Not recruitingRare disease

Study on the Effectiveness of Polatuzumab, Bendamustine, and Rituximab for Patients with Relapsed or Refractory Mantle Cell 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 the effectiveness of a treatment combination for patients with mantle cell lymphoma, a type of cancer that affects the lymph nodes. The treatment being tested includes three medications: Polatuzumab Vedotin, Bendamustine Hydrochloride, and Rituximab. These medications are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well this combination of medications works in patients whose mantle cell lymphoma has returned or has not responded to previous treatments. The study will involve several cycles of treatment, and the response to the treatment will be assessed at different stages. The study aims to determine the best response rate, which refers to how well the cancer responds to the treatment, either during the middle of the treatment or at the end of the treatment period.

Participants in the study will receive the treatment over a period of time, with regular assessments to monitor their response and any side effects. The study will help to understand the safety and effectiveness of this treatment combination for mantle cell lymphoma. The trial is expected to continue until 2026, providing valuable information on the potential benefits of these medications for patients with this type of cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be asked to provide written consent, confirming your understanding of the study's purpose and your willingness to participate.
You must be at least 18 years old and have a confirmed diagnosis of relapsed or refractory mantle cell lymphoma (MCL).
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your health status, including blood tests and imaging to measure any lymph nodes or masses.
Your life expectancy should be at least 24 weeks, and you should have adequate blood, kidney, and liver function unless affected by the disease.
Step 3
Treatment cycle 1
You will receive three medications: rituximab, polatuzumab vedotin, and bendamustine hydrochloride. These are administered through an intravenous infusion, which means they are given directly into your vein.
The specific dosage and frequency will be determined by the medical team based on your individual needs.
Step 4
Interim assessment
After completing the initial treatment cycles, an interim assessment will be conducted to evaluate your response to the treatment.
This assessment will involve similar tests to the initial assessment, including imaging and blood tests.
Step 5
Treatment cycle 2-6
If the interim assessment shows a positive response, you will continue with additional treatment cycles up to a total of six cycles.
The same medications will be administered as in the first cycle, with adjustments made as necessary based on your response and any side effects experienced.
Step 6
Final assessment
A final assessment will be conducted after completing all treatment cycles to determine the overall effectiveness of the treatment.
This will include a comprehensive evaluation of your health status and any changes in the size of lymph nodes or masses.
Step 7
Follow-up
Regular follow-up visits will be scheduled to monitor your health and any long-term effects of the treatment.
These visits will help ensure any issues are addressed promptly and to gather data on the treatment's long-term efficacy.

Who can join the trial?

9 criteria

Ability to understand the purpose of the study and have given written informed consent.
Age must be 18 years or older.
Must have a confirmed diagnosis of relapsed or refractory Mantle Cell Lymphoma (MCL). This means the disease has returned or did not respond to previous treatment.
Must have received at least one prior treatment regimen, including a drug called ibrutinib.
If the participant has received a drug called bendamustine before, the response to it must have lasted more than 1 year.
Must have at least one lymph node or mass that can be measured to see how the disease responds to treatment.
Must have a life expectancy of at least 24 weeks.
Must have an ECOG performance status of 0 to 2. This is a scale used to assess how a disease affects a patient's daily living abilities, where 0 means fully active and 2 means capable of all self-care but unable to carry out any work activities.
Must have adequate blood, kidney, and liver function, unless any inadequate function is due to the underlying disease.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer besides Mantle cell lymphoma cannot participate.
Patients who have not reached the age of 18 cannot participate.
Patients who are unable to understand or follow the study procedures cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients with severe uncontrolled medical conditions cannot participate. This means if you have a serious health issue that is not being managed well, you cannot join the study.
Patients who have had a major surgery within the last 4 weeks cannot participate.
Patients with known allergies to the study medication cannot participate.
Patients who are currently using other investigational drugs cannot participate.
Patients with a history of drug or alcohol abuse within the last 12 months cannot participate.

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Verified sites

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Medical University Of Vienna
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Vienna, Austria

Trial locations

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Investigated drugs

Polatuzumab
is a type of medication known as an antibody-drug conjugate. It is designed to target and attach to specific cancer cells, delivering a powerful drug directly to them. This helps to kill the cancer cells while minimizing damage to healthy cells. In this trial, Polatuzumab is being used to treat patients with a type of cancer called mantle cell lymphoma that has returned or not responded to previous treatments.
Bendamustine
is a chemotherapy drug that works by interfering with the DNA inside cancer cells, preventing them from growing and multiplying. It is used in this trial to help control the spread of mantle cell lymphoma by killing cancer cells or stopping their growth.
Rituximab
is a medication that belongs to a class of drugs called monoclonal antibodies. It works by targeting a specific protein found on the surface of certain cancer cells, marking them for destruction by the body's immune system. In this trial, Rituximab is used to help the immune system find and destroy the cancer cells in patients with mantle cell lymphoma.

What is already known about the treatment

Polatuzumab
Polatuzumab is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its effectiveness in treating mantle cell lymphoma, a type of cancer. The medication works by targeting and binding to specific proteins on the surface of cancer cells, which helps the immune system to recognize and destroy these cells. Polatuzumab is classified as a monoclonal antibody, a type of drug designed to target specific cells in the body.
Bendamustine
Bendamustine is given as an intravenous infusion, which involves delivering the medication directly into the bloodstream through a vein. It is used in clinical trials to treat mantle cell lymphoma, particularly in cases where the disease has returned or is resistant to other treatments. Bendamustine works by damaging the DNA in cancer cells, preventing them from dividing and growing. It is classified as an alkylating agent, a type of chemotherapy drug that interferes with the DNA of cancer cells.
Rituximab
Rituximab is administered through an intravenous infusion, allowing the medication to enter the bloodstream directly. It is being tested in clinical trials for its role in treating mantle cell lymphoma, especially in patients whose cancer has relapsed or is difficult to treat. Rituximab targets a specific protein found on the surface of certain cancer cells, marking them for destruction by the immune system. It is classified as a monoclonal antibody, which is a type of targeted therapy designed to attack specific cells.

Investigated diseases

Mantle cell lymphoma – Mantle cell lymphoma is a type of non-Hodgkin lymphoma, which is a cancer that originates in the lymphatic system. It specifically affects B-cells, a type of white blood cell that plays a crucial role in the immune response. The disease is characterized by the abnormal growth of these B-cells, which can accumulate in lymph nodes, the spleen, bone marrow, and other organs. As the disease progresses, it can lead to symptoms such as swollen lymph nodes, fatigue, fever, night sweats, and weight loss. The progression of mantle cell lymphoma can vary, with some cases advancing slowly while others may progress more rapidly. The disease is considered rare and can be challenging to manage due to its complex nature.