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Study on the Effectiveness and Safety of Ibrutinib and Rituximab for Patients with Indolent 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, which is a rare form of non-Hodgkin's lymphoma. The study is testing a combination of two treatments: Ibrutinib and Rituximab. Ibrutinib is taken as a capsule, while Rituximab is given through an infusion into a vein. The purpose of the study is to evaluate how effective and safe this combination is for patients with a less aggressive form of Mantle Cell Lymphoma.

Participants in the study will receive the combination of Ibrutinib and Rituximab over a period of time. The study will monitor the participants to see how well the treatment works and to check for any side effects. The goal is to see if this combination can be a good alternative to the usual treatment, which is a type of chemotherapy known as the R-CHOP regimen. The study will look at how many patients have a complete response to the treatment after 12 months.

Throughout the study, researchers will also gather information on the overall response rate, how long patients stay free from disease progression, and the duration of the response to the treatment. They will also assess the quality of life of the participants during the treatment. Additionally, the study will include genomic studies to better understand the disease and the effects of the treatment. The study is expected to continue until the end of 2029.

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, the patient will have a confirmed diagnosis of Mantle Cell Lymphoma. The patient must meet specific criteria, such as being asymptomatic and having stable disease without progression for at least 3 months.
The patient must be 18 years or older and have not received any prior therapies, except for diagnostic splenectomy. Women of childbearing potential must have a negative pregnancy test, and all participants must agree to use effective birth control methods during and after the study.
Step 2
Treatment initiation
The treatment involves a combination of two medications: ibrutinib and rituximab. Ibrutinib is administered orally in the form of 140 mg hard capsules, while rituximab is given intravenously as a solution for infusion.
The patient will receive these medications as part of the study to evaluate their effectiveness and safety in treating indolent forms of Mantle Cell Lymphoma.
Step 3
Treatment duration
The treatment will continue for a period of 12 months. During this time, the patient will be monitored to assess the rate of complete responses to the medication combination.
The primary goal is to achieve complete remission at the end of the 12-month treatment period.
Step 4
Monitoring and assessments
Throughout the study, the patient will undergo regular assessments to monitor the overall response rate, progression-free survival, and duration of response.
The study will also evaluate the health-related quality of life and conduct genomic studies to understand the molecular response in patients.
Step 5
End of treatment
At the end of the 12-month treatment period, the patient will have a final assessment to determine the overall effectiveness of the treatment.
The study aims to provide insights into the potential of ibrutinib and rituximab as a therapeutic alternative for patients with indolent Mantle Cell Lymphoma.

Who can join the trial?

13 criteria

Patients must have a confirmed diagnosis of Mantle Cell Lymphoma, which is a type of cancer affecting the lymph nodes. Different forms of this condition can be included.
The disease must be stable without getting worse for at least 3 months. Patients who have not been receiving treatment for a long time may also be included.
Women who can have children and men who are sexually active must use a very effective method of birth control during and after the study. Men must not donate sperm during and after the study. These rules apply for 1 month after the last dose for women and 3 months for men.
Women who can have children must have a negative pregnancy test before starting the study. Pregnant or breastfeeding women cannot participate.
Participants must sign a consent form to show they understand the study and agree to take part.
Participants must be 18 years or older.
Participants must not have received any previous treatments for their condition, except for a diagnostic procedure called splenectomy.
Participants should not have any symptoms.
The disease can be in any stage from I to IV, according to a system called the Ann Arbor staging system.
Participants must have a performance status of less than 2 on a scale used to measure daily living abilities, called the Eastern Cooperative Oncology Group (ECOG) performance status.
Participants with a type of MCL that mainly affects the bone marrow or blood can be included.
Other types of MCL with low tumor burden, such as those with lymph nodes not larger than 3 cm and low cell growth rate, can also be included.
Participants must have certain laboratory test results within specific ranges, such as a certain number of white blood cells, hemoglobin levels, and liver and kidney function tests.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer other than Mantle Cell Lymphoma cannot participate. Mantle Cell Lymphoma is a specific type of cancer that affects the lymph nodes.
Patients who are not within the specified age range for the study cannot participate. The study is looking for participants within certain age groups.
Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
Patients who are pregnant or breastfeeding cannot participate, as the study may involve treatments that could affect the baby.
Patients who have other serious health conditions that could interfere with the study treatment or outcomes cannot participate.
Patients who are currently participating in another clinical trial cannot join this study, as it could affect the results.
Patients who have had certain treatments for their cancer in the past that might interfere with the study cannot participate.
Patients who have allergies or reactions to the study medications cannot participate, as it could be unsafe for them.

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Verified sites

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

Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Costa del Sol
Verified
Marbella, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

Trial locations

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Investigated drugs

Ibrutinib
is a medication used in this trial to treat patients with a type of cancer called Mantle Cell Lymphoma. It works by blocking a specific protein that helps cancer cells grow and survive. By inhibiting this protein, Ibrutinib can help slow down or stop the growth of cancer cells.
Rituximab
is another medication used in combination with Ibrutinib in this trial. It is a type of therapy known as a monoclonal antibody. Rituximab targets a specific protein found on the surface of certain cancer cells, marking them for destruction by the body's immune system. This helps to reduce the number of cancer cells in the body.

What is already known about the treatment

Ibrutinib
Ibrutinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating Mantle Cell Lymphoma, particularly in combination with other medications. The main therapeutic indication for Ibrutinib is its use in certain types of blood cancers, including Mantle Cell Lymphoma. At the molecular level, Ibrutinib works by inhibiting a protein called Bruton's tyrosine kinase (BTK), which plays a crucial role in the survival and proliferation of cancer cells. It is classified as a targeted therapy, specifically a BTK inhibitor.
Rituximab
Rituximab is administered through intravenous infusion. It is widely used in medical practice and literature for treating various types of blood cancers and autoimmune diseases. The main therapeutic indication for Rituximab is its use in conditions like Mantle Cell Lymphoma and other lymphomas. Rituximab works by targeting a specific protein called CD20 found on the surface of certain immune cells, leading to their destruction. It is classified as a monoclonal antibody, which is a type of targeted therapy.

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 affects the lymph nodes but can also involve the spleen, bone marrow, and gastrointestinal tract. The disease is characterized by the overproduction of abnormal B-cells, leading to the enlargement of lymph nodes and other organs. It often progresses slowly, but in some cases, it can become more aggressive. Symptoms may include fatigue, fever, night sweats, and unexplained weight loss. The progression of the disease can vary, with some patients experiencing a more indolent course while others may have a more rapid progression.