Study on Mosunetuzumab and Lenalidomide for Untreated Follicular Lymphoma Patients

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What is this study about?

This clinical trial is focused on studying a type of cancer called follicular lymphoma, which is a slow-growing form of non-Hodgkin lymphoma. The study is evaluating a treatment that combines a medication called Mosunetuzumab with another drug named lenalidomide. Mosunetuzumab is a type of medication known as a bi-specific monoclonal antibody, which is designed to help the immune system target and destroy cancer cells. Lenalidomide is a drug that can modify the immune system and is often used in cancer treatment.

The purpose of this study is to compare the effectiveness and safety of the combination of Mosunetuzumab and lenalidomide against another treatment that uses an anti-CD20 monoclonal antibody along with chemotherapy. Participants in the study will receive either the new combination treatment or the standard treatment, which includes the anti-CD20 monoclonal antibody and chemotherapy. The study will help determine which treatment is more effective for patients with previously untreated follicular lymphoma.

During the study, participants will receive their assigned treatment and be monitored for their response to the therapy and any side effects they may experience. The study aims to provide valuable information that could improve treatment options for people with follicular lymphoma. The trial is expected to continue for several years to gather comprehensive data on the treatments being tested.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Consent will be obtained to ensure understanding and agreement to participate.

2 initial assessment

An initial assessment will be conducted to evaluate the patient’s health status and eligibility for the trial. This may include physical examinations and laboratory tests.

3 treatment phase

The patient will receive mosunetuzumab, a solution for injection administered subcutaneously. The dosage and frequency will be determined by the study protocol.

The treatment will be compared to another regimen involving an anti-CD20 monoclonal antibody plus chemotherapy. The specific details of the comparison treatment will be provided during the trial.

4 monitoring and follow-up

Regular monitoring will occur throughout the trial to assess the patient’s response to treatment and any side effects. This will involve scheduled visits and tests as outlined in the study protocol.

5 completion of the trial

Upon completion of the treatment phase, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

  • Participants must be within the age range of 18 to 65 years old.
  • Both females and males are eligible to participate.
  • The study does not include individuals from vulnerable populations, which means people who might need special protection or care.

Who Cannot Join the Study?

  • Patients who are currently pregnant or breastfeeding cannot participate.
  • Individuals with a history of severe allergic reactions to any of the study medications are excluded.
  • Patients with uncontrolled high blood pressure, which means their blood pressure is not well-managed, are not eligible.
  • People with serious heart conditions, such as heart failure or recent heart attack, cannot join the study.
  • Individuals with severe liver or kidney disease, meaning their liver or kidneys are not working properly, are excluded.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible.
  • Individuals with a history of drug or alcohol abuse in the past year cannot participate.
  • Patients with any other medical condition that the study doctors believe would make participation unsafe are excluded.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Rrnav Anderlecht Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.04.2024

Trial locations

Investigated drugs:

Mosunetuzumab is a type of medication known as a monoclonal antibody. It is designed to help the immune system recognize and attack cancer cells. In this trial, it is being tested for its effectiveness and safety in treating follicular lymphoma, a type of blood cancer.

Lenalidomide is a medication that helps the immune system fight cancer and can also stop the growth of cancer cells. It is used in this trial to see how well it works in combination with mosunetuzumab for treating follicular lymphoma.

Anti-CD20 Monoclonal Antibody is a type of medication that targets a specific protein found on the surface of certain cancer cells. It helps the immune system destroy these cells. In this trial, it is being compared to the combination of mosunetuzumab and lenalidomide to evaluate its effectiveness in treating follicular lymphoma.

Chemotherapy refers to a group of medications that are used to kill or stop the growth of cancer cells. In this trial, chemotherapy is being used in combination with an anti-CD20 monoclonal antibody to compare its effectiveness against the combination of mosunetuzumab and lenalidomide in treating follicular lymphoma.

Investigated diseases:

Diabetes Mellitus – A chronic condition characterized by high levels of sugar in the blood. It occurs when the body cannot produce enough insulin or effectively use the insulin it produces. Over time, high blood sugar levels can lead to damage to various organs and tissues. Symptoms may include increased thirst, frequent urination, and fatigue. The disease can progress to complications affecting the heart, eyes, kidneys, and nerves. Management involves lifestyle changes and monitoring blood sugar levels.

Hypertension – A condition where the force of the blood against the artery walls is consistently too high. It often develops over many years and can lead to serious health problems if left unmanaged. Symptoms are usually not noticeable, which is why it is often called a “silent killer.” Over time, it can cause damage to the heart, blood vessels, and other organs. Risk factors include age, genetics, and lifestyle choices. Regular monitoring and lifestyle adjustments are crucial for managing this condition.

Asthma – A respiratory condition marked by spasms in the bronchi of the lungs, causing difficulty in breathing. It is usually connected to allergic reactions or other forms of hypersensitivity. Symptoms include wheezing, coughing, chest tightness, and shortness of breath. The severity of symptoms can vary and may be triggered by exercise, allergens, or respiratory infections. Asthma can be managed by avoiding triggers and using prescribed medications. Regular monitoring and a personalized action plan are essential for control.

Osteoarthritis – A degenerative joint disease characterized by the breakdown of cartilage and underlying bone. It commonly affects the knees, hips, and hands, leading to pain and stiffness. The condition progresses slowly, with symptoms worsening over time. Risk factors include age, obesity, joint injuries, and genetics. It can limit daily activities and reduce the quality of life. Management focuses on maintaining joint function and reducing pain.

Chronic Obstructive Pulmonary Disease (COPD) – A group of lung diseases that block airflow and make breathing difficult. It includes emphysema and chronic bronchitis, often caused by long-term exposure to irritating gases or particulate matter, most commonly from cigarette smoke. Symptoms include breathing difficulty, cough, mucus production, and wheezing. The disease progresses over time, leading to decreased lung function. Lifestyle changes and avoiding lung irritants are important for managing symptoms.

Trial ID:
2023-509510-11-00
Protocol code:
MO44842
Trial Phase:
Therapeutic confirmatory (Phase III)

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