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Study of Ibrutinib and Rituximab for Patients with Relapsed or Refractory 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 designed to explore the effectiveness of different treatment combinations for patients whose cancer has returned or has not responded to previous treatments. The treatments being studied include Ibrutinib combined with Rituximab, and a choice between Lenalidomide plus Rituximab or Bortezomib plus Rituximab. Ibrutinib and Lenalidomide are medications that help to stop the growth of cancer cells, while Rituximab is a type of antibody therapy that targets specific cancer cells. Bortezomib is a medication that interferes with the growth of cancer cells and is given by injection.

The purpose of this study is to provide continued access to these treatments for participants who benefit from them. Participants will be randomly assigned to one of the treatment groups and will receive the medications either as capsules taken by mouth or as injections. The study will monitor the participants' response to the treatment over a period of time to determine which combination is most effective in managing the disease.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to assess the effectiveness of the treatments. The study aims to find the best treatment option for patients with relapsed or refractory Mantle Cell Lymphoma, providing valuable information that could improve future treatment strategies for this condition.

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 participant is confirmed to have relapsed or refractory mantle cell lymphoma.
Eligibility is based on previous treatments and current health status, including organ function and disease progression.
Step 2
Treatment assignment
Participants are randomly assigned to one of the treatment groups.
The treatments include ibrutinib with rituximab, or a physician's choice of lenalidomide plus rituximab or bortezomib plus rituximab.
Step 3
Medication administration
Ibrutinib is taken orally in the form of 140 mg hard capsules.
Lenalidomide is available in various dosages (2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg) as hard capsules for oral use.
Bortezomib is administered as a 3.5 mg solution for injection.
Rituximab is given as a 500 mg concentrate for solution for infusion.
Step 4
Treatment duration
The study continues until the estimated end date of January 15, 2025.
Participants receive treatment as long as they continue to benefit from it.
Step 5
Monitoring and follow-up
Participants are regularly monitored for treatment effectiveness and any side effects.
Regular assessments ensure the participant's health and response to the treatment.

Who can join the trial?

13 criteria

Adult patients with confirmed Mantle Cell Lymphoma (MCL), a type of cancer.
Must have had at least one previous treatment for MCL, but not with a type of drug called BTKi.
Must have documented disease progression or relapse after the last treatment for MCL.
Must have measurable nodal disease, meaning the cancer can be measured in the lymph nodes.
Must have an ECOG score of 0 or 1, which indicates the patient is fully active or has some symptoms but can still do light work.
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Must have adequate organ function, which includes:
- ANC (a type of white blood cell) of at least 1000 per mm³
- Platelets of at least 50,000 cells per mm³
- Hemoglobin of at least 8 g/dL
- ALT/AST (liver enzymes) no more than 3 times the upper limit of normal
- Total bilirubin no more than 1.5 times the upper limit of normal
- CrCl (a measure of kidney function) of at least 30 mL/min
- Must not have been diagnosed or treated for any other cancer besides MCL, with some exceptions.
- Females of childbearing potential and male participants with partners who can become pregnant must follow a strict pregnancy prevention plan.

Who cannot join the trial?

8 criteria

Patients who do not have Relapsed/Refractory Mantle Cell Lymphoma cannot participate. This means the study is only for those whose specific type of cancer has returned or did not respond to previous treatment.
Patients who are not within the specified age range cannot participate. The study is for adults only.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are participating in another clinical trial cannot participate.
Patients who have had a recent major surgery or are planning to have surgery during the study cannot participate.
Patients who have a known allergy to the study medication or its ingredients cannot participate.

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Verified sites

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

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Hospital Universitario De Salamanca
Salamanca, Spain
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Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Warsaw, Poland
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Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie
Lublin, Poland

Trial locations

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Investigated drugs

Ibrutinib
is a medication used in this trial to treat mantle cell lymphoma, a type of cancer. It works by blocking a specific protein that helps cancer cells grow and survive, thereby slowing down or stopping the progression of the disease.
Rituximab
is an antibody therapy used in combination with other medications in this trial. It targets and attaches to a specific protein found on the surface of cancer cells, helping the immune system to destroy these cells.
Lenalidomide
is a medication that helps the immune system fight cancer. It works by affecting the immune system and directly attacking cancer cells, which can help to slow down or stop the growth of cancer.
Bortezomib
is a medication that interferes with the growth of cancer cells. It works by blocking the action of proteasomes, which are structures inside cells that break down proteins. By inhibiting these structures, bortezomib can cause cancer cells to die.

What is already known about the treatment

Ibrutinib
Ibrutinib is administered orally in the form of capsules or tablets. It is currently approved for use in certain types of blood cancers and is well-documented in medical literature. The main therapeutic indication for Ibrutinib is the treatment of relapsed or refractory mantle cell lymphoma. It works by inhibiting a protein called Bruton's tyrosine kinase, which is involved in the growth and survival of cancer cells. Ibrutinib is classified as a targeted therapy, specifically a kinase inhibitor.
Rituximab
Rituximab is administered via intravenous infusion. It is widely used and well-established in medical literature for treating various types of blood cancers and autoimmune diseases. The primary therapeutic indication for Rituximab in this context is relapsed or refractory mantle cell lymphoma. It functions by targeting the CD20 protein on the surface of B-cells, leading to their destruction. Rituximab is classified as a monoclonal antibody.
Lenalidomide
Lenalidomide is taken orally in capsule form. It is an approved medication with extensive documentation in medical literature, primarily used for certain blood cancers. In this trial, its main therapeutic indication is relapsed or refractory mantle cell lymphoma. Lenalidomide works by modulating the immune system and inhibiting the growth of cancer cells. It is classified as an immunomodulatory agent.
Bortezomib
Bortezomib is administered either intravenously or subcutaneously. It is a well-established medication in medical literature, used mainly for treating multiple myeloma and certain lymphomas. In this trial, it is indicated for relapsed or refractory mantle cell lymphoma. Bortezomib acts by inhibiting proteasomes, which are enzyme complexes that break down proteins in cells, leading to cancer cell death. It is classified as a proteasome 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 spread to other tissues such as the bone marrow, spleen, and gastrointestinal tract. The disease is characterized by the overproduction of abnormal B-cells, which can lead to swollen lymph nodes, fatigue, and weight loss. As it progresses, it may cause symptoms related to the affected organs, such as abdominal pain or discomfort. The relapsed or refractory form of this lymphoma indicates that the disease has returned after treatment or is resistant to standard therapies.