Not recruitingRare disease

Study of Mosunetuzumab and Zanubrutinib for Patients with Relapsed or Refractory Follicular Lymphoma

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called follicular lymphoma, which is a form of non-Hodgkin lymphoma. The study involves two treatments: Mosunetuzumab and Zanubrutinib. Mosunetuzumab is given as a solution for injection, while Zanubrutinib is provided in the form of hard capsules. The purpose of the study is to assess how effective these treatments are when used together in patients whose follicular lymphoma has returned or has not responded to previous treatments.

Participants in the study will receive both Mosunetuzumab and Zanubrutinib. Mosunetuzumab is administered through an injection under the skin, known as subcutaneous use, and Zanubrutinib is taken orally as a capsule. The study will monitor the effects of these medications over a period of time to see how well they work in treating the lymphoma. Some participants may receive a placebo, which is a substance with no active medication, to compare the results.

The trial will follow participants to observe the response of their lymphoma to the treatment, including any changes in the size of the cancer and overall health outcomes. The study aims to provide valuable information on the potential benefits of combining these two treatments for people with relapsed or refractory follicular lymphoma. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather data on the effectiveness of the treatment combination.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will begin by providing informed consent. This involves understanding the study's requirements and agreeing to participate.
The patient must meet specific health criteria, including adequate blood counts, kidney and liver function, and the ability to swallow capsules.
Step 2
Treatment initiation
The treatment involves two medications: zanubrutinib and mosunetuzumab.
Zanubrutinib is administered orally in the form of 80 mg hard capsules.
Mosunetuzumab is given as a solution for injection under the skin (subcutaneous use).
Step 3
Treatment schedule
The patient will follow a specific schedule for taking these medications, which will be explained in detail by the healthcare provider.
The duration and frequency of administration will be determined based on the study protocol and the patient's response to treatment.
Step 4
Monitoring and assessments
Throughout the trial, the patient's health and response to treatment will be closely monitored.
Regular assessments will be conducted to evaluate the effectiveness of the treatment and to identify any side effects.
Step 5
Completion of treatment
At the end of the treatment period, the patient's response will be evaluated according to specific criteria.
The primary goal is to assess the complete response rate at the end of the combination therapy.
Step 6
Follow-up
After completing the treatment, the patient will continue to be monitored for any long-term effects or recurrence of the disease.
The follow-up period will help determine the overall success of the treatment and any necessary next steps.

Who can join the trial?

16 criteria

Must be able to provide written consent and understand the study requirements.
Must have adequate blood counts, which means having enough white blood cells, platelets, and hemoglobin.
Must have good kidney function, which is measured by how well the kidneys can filter waste from the blood.
Must have good liver function, which is checked by specific blood tests.
Must be able to attend study visits and follow the study rules.
Must be able to swallow pills or capsules.
Women must either be unable to become pregnant or use effective birth control methods if they can become pregnant. They must also have a negative pregnancy test before starting the study.
Men must agree to use birth control methods during the study and for a short time after.
Must have a confirmed diagnosis of **follicular lymphoma**, a type of blood cancer.
Must be 18 years or older.
Must have a disease that has come back or not responded to previous treatments.
Must have had one to three previous treatments that included a specific type of antibody therapy.
Must need treatment based on the size of the tumor or specific criteria used by doctors.
Must have a performance status of 2 or less, which means being able to carry out daily activities with some limitations.
Must have tissue samples available for review, although this is not required to start treatment.
Must have at least one area of disease that can be measured or evaluated using a CT scan or PET scan. MRI is allowed if a CT scan cannot be done.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer other than follicular lymphoma cannot participate. Follicular lymphoma is a type of blood cancer that affects the lymphatic system.
Patients who are not experiencing a return or worsening of their follicular lymphoma, known as relapsed/refractory, are excluded. Relapsed means the cancer has come back, and refractory means it has not responded to treatment.
Patients who are younger than 18 years old or older than 65 years old are not eligible.
Patients who belong to vulnerable populations, such as those who cannot make decisions for themselves, are not included.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Responsive
Palermo, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

Trial locations

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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 in treating patients with follicular lymphoma that has returned or not responded to previous treatments.
Zanubrutinib
is a medication that belongs to a class of drugs called Bruton's tyrosine kinase (BTK) inhibitors. It works by blocking a specific protein that helps cancer cells grow and survive. This trial is exploring how well zanubrutinib works in combination with mosunetuzumab for patients with relapsed or refractory follicular lymphoma.

What is already known about the treatment

Mosunetuzumab
This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory follicular lymphoma. It is a bispecific antibody that targets CD20 on B-cells and CD3 on T-cells, helping the immune system to attack cancer cells. Mosunetuzumab is classified as an immunotherapy agent and is gaining attention in medical literature for its potential in treating certain types of lymphoma.
Zanubrutinib
This medication is taken orally and is also under investigation in clinical trials for relapsed or refractory follicular lymphoma. It works by inhibiting Bruton's tyrosine kinase (BTK), a protein that plays a crucial role in the growth and survival of B-cells, thereby helping to slow down or stop the progression of cancer. Zanubrutinib is classified as a targeted therapy and is recognized in medical literature for its potential benefits in treating B-cell malignancies.

Investigated diseases

Follicular lymphoma – Follicular lymphoma is a type of non-Hodgkin lymphoma that typically arises from B-lymphocytes, a kind of white blood cell. It is characterized by slow growth and often presents with painless swelling of lymph nodes. The disease can progress over time, sometimes transforming into a more aggressive form of lymphoma. Patients may experience symptoms such as fatigue, night sweats, and weight loss as the disease advances. Follicular lymphoma is often diagnosed in later stages due to its indolent nature. The progression of the disease can vary greatly among individuals, with some experiencing long periods of stability.