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Study Comparing Rituximab with Ibrutinib to Rituximab with Chemotherapy for Older Patients with Untreated 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 a type of cancer called Mantle Cell Lymphoma (MCL), which is a rare form of non-Hodgkin's lymphoma. The study aims to compare two different treatment approaches for older patients who have not yet received treatment for MCL. One group of patients will receive a combination of Rituximab and Ibrutinib, while the other group will receive Rituximab along with various chemotherapy drugs. The chemotherapy drugs being studied include Prednisolone, Cyclophosphamide, Vincristine Sulfate, Bendamustine Hydrochloride, and Doxorubicin Hydrochloride. The purpose of the study is to determine which treatment is more effective in preventing the cancer from getting worse.

Participants in the study will be randomly assigned to one of the two treatment groups. The study will be conducted over a period of time, with regular check-ups and assessments to monitor the progress of the disease and the patient's response to the treatment. The main focus will be on how long patients can live without the disease getting worse, which is known as progression-free survival. Other aspects such as overall survival, disease response, safety, and quality of life will also be evaluated.

This study is designed to provide valuable information on the best treatment options for older patients with untreated Mantle Cell Lymphoma. By comparing the effectiveness of Rituximab with Ibrutinib against Rituximab with chemotherapy, researchers hope to find a treatment that offers better outcomes for patients. The study will continue until the end of 2026, with the goal of improving the understanding and management of this challenging disease.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, kidney function, and cardiac health.
Consent is required to participate, and the condition of mantle cell lymphoma (MCL) must be confirmed.
Step 2
Randomization
Participants are randomly assigned to one of two treatment groups: Rituximab/Ibrutinib or Rituximab/Chemotherapy.
Step 3
Treatment phase
For those in the Rituximab/Ibrutinib group, Ibrutinib is administered orally in the form of 140 mg hard capsules.
For those in the Rituximab/Chemotherapy group, treatment includes a combination of drugs administered intravenously: Prednisolone, Cyclophosphamide, Vincristine Sulfate, Bendamustine Hydrochloride, and Doxorubicin Hydrochloride.
Step 4
Monitoring and assessments
Progression-free survival is monitored, which is the time from randomization until disease progression or death.
Overall survival is tracked from randomization until death from any cause.
Disease response is assessed using CT scans and bone marrow biopsies, following standardized criteria.
Safety and side effects are evaluated based on adverse events.
Quality of life is measured using a specific questionnaire.
Step 5
End of study
The study is estimated to conclude by December 31, 2026.
The time to the next MCL treatment is recorded, which is the period from randomization to the start of the next treatment or death.

Who can join the trial?

12 criteria

Patients must be male or female and **60 years or older**.
Must have a **calculated creatinine clearance** greater than 30 mL/min. This is a measure of kidney function.
Heart function must be good enough to handle certain chemotherapy treatments, specifically Rituximab-CHOP or Rituximab-Bendamustine.
Must be able to provide **voluntary written informed consent**, meaning they understand the study and agree to participate.
Must have a confirmed diagnosis of **Mantle Cell Lymphoma (MCL)**, with specific characteristics in the cancer cells.
The disease must be at **Stage II-IV**, which means it is more advanced, and it must be measurable by imaging tests, with a size greater than 1.5 cm.
Should not have received previous treatment for MCL, except for localized radiotherapy or a short course of steroids for symptom relief.
Must be willing and able to take medication to prevent a specific type of pneumonia called **Pneumocystis jiroveci Pneumonia**.
Must have a **performance status** of ECOG 0-2, which is a scale that measures how well a patient can perform daily activities.
Must have an **absolute neutrophil count** greater than 1.0x10^9/L and **platelets** greater than 100x10^9/L, which are measures of certain blood cells.
**AST and/or ALT** levels must be less than 3 times the upper limit of normal (ULN). These are liver enzymes.
**Total bilirubin** must be 1.5 times the ULN or less, unless the increase is due to a condition called **Gilbert’s syndrome** or another non-liver-related cause.

Who cannot join the trial?

3 criteria

Patients who do not have Mantle Cell Lymphoma (MCL) cannot participate. MCL is a type of cancer that affects the lymph nodes.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

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Verified sites

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Responsive
Region Midtjylland
Aarhus, Denmark
Responsive
Region Oestergoetland
Linkoping, Sweden
Responsive
Region Vaesterbotten
Umea, Sweden

Trial locations

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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.
Ibrutinib
is a medication that helps to stop the growth and spread of cancer cells. It is used in the treatment of mantle cell lymphoma by blocking certain enzymes that cancer cells need to grow.
Chemotherapy
refers to a group of cancer treatments that use powerful drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is used in combination with other medications to treat mantle cell lymphoma.

What is already known about the treatment

Rituximab
Rituximab is administered through an intravenous infusion, typically in a clinical setting. It is widely used in medicine, particularly for treating certain types of blood cancers and autoimmune diseases. The main therapeutic indication for Rituximab in this trial is Mantle Cell Lymphoma (MCL). It works by targeting a specific protein called CD20 found on the surface of B-cells, leading to the destruction of these cells. Rituximab is classified as a monoclonal antibody.
Ibrutinib
Ibrutinib is taken orally in the form of a capsule. It is an established medication in the treatment of various blood cancers, including Mantle Cell Lymphoma (MCL). The drug functions by inhibiting a protein called Bruton's tyrosine kinase (BTK), which is crucial for the survival and proliferation of cancerous B-cells. Ibrutinib is classified as a targeted therapy, specifically a BTK inhibitor.

Investigated diseases

Mantle Cell Lymphoma – Mantle Cell Lymphoma (MCL) is a type of non-Hodgkin's 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. MCL is characterized by the abnormal growth of these B-cells, which can lead to the formation of tumors in lymph nodes and other tissues. The disease often progresses by spreading to other parts of the body, including the bone marrow and gastrointestinal tract. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of MCL can vary, with some cases advancing more rapidly than others.