Study Comparing Odronextamab and Lenalidomide with Rituximab and Lenalidomide for Patients with Relapsed/Refractory Follicular and Marginal Zone Lymphoma
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 aims to compare the effectiveness and safety of two different treatment combinations. One group of participants will receive a combination of odronextamab (also known by its code name REGN1979) and lenalidomide, while the other group will receive rituximab combined with lenalidomide. Odronextamab is a type of medication called a bispecific antibody, which is designed to target specific proteins on cancer cells, while rituximab is a monoclonal antibody that also targets cancer cells.
The purpose of the study is to determine which combination works better in treating these types of lymphomas. Participants will be randomly assigned to one of the two treatment groups. The study will begin with a phase to ensure the safety and tolerability of the odronextamab and lenalidomide combination. Following this, the main phase will compare the two treatment combinations to see which is more effective in preventing the cancer from getting worse. This will be assessed by looking at how long participants live without their disease progressing, known as progression-free survival.
Throughout the study, participants will receive their assigned treatments and will be monitored regularly to assess the effects of the treatments and any side effects. The study is expected to last for several years, allowing researchers to gather enough information to make a clear comparison between the two treatment options. This research is important for finding better ways to treat follicular lymphoma and marginal zone lymphoma, potentially improving outcomes for patients with these conditions.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of follicular lymphoma or marginal zone lymphoma, previous treatment history, and overall health status.
2part 1: safety run-in
This initial phase focuses on assessing the safety and tolerability of the combination of odronextamab and lenalidomide.
Participants receive odronextamab through an intravenous infusion. The dosage and frequency are determined by the study protocol.
Participants also take lenalidomide orally in the form of capsules. The dosage may vary, including 20 mg, 10 mg, or 5 mg, as specified by the study protocol.
The primary goal is to identify any dose-limiting toxicities and treatment-related side effects.
3part 2: randomized phase
Participants are randomly assigned to one of two treatment groups.
One group receives odronextamab in combination with lenalidomide, while the other group receives rituximab in combination with lenalidomide.
Rituximab is administered intravenously, with dosages of either 100 mg or 500 mg, as per the study protocol.
The effectiveness of each treatment combination is compared, focusing on progression-free survival, which measures the time during and after treatment that the disease does not worsen.
4monitoring and assessments
Throughout the trial, regular monitoring and assessments are conducted to evaluate the response to treatment and any side effects.
This includes blood tests, imaging studies such as CT or MRI scans, and other evaluations as required by the study protocol.
Participants’ overall health and quality of life are also assessed using various questionnaires.
5end of treatment
The trial is expected to continue until April 2029, with individual participation duration varying based on response to treatment and other factors.
Upon completion of the treatment phase, participants undergo final assessments to determine the overall outcome and any long-term effects.
Who Can Join the Study?
The patient must have a confirmed diagnosis of Follicular Lymphoma (FL) grade 1-3a or Marginal Zone Lymphoma (MZL), which can be in the lymph nodes, spleen, or other areas outside the lymph nodes.
The patient must have a disease that has not responded to treatment (refractory) or has returned (relapsed) after at least one previous treatment that included a combination of chemotherapy and immunotherapy. This previous treatment must have included a specific type of medicine called an anti-CD20 antibody.
The patient must have a disease that can be measured using imaging tests like CT scans or MRI scans.
The patient must have an ECOG performance status of 0 to 2, which is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, while 2 means the patient is up and about more than half of the day but may not be able to work.
The patient must have adequate blood and organ function, meaning their blood counts and organ tests are within acceptable limits.
Other specific criteria defined in the study protocol may also apply.
Who Cannot Join the Study?
Patients who have a different type of cancer than the ones being studied cannot participate.
Patients who have not experienced a return or worsening of their lymphoma after treatment are not eligible.
Patients who are not within the specified age range for the study cannot join.
Patients who are part of a vulnerable population, meaning they might need special protection, are not included.
Patients who have other serious health conditions that could interfere with the study are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have had certain treatments recently that might affect the study results are not eligible.
Patients who are unable to follow the study procedures or attend required visits are excluded.
Odronextamab (REGN1979) is a type of medication known as a bispecific antibody. It is designed to target and bind to two different proteins, CD20 and CD3, which are found on certain immune cells. This helps the immune system to recognize and attack cancer cells in patients with follicular lymphoma and marginal zone lymphoma.
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. It is used in combination with other medications to treat certain types of lymphoma.
Rituximab is a medication that targets a specific protein called CD20 found on the surface of certain cancer cells. By binding to this protein, rituximab helps the immune system to destroy these cancer cells. It is used in combination with lenalidomide to treat certain types of lymphoma.
Relapsed/Refractory Follicular Lymphoma – This is a type of non-Hodgkin lymphoma that originates from B-lymphocytes, a kind of white blood cell. It is characterized by the recurrence or persistence of the disease after initial treatment. The disease typically progresses slowly, often presenting with painless swelling of lymph nodes. Over time, it may spread to other parts of the body, including the bone marrow and spleen. Patients may experience symptoms such as fatigue, night sweats, and weight loss. The disease is considered indolent, meaning it progresses at a slower rate compared to more aggressive forms of lymphoma.
Relapsed/Refractory Marginal Zone Lymphoma (MZL) – This is a type of non-Hodgkin lymphoma that affects the marginal zone of lymphoid tissue, which is part of the immune system. It is termed “relapsed/refractory” when the disease returns after treatment or does not respond to initial therapy. MZL can develop in various parts of the body, including the spleen, lymph nodes, and mucosal tissues. The disease often progresses slowly, and symptoms may include swollen lymph nodes, abdominal discomfort, and fatigue. As it advances, it can affect other organs and tissues. MZL is generally considered an indolent lymphoma, with a gradual progression over time.
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