This clinical trial is focused on studying two types of blood cancers: follicular lymphoma and marginal zone lymphoma. These are conditions where the body’s lymphatic system, which is part of the immune system, is affected. The study is testing the effectiveness of a combination of medications to treat these diseases. The medications being studied include tafasitamab, lenalidomide, and rituximab. Tafasitamab is a type of protein that helps the immune system target cancer cells, while lenalidomide is a drug that affects the immune system and helps slow the growth of cancer cells. Rituximab is another medication that targets specific cells in the immune system. The study will compare the effects of these medications together against a combination of lenalidomide and rituximab alone.
The purpose of the study is to see if adding tafasitamab to the treatment makes it more effective for patients whose cancer has returned or has not responded to previous treatments. Participants in the study will receive either the combination of tafasitamab, lenalidomide, and rituximab or a combination of lenalidomide and rituximab, along with a placebo. The study will monitor the participants over a period to see how well the cancer responds to the treatment and to check for any side effects.
Throughout the study, participants will receive the medications through different methods. Tafasitamab and rituximab are given as an infusion, which means they are delivered directly into the bloodstream through a vein. Lenalidomide is taken orally in the form of capsules. The study aims to provide valuable information on whether the addition of tafasitamab can improve treatment outcomes for patients with these types of lymphoma.
1joining the study
Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving the study treatment or the placebo.
2initial treatment phase
If you are in the group receiving the study treatment, you will receive rituximab through an intravenous infusion. This means the medication will be given directly into your vein. The dosage is 100 mg, and the frequency and duration will be determined by the study protocol.
You will also take lenalidomide in the form of hard capsules. The dosage may vary, including 5 mg, 10 mg, 15 mg, or 20 mg capsules, taken orally. The specific dosage and frequency will be provided by the study team.
3additional treatment phase
In addition to rituximab and lenalidomide, you may receive tafasitamab if you are in the study treatment group. Tafasitamab is administered as a 200 mg solution for infusion, given intravenously.
The duration and frequency of these treatments will be specified by the study protocol and communicated to you by the study team.
4placebo group
If you are in the placebo group, you will receive a saline solution infusion. This is a 0.9% sodium chloride solution, which is a standard saltwater solution used in medical settings. It will be administered in a similar manner to the study medications.
5monitoring and follow-up
Throughout the study, your health and response to the treatment will be closely monitored. This includes regular check-ups, blood tests, and other assessments as required by the study protocol.
The study team will provide you with all necessary information regarding the schedule and procedures for these follow-up visits.
6end of study
At the end of the study, you will undergo a final evaluation to assess your overall health and the effects of the treatment. The study team will discuss the results with you and provide any necessary follow-up care or recommendations.
Who Can Join the Study?
Participants must be at least 18 years old.
Participants must have a confirmed diagnosis of follicular lymphoma (FL) or marginal zone lymphoma (MZL). MZL can be nodal, splenic, or extranodal.
Participants must have been treated before with at least one type of systemic anti-CD20 immunotherapy or chemo-immunotherapy. This includes treatments like rituximab alone or chemotherapy combined with immunotherapy such as rituximab or obinutuzumab, with or without additional maintenance therapy.
Participants must have documented relapsed, refractory, or progressive disease after treatment with systemic therapy:
Relapsed lymphoma: The disease returned after an initial response of complete or partial remission that lasted at least 6 months after previous therapy.
Refractory lymphoma: The disease did not respond well to the last treatment or the response lasted less than 6 months.
Progressive lymphoma: The disease worsened after an initial response of stable disease to previous therapy.
Who Cannot Join the Study?
Patients with other types of cancer that are not follicular lymphoma (FL) or marginal zone lymphoma (MZL) cannot participate.
Patients who have not experienced a return or worsening of their lymphoma after treatment, known as relapsed/refractory (R/R), are not eligible.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which may include those unable to give informed consent, are not eligible.
Patients who are not able to take the study medications safely cannot participate.
Patients with certain medical conditions that could interfere with the study treatment or outcomes are not eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Tafasitamab is a type of medication that helps the immune system find and destroy cancer cells. It works by attaching to a specific protein found on the surface of certain cancer cells, making it easier for the body’s natural defenses to target and eliminate them. In this trial, tafasitamab is being tested to see if it can help treat certain types of lymphoma, which is a cancer of the lymphatic system.
Lenalidomide is a medication that helps the immune system fight cancer. It works by affecting the way the immune system functions, which can help slow down or stop the growth of cancer cells. Lenalidomide is used in this trial to see if it can improve the treatment of lymphoma when used with other medications.
Rituximab is a medication that targets specific cells in the immune system. It works by attaching to a protein on the surface of certain white blood cells, which can help destroy these cells when they are cancerous. Rituximab is commonly used to treat different types of lymphoma, and in this trial, it is being used to see if it can enhance the effectiveness of other treatments for lymphoma.
Follicular Lymphoma – Follicular lymphoma is a type of non-Hodgkin lymphoma that originates from B-lymphocytes, a kind of white blood cell. It typically progresses slowly and is characterized by the formation of tumors in the lymph nodes. Over time, it can spread to other parts of the body, including the bone marrow and spleen. The disease often presents with painless swelling of lymph nodes, fatigue, and sometimes fever or night sweats. As it advances, it may lead to more significant symptoms due to the involvement of multiple lymph nodes and organs. The progression can vary, with periods of stability followed by more active phases.
Marginal Zone Lymphoma – Marginal zone lymphoma is a type of non-Hodgkin lymphoma that arises from B-cells in the marginal zone of lymphoid tissue. It generally progresses slowly and can occur in various forms, including extranodal, nodal, and splenic types. The disease often presents with symptoms such as swollen lymph nodes, fatigue, and sometimes abdominal discomfort if the spleen is involved. It can spread to other lymphoid tissues and organs over time. The progression is typically indolent, with long periods of minimal symptoms. However, it can transform into a more aggressive form of lymphoma in some cases.
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