomide when used alone and in combination with other treatments. Researchers will look for the best dose to use in future studies and evaluate the body’s processing of the medication and its preliminary effectiveness.
Investigational drugs: CC-99282 (Golcadomide) is an experimental oral medication being tested for treating relapsed or refractory lymphomas. Rituximab, Obinutuzumab, and Tafasitamab are monoclonal antibodies that help the immune system fight cancer. Valemetostat is another investigational drug being studied for its potential benefits in treating these conditions.
Study on Methotrexate, Tafasitamab, Lenalidomide, and Rituximab for Patients with Primary Central Nervous System Lymphoma Not Eligible for Stem Cell Transplant
This German study focuses on patients with Primary Central Nervous System Lymphoma who cannot undergo intensive therapies like stem cell transplantation. The trial tests a combination of four medications: Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®), and Rituximab.
Inclusion criteria: Participants must be between 18 and 69 years old with an ECOG performance status of 2 or higher, or 70 years or older and not eligible for stem cell transplant. They must have a newly diagnosed, untreated Primary Central Nervous System Lymphoma confirmed by a pathologist. At least one measurable tumor must be present. Adequate organ function is required, including kidney function with an estimated glomerular filtration rate of 60 ml/min or higher, liver enzymes less than 3 times the upper limit of normal, adequate blood counts, and heart function with ejection fraction of 40% or higher. Participants must provide written informed consent and agree to use effective contraception.
Exclusion criteria: Patients who are able to receive intensive induction and consolidation therapies are not eligible. Members of vulnerable populations, such as children or those unable to make informed decisions, are also excluded.
Focus: The study aims to find a practical and effective treatment plan for patients with this condition. Researchers will monitor how well the cancer responds after at least two treatment cycles and assess overall response after four cycles. They will also evaluate progression-free survival, overall survival, quality of life, cognitive function, and safety throughout the trial.
Investigational drugs: Methotrexate is given through infusion to slow or stop cancer cell growth. Tafasitamab is an antibody therapy that targets specific proteins on cancer cells. Lenalidomide is an oral medication that helps the immune system attack cancer cells. Rituximab is another antibody that targets cancer cells, marking them for destruction by the immune system.
Study on the Safety of CA-4948 and Ibrutinib for Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma
This multi-country trial is testing a combination of CA-4948, an experimental drug, with Ibrutinib, a medication already used to treat certain blood cancers. The study focuses on patients whose cancer has returned or did not respond to previous treatments.
Inclusion criteria: Participants must be 18 years or older with a life expectancy of at least 3 months. They need an ECOG Performance Status of 1 or less and must be able to swallow and retain oral medications. Adequate organ function is required, including white blood cell count of at least 3,000 per microliter, platelet count of at least 75,000 per microliter without transfusion, estimated creatinine clearance of at least 35 mL/min, hemoglobin of at least 9.0 g/dL, normal blood clotting tests, and acceptable liver enzyme levels. CPK levels must be less than 2.5 times the upper limit of normal. Participants must have recovered from previous cancer treatment side effects, agree to use effective birth control, and be able to provide informed consent. Those in Part B of the study must be able to tolerate certain medical procedures like lumbar punctures and MRI scans.
Exclusion criteria: Patients who do not meet the age requirements or who are considered part of vulnerable populations may be excluded. Part A2 of the study has closed enrollment for certain types of blood cancer that have relapsed or are refractory.
Focus: The trial aims to evaluate the safety and effects of combining CA-4948 with Ibrutinib. The study begins with a dose escalation phase to find the safest and most effective dose, then expands to include more patients. Researchers will monitor participants closely for side effects and changes in health, including regular MRI scans to track disease progress.
Investigational drugs: CA-4948 is an experimental oral medication being tested for safety and effectiveness. Ibrutinib blocks a protein that helps cancer cells grow and survive, and is combined with CA-4948 to potentially improve treatment outcomes.
Study on the Effectiveness of Etoposide Phosphate, Carboplatin, Methotrexate, Rituximab, and Cyclophosphamide in Patients with Primary Central Nervous System Lymphoma
This Finnish trial focuses on newly diagnosed patients or those whose disease has relapsed. The study explores a treatment approach combining chemotherapy and immunotherapy with a technique to open the blood-brain barrier, allowing medications to reach the brain more effectively.
Inclusion criteria: Patients must have Primary Central Nervous System Lymphoma, either newly diagnosed or relapsed after previous intravenous chemotherapy. The disease must be diffuse large B-cell lymphoma, a specific type of cancer affecting certain white blood cells. Participants must be between 18 and 70 years old for certain study groups, and between 71 and 75 years old for others. Written consent to participate is required.
Exclusion criteria: Patients with a different type of cancer than the one being studied, those outside the specified age range, or those unable to follow study procedures or attend follow-up visits are excluded. People with serious health conditions that might interfere with the study, pregnant or breastfeeding women, and those currently in another clinical trial cannot participate. Patients who have had recent major surgery, have a history of allergic reactions to the study medication, have substance abuse or alcohol dependency, or have an active infection requiring treatment are also excluded.
Focus: The trial will follow patients over time to assess survival at 2, 5, and 10 years after starting treatment. It will evaluate how well the cancer responds to treatment and monitor for side effects, particularly long-term effects on the nervous system.
Investigational drugs: The treatment includes Etoposide Phosphate, Carboplatin, Methotrexate, Rituximab, and Cyclophosphamide, all given through intravenous infusion. These medications work in different ways to stop cancer cell growth. The blood-brain barrier opening technique helps these drugs reach the brain more effectively.
Study on the Safety and Effectiveness of Berubicin for Patients with Central Nervous System Lymphomas
This Polish trial is evaluating Berubicin hydrochloride, an anthracycline drug, administered through intravenous infusion. The medication is tested in combination with other cancer-fighting drugs.
Inclusion criteria: Participants must be at least 18 years old and provide written informed consent. They need a confirmed diagnosis of lymphoma affecting the central nervous system, confirmed by a pathologist through tissue tests. Patients should not have received previous high-dose methotrexate-based chemotherapy, though those with non-Hodgkin’s lymphoma may have had up to two courses of R-CHOP treatment if they have advanced disease. No investigational therapy should have been received within 4 weeks before starting the study drug. An ECOG Performance Status of 0 to 3 is required, and patients must be eligible for chemotherapy based on adequate bone marrow, heart, kidney, and liver function. Women of childbearing potential and men must agree to use effective birth control during the study.
Exclusion criteria: The specific exclusion criteria focus on ensuring that only patients with central nervous system lymphomas who meet the inclusion requirements participate in the study.
Focus: The study aims to evaluate the safety and tolerability of Berubicin when used with other cancer-fighting drugs and to determine the best dose for future research. Researchers will monitor how long patients live without disease progression and assess how many respond positively to treatment. Regular check-ups and tests will track participants’ progress through early 2027.
Investigational drugs: Berubicin is being studied for its potential in treating central nervous system lymphomas. It is evaluated for safety and tolerability in combination with other cancer medications.
Study on [18F]-Fludarabine and Gadoteric Acid for Imaging in Patients with Newly Diagnosed Primary CNS Lymphoma
This French study uses a special imaging technique called PET-MRI to understand how [18F]fludarabine, a new imaging drug, is absorbed by the cancer. The drug is given through a vein as an infusion, along with gadoteric acid to improve MRI image quality.
Inclusion criteria: Patients must be 18 years or older with newly diagnosed high-grade central nervous system lymphoma, confirmed by cell or tissue tests. They should not have received any chemotherapy or radiotherapy for their lymphoma. A contrast-enhanced intracranial mass of at least 1 cm in size must be present. A Karnofsky index of 40 or higher is required, measuring the ability to perform everyday activities. Patients should not have systemic lymphoma as shown by FDG PET/CT scan. Creatinine clearance of 30 mL/min or higher is necessary, indicating adequate kidney function. Patients must be affiliated with social security and sign an informed consent form.
Exclusion criteria: Patients who have already had surgery, radiotherapy, or chemotherapy for their condition cannot participate. Those without a newly diagnosed primary central nervous system lymphoma or who fall outside the specified age range are excluded.
Focus: The study aims to understand how [18F]fludarabine spreads in the brain and how much is absorbed by the cancer before any surgery, chemotherapy, or radiotherapy begins. PET-MRI scans will measure the amount of the drug in the tumor compared to healthy tissue and look at other factors like tumor size and brain effects.
Investigational drugs: [18F]-Fludarabine is a special imaging agent used with PET-MR imaging to look at primary central nervous system lymphomas. Gadoteric acid is a contrast agent used to enhance MRI image quality.
Summary
The six ongoing clinical trials for central nervous system lymphoma reflect a diverse approach to treating this rare condition. Most studies focus on combination therapies, using multiple medications together to improve treatment outcomes. France appears in three trials, demonstrating a particular focus on this disease, while other trials are distributed across Denmark, Germany, Finland, Italy, Poland, Czechia, and Spain.
The trials can be broadly categorized into treatment studies and diagnostic imaging research. Treatment studies test various combinations of chemotherapy, immunotherapy, and targeted therapies, while one trial focuses on improving imaging techniques for better diagnosis and monitoring. Several studies specifically target patients whose disease has relapsed or not responded to previous treatments, addressing an important unmet medical need.
Notable medications appearing across multiple trials include Rituximab and Methotrexate, which are established treatments for lymphomas. The trials also investigate several experimental drugs, including Golcadomide, CA-4948, Tafasitamab, Lenalidomide, and Berubicin, reflecting ongoing efforts to find more effective treatment options for this challenging condition.
