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Study on Glofitamab, Venetoclax, and Zanubrutinib for Patients with Untreated or Relapsed High-Risk Mantle Cell Lymphoma

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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 Mantle-Cell Lymphoma, which is a rare form of non-Hodgkin's lymphoma. The study is exploring the effectiveness of different treatment combinations for patients who have either not been treated before or have a form of the disease that has returned or is resistant to previous treatments. The treatments being tested include a combination of medications: Glofitamab, Venetoclax, and Zanubrutinib. Glofitamab is given as an infusion, which means it is administered directly into the bloodstream through a vein, while Venetoclax and Zanubrutinib are taken orally as tablets or capsules.

The purpose of the study is to evaluate how well these treatments work in managing high-risk Mantle-Cell Lymphoma. Participants in the study will receive one of the treatment combinations and will be monitored over a period to see how their disease responds. The study will involve regular visits to the clinic for treatment and check-ups, which may include imaging tests to assess the progress of the disease. The study aims to determine the effectiveness of these treatments in controlling the disease and improving patient outcomes.

Throughout the study, participants will be closely observed for any side effects or changes in their condition. The study will help researchers understand the potential benefits and risks of these treatment combinations for Mantle-Cell Lymphoma. The information gathered from this study could contribute to developing better treatment strategies for this type of cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, physical examination, and necessary laboratory tests.
Eligibility criteria include age, health status, and specific medical conditions related to mantle-cell lymphoma.
Step 2
Treatment initiation
The treatment phase begins with the administration of the first dose of glofitamab through an intravenous infusion. Hospitalization is required for monitoring during this initial administration.
The treatment regimen may include a combination of venetoclax (oral), zanubrutinib (oral), and glofitamab (intravenous), or venetoclax alone, depending on the specific cohort.
Step 3
Ongoing treatment
The treatment continues with regular administration of the medications. Venetoclax is taken orally, while glofitamab is administered intravenously.
The frequency and dosage of each medication are determined by the study protocol and may vary based on individual response and tolerance.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the effectiveness of the treatment and to manage any side effects. This includes imaging studies, blood tests, and clinical evaluations.
The primary goal is to evaluate the progression-free survival at 12 months, along with other response rates and overall survival.
Step 5
Completion of treatment
The treatment phase concludes after a specified period, typically around 17 cycles, unless adjustments are made based on individual response.
Final assessments are conducted to evaluate the overall response to the treatment and to plan any necessary follow-up care.

Who can join the trial?

17 criteria

Must be between 18 and 79 years old.
Women who can have children must have a negative pregnancy test before starting the study and agree not to become pregnant or breastfeed during the study and for a certain period after.
Men who can father children must agree to use birth control and not donate sperm during the study and for a certain period after.
Must have enough healthy blood cells, as shown by specific blood tests.
Must be part of a social security system.
Must understand and speak one of the official languages of the country.
Must have a COVID-19 vaccination status that follows local guidelines.
Must be willing to stay in the hospital when required and follow all study procedures.
Any side effects from previous cancer treatments must be mild or gone.
For certain groups, must have specific conditions related to previous treatments or disease progression.
Must have a confirmed diagnosis of **Mantle-Cell Lymphoma** through specific tests.
Must have a measurable disease, meaning the cancer can be seen and measured on a scan.
Must have cancer that is at stage II to IV.
Must be able to perform daily activities with little to moderate difficulty, as measured by a specific scale called **ECOG performance status**.
Must have a life expectancy of more than 3 months.
Must have good kidney function, shown by a specific test.
Must have good liver function, unless affected by the lymphoma.

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Verified sites

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

Az St-Jan Brugge-Oostende A.V.
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Brugge, Belgium
Centre Henri Becquerel
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Rouen, France
Centre Hospitalier Lyon Sud
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Pierre Benite, France

Trial locations

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Investigated drugs

Glofitamab
is a medication being studied for its potential to treat high-risk Mantle Cell Lymphoma. It is used in combination with other drugs to see if it can help control or reduce the cancer in patients who have not responded to other treatments or are newly diagnosed.
Venetoclax
is a medication that helps to kill cancer cells by targeting a specific protein that helps them survive. In this trial, it is used either alone or in combination with other medications to treat patients with high-risk Mantle Cell Lymphoma.
Zanubrutinib
is a medication that works by blocking certain signals that cancer cells need to grow. It is being tested in combination with other drugs to determine if it can improve outcomes for patients with high-risk Mantle Cell Lymphoma.

What is already known about the treatment

Glofitamab
This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating mantle-cell lymphoma, a type of cancer. It is an investigational drug, meaning it is not yet approved for general medical use. Glofitamab works by targeting specific proteins on cancer cells, helping the immune system to recognize and destroy these cells. It is classified as a bispecific monoclonal antibody.
Venetoclax
This medication is taken orally in pill form and is used in the treatment of certain types of blood cancers, including mantle-cell lymphoma. It is approved for medical use and is well-documented in medical literature. Venetoclax works by inhibiting a protein that helps cancer cells survive, leading to their death. It belongs to a class of drugs known as BCL-2 inhibitors.
Zanubrutinib
This medication is administered orally and is used to treat mantle-cell lymphoma. It is approved for use in some countries and is being further studied in clinical trials. Zanubrutinib works by blocking a protein that helps cancer cells grow and divide, thereby slowing down or stopping the progression of the disease. It is classified as a Bruton's tyrosine kinase (BTK) inhibitor.

Investigated diseases

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It typically begins in the outer edge of a lymph node called the mantle zone. The disease often progresses by spreading to other lymph nodes, bone marrow, and sometimes the spleen or gastrointestinal tract. Patients may experience symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression can vary, with some cases advancing slowly while others may progress more rapidly.