Not recruiting

Study on Rituximab, Bendamustine, Cytarabine, and Venetoclax for High-Risk Elderly Patients with Mantle Cell Lymphoma

Fast replyRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 (MCL), which is a rare form of non-Hodgkin's lymphoma. The study is specifically for high-risk elderly patients who have not received treatment before. The treatment being tested involves a combination of medications: Rituximab, Bendamustine, and Cytarabine, followed by Venetoclax. Rituximab is a monoclonal antibody, Bendamustine is an alkylating agent, Cytarabine is a pyrimidine analogue, and Venetoclax is a BCL2 inhibitor. These medications are used to target and kill cancer cells in different ways.

The purpose of the study is to see if adding Venetoclax after the initial treatment with Rituximab, Bendamustine, and Cytarabine can improve the outcomes for patients. The study will follow participants over a period to monitor their response to the treatment. Initially, patients will receive Rituximab, Bendamustine, and Cytarabine through intravenous infusions, which means the medication is given directly into a vein. After this phase, Venetoclax will be taken orally, which means it is swallowed in pill form. The study aims to determine if this combination can help patients live longer without the disease getting worse.

Throughout the study, researchers will observe how well the treatment works and how safe it is for the participants. They will look at how long patients remain free from disease progression, the overall survival rates, and any side effects that may occur. The study will also assess the proportion of patients who achieve complete remission, which means the disappearance of all signs of cancer in response to treatment. This trial is an important step in finding more effective treatments for high-risk elderly patients with Mantle Cell Lymphoma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The treatment begins with the administration of rituximab, bendamustine, and cytarabine. These medications are given through a vein, a method known as intravenous administration.
This phase is designed to target and reduce the lymphoma cells in the body. The specific schedule and dosage will be determined by the healthcare provider based on individual health conditions and response to treatment.
Step 2
Venetoclax administration
Following the initial treatment phase, venetoclax is introduced. This medication is taken orally, meaning it is swallowed in the form of a pill.
The purpose of venetoclax is to further improve treatment outcomes by targeting specific cancer cells. The dosage and duration will be tailored to the patient's needs and monitored by the healthcare team.
Step 3
Monitoring and follow-up
Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes blood tests, imaging studies, and other necessary evaluations.
The healthcare team will provide guidance on managing any side effects and will adjust the treatment plan as needed to ensure the best possible outcomes.
Step 4
Completion and evaluation
Upon completion of the treatment schedule, a comprehensive evaluation is performed to determine the overall response to the therapy.
This includes assessing the progression-free survival, which measures the length of time during and after treatment that the patient lives with the disease without it getting worse.

Who can join the trial?

9 criteria

Patients who have not been treated before for **Mantle Cell Lymphoma (MCL)** and are **65 years or older**, if they are considered **FIT** based on a special health assessment for older adults.
Patients **64 years or younger** who are not suitable for high-dose chemotherapy and transplantation, as decided by their doctor. This decision is based on a health rating scale called the **Cumulative Illness Rating Scale (CIRS)**.
Patients must have a **measurable disease** with a size of at least **1.5 cm** in the longest direction and measurable in two directions.
Patients must have an **ECOG performance status** of **2 or less**. This is a scale that measures how well a patient can perform daily activities.
Patients must test positive for **cyclin D1** and/or **SOX11**. If cyclin D1 is negative, SOX11 must be positive.
Patients must have **adequate kidney function**, with a creatinine clearance greater than **50 mL/min** and normal urine output.
Patients must have **adequate liver function**, with specific liver enzyme levels and bilirubin within acceptable limits, unless these are affected by the tumor or inherited conditions.
Patients who have a positive test for **Hepatitis B core antibody (HBcAb)** but are negative for other hepatitis B markers can join if they receive proper antiviral treatment at least two weeks before starting the study treatment.
Patients must provide **written informed consent**, which means they agree to participate in the study after understanding all the details.

Who cannot join the trial?

6 criteria

Patients with other types of cancer besides Mantle Cell Lymphoma cannot participate. Mantle Cell Lymphoma is a type of cancer that affects the lymph nodes.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are not considered high-risk (HR) for Mantle Cell Lymphoma cannot participate. High-risk patients are those who have a greater chance of the disease progressing or returning.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups who may have difficulty giving informed consent or are at higher risk of harm.
Patients who have not received the standard treatment known as R-BAC cannot participate. R-BAC is a combination of drugs used to treat Mantle Cell Lymphoma.
Patients who are unable to take the additional drug called venetoclax cannot participate. Venetoclax is a medication that helps to kill cancer cells.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Responsive
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Di Sassari
Sassari, Italy

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Rituximab
is a medication used to treat certain types of cancer, including mantle cell lymphoma. It works by targeting specific proteins on the surface of cancer cells, helping the immune system to destroy them.
Bendamustine
is a chemotherapy drug that is used to treat cancer by damaging the DNA of cancer cells, which prevents them from dividing and growing.
Cytarabine
is another chemotherapy medication that interferes with the DNA of cancer cells, stopping them from multiplying and spreading.
Venetoclax
is a medication that helps to kill cancer cells by blocking a protein that allows them to survive. It is used in this trial to see if it can improve the effectiveness of the standard treatment for mantle cell lymphoma.

What is already known about the treatment

Rituximab
This medication is administered intravenously and is used in combination with other drugs for treating certain types of cancer, including mantle cell lymphoma. It is well-established in medical literature and is commonly used in clinical practice. Rituximab works by targeting a specific protein on the surface of cancer cells, leading to their destruction. It is classified as a monoclonal antibody.
Bendamustine
Administered intravenously, bendamustine is used to treat mantle cell lymphoma among other cancers. It is recognized in medical literature and is part of standard treatment regimens. Bendamustine works by damaging the DNA in cancer cells, which prevents them from dividing and growing. It is classified as an alkylating agent.
Cytarabine
This medication is given by injection and is used in the treatment of various types of leukemia and lymphoma, including mantle cell lymphoma. It is well-documented in medical literature and widely used in clinical settings. Cytarabine interferes with the DNA synthesis of cancer cells, inhibiting their growth. It is classified as an antimetabolite.
Venetoclax
Administered orally, venetoclax is used in the treatment of certain blood cancers, including mantle cell lymphoma. It is a newer addition to medical literature and is being evaluated for its effectiveness in combination therapies. Venetoclax works by inhibiting a protein that helps cancer cells survive, leading to their death. It is classified as a BCL-2 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 lymph nodes but can also affect other areas such as the spleen, bone marrow, and digestive tract. The disease is characterized by the overproduction of abnormal B-cells, which can lead to the enlargement of lymph nodes and other organs. As the disease progresses, it may cause symptoms like 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.