Ongoing Clinical Trials for Epstein-Barr Virus Associated Lymphoma
This article provides information about 2 ongoing clinical trials investigating new treatments for Epstein-Barr virus associated lymphoma. These studies are testing different medication combinations to help patients whose disease has returned or not responded to standard treatments, as well as those with newly diagnosed high-risk forms of the disease.
Clinical trial locations
- Austria
- Bulgaria
- Czechia
- Denmark
- Finland
- France
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Spain
- Sweden
Study on Golcadomide and R-CHOP Drug Combination for Patients with Untreated High-risk Large B-cell Lymphoma
This clinical trial is investigating whether adding a new medication called golcadomide to a standard chemotherapy treatment can help patients with high-risk large B-cell lymphoma. The study is designed to compare two treatment groups: one receiving golcadomide plus R-CHOP chemotherapy, and another receiving a placebo plus R-CHOP chemotherapy.
Main inclusion criteria:
- Adults between 18 and 80 years old
- Confirmed diagnosis of large B-cell lymphoma that has not been treated before
- At least one measurable tumor larger than 1.5 cm
- Specific risk scores indicating high-risk disease
- Good enough blood counts, liver function, and kidney function to safely receive treatment
- Ability to perform daily activities with minimal limitations
Main exclusion criteria:
- Having a different type of cancer than the one being studied
- Being pregnant or breastfeeding
- Having other medical conditions that might interfere with the study
- Recent participation in another clinical trial
- Allergies or reactions to the study medications
- Inability to provide informed consent or follow study procedures
Focus of the trial: The main goal of this study is to measure how long patients can live without their disease getting worse, known as progression-free survival. Researchers will also look at overall survival rates and whether the cancer completely responds to treatment. The study is double-blind, meaning neither participants nor researchers will know who is receiving the new treatment or the placebo until the study is complete.
Investigational drugs: Golcadomide is an experimental medication being tested to see if it can improve outcomes when combined with R-CHOP chemotherapy. R-CHOP is a standard treatment consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. These medications are given in cycles, with each cycle lasting 21 days. Participants will receive regular monitoring through blood tests, imaging studies, and physical examinations throughout the treatment period.
Study on Nanatinostat and Valganciclovir for Patients with Epstein-Barr Virus-Positive Relapsed or Refractory Lymphomas
This clinical trial is testing a combination of two medications, nanatinostat and valganciclovir, for patients whose Epstein-Barr virus-positive lymphoma has either returned after treatment or has not responded to previous treatments. The study aims to determine if this combination can help reduce tumor size or slow disease progression.
Main inclusion criteria:
- Adults aged 18 years or older (patients with certain types of lymphoma may be as young as 12 years)
- Confirmed Epstein-Barr virus-positive lymphoma that has returned or not responded to at least two previous treatments
- Previous treatment must have included anti-CD20 immunotherapy and anthracycline-based chemotherapy
- Measurable disease according to standard assessment criteria
- No other available treatment options that would be more appropriate
- Not eligible for advanced treatments like stem cell transplantation or CAR-T therapy
- Adequate bone marrow function
Main exclusion criteria:
- Having lymphoma not associated with the Epstein-Barr virus
- Being outside the specified age range
- Being pregnant or breastfeeding
- Having other medical conditions that could interfere with the study or make participation unsafe
- Participating in another clinical trial at the same time
- Inability to follow study procedures or take medications as required
Focus of the trial: The primary goal is to assess the objective response rate, which measures how well tumors respond to the treatment combination. Secondary goals include measuring how long the response lasts, the time until additional treatment is needed, progression-free survival, and overall survival. The study will also monitor how the body processes these medications.
Investigational drugs: Nanatinostat is an experimental medication that works by inhibiting specific enzymes that modify DNA structure, which can help stop cancer cell growth. It is taken orally as coated tablets. Valganciclovir is an antiviral medication that interferes with viral DNA replication. While valganciclovir is already used to treat certain viral infections, its use in combination with nanatinostat for lymphoma treatment is investigational. Both medications are taken by mouth, and patients receive regular assessments to evaluate treatment effectiveness and monitor for side effects.
Summary
Two clinical trials are currently recruiting patients with Epstein-Barr virus associated lymphoma across multiple European countries. The first trial is available in 17 countries and focuses on newly diagnosed high-risk disease, testing whether adding golcadomide to standard chemotherapy can improve outcomes. The second trial, available in 4 countries, addresses patients whose disease has returned or not responded to treatment, investigating a combination of nanatinostat and valganciclovir.
Both trials are testing novel medication combinations and represent different approaches to treating this challenging disease. France, Germany, Italy, and Spain are participating in both studies, offering patients more options depending on their disease stage and treatment history. These trials reflect ongoing efforts to develop new treatment strategies for patients with limited options under current standard care.
