Clinical Trials for Follicle Centre Lymphoma Follicular Grade I II III Refractory
There is currently 1 ongoing clinical trial for patients with relapsed or refractory follicular lymphoma. This trial is testing a new combination of treatments to improve outcomes for patients whose cancer has returned or not responded to previous therapy. The study is being conducted across multiple European countries and aims to evaluate the safety and effectiveness of adding a bispecific antibody to existing treatment regimens.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- France
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Poland
- Slovakia
- Spain
- Sweden
Study on the Safety and Effectiveness of Epcoritamab with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma
This clinical trial is investigating a new treatment approach for patients whose follicular lymphoma has either returned after treatment or has not responded to previous therapies. The study is testing whether adding a newer medication called epcoritamab to an existing treatment combination can improve outcomes for these patients.
Main inclusion criteria:
- Patients must have a confirmed diagnosis of classic follicular lymphoma at stages II, III, or IV, with the most recent biopsy showing the presence of a protein called CD20
- The disease must have relapsed or been refractory to at least one prior treatment that included an anti-CD20 antibody combined with chemotherapy
- Patients must have at least one measurable lesion: either a lymph node larger than 1.5 cm or a lesion outside the lymph nodes larger than 1.0 cm
- A positive FDG-PET scan that matches findings on CT or MRI scans is required
- Patients must have an ECOG performance status score of 0 to 2, meaning they can carry out daily activities with minimal to moderate limitations
- Patients must be eligible to receive the R2 treatment combination as determined by their doctor
- Both male and female patients are eligible
Main exclusion criteria:
- Patients with other types of cancer besides follicular lymphoma cannot participate
- Patients outside the specified adult age range are not eligible
- Vulnerable populations, such as those unable to give informed consent, cannot participate
- Patients with serious health conditions that might interfere with study treatment are excluded
- Pregnant or breastfeeding women are not eligible
- Patients who have had recent major surgery or are recovering from surgery cannot participate
- Those who have received certain treatments or medications that might interfere with the study drugs are excluded
- Patients with active infections or other medical conditions that could affect their safety during the study cannot participate
Focus and goal of the trial:
The primary goal of this study is to determine whether the combination of epcoritamab with rituximab and lenalidomide is both safe and more effective than rituximab and lenalidomide alone. The study will compare the effects of both treatment approaches by monitoring several important outcomes, including how long patients live without their cancer getting worse (known as progression-free survival), complete response rates, overall survival, and minimal residual disease negativity.
Participants will receive regular treatment according to a specific schedule and will undergo frequent monitoring and assessments throughout the study. The treatment involves lenalidomide taken as oral capsules, rituximab given through an intravenous infusion, and epcoritamab administered via subcutaneous injection. The study is expected to conclude by June 2030, and the results will contribute important information about this treatment approach for patients with relapsed or refractory disease.
Investigational drugs being tested:
Epcoritamab is a bispecific antibody, meaning it can bind to two different types of antigens to help the immune system better target and destroy cancer cells. It is administered as an injection under the skin and is being studied for its potential to improve treatment outcomes when added to existing therapies.
Rituximab is a monoclonal antibody that specifically targets a protein called CD20 found on the surface of certain immune cells called B-cells, which are often involved in lymphoma. By binding to this protein, rituximab helps the body destroy these cancer cells. It is given through an intravenous infusion and is already well-established as an effective treatment for various types of lymphoma.
Lenalidomide is an immunomodulatory drug that helps boost the immune system’s ability to fight cancer cells and also has anti-angiogenic properties, meaning it can prevent tumors from forming new blood vessels they need to grow. It is taken orally in capsule form and is commonly used in combination therapies for blood cancers.
Summary
Currently, there is one active clinical trial available for patients with relapsed or refractory follicular lymphoma across 14 European countries. This study represents an important research effort to improve treatment options for patients whose cancer has returned or not responded to standard therapies.
The trial is notably widespread, being conducted in Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Slovakia, Spain, and Sweden. This broad geographic distribution increases access for European patients to potentially beneficial new treatment approaches.
The study focuses on combining a promising new bispecific antibody, epcoritamab, with two established medications, rituximab and lenalidomide. This approach reflects current research trends in cancer treatment that aim to harness the immune system more effectively to fight cancer. The trial’s design, which compares the new three-drug combination against the existing two-drug combination, will provide valuable evidence about whether adding epcoritamab offers additional benefit to patients.