Study of Ibrutinib and Rituximab for Patients with Relapsed or Refractory Mantle Cell Lymphoma

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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.
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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain

Other Sites

Site Name	City	Country
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza	Brzozow	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	31.10.2022
Poland	Not recruiting	31.10.2022
Spain	Not recruiting	31.10.2022

Trial locations

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.

Investigated diseases:

Mantle cell lymphoma

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.

Trial ID:

2023-503618-64-00

Protocol code:

54179060MCL3004

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Ibrutinib and Rituximab for Patients with Relapsed or Refractory Mantle Cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?