RecruitingRare disease

Study on CAR-T-cell Therapy with Rituximab and Ibrutinib for Patients with High-Risk 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 explore the effectiveness of a treatment strategy using a special type of therapy known as CAR-T-cell treatment with a medication called KTE-X19. This treatment involves using the patient's own immune cells, which are modified to better fight cancer cells. The trial will compare this approach to the standard treatment methods currently used for patients with high-risk MCL.

Participants in the study will be divided into two groups. One group will receive the experimental treatment, which includes a combination of Rituximab and Ibrutinib followed by the CAR-T-cell therapy. The other group will receive the standard treatment, which is the usual care provided for MCL. The study will also involve the use of several other medications, including Thiotepa, Cisplatin, Etoposide, Melphalan, Cytarabine, Cyclophosphamide, Doxorubicin, Filgrastim, Oxaliplatin, Prednisolone, Bendamustine, Carmustine, Pegfilgrastim, Fludarabine, Vincristine Sulfate, Rituximab, Dexamethasone, and Tocilizumab, which are used to support the treatment process.

The purpose of the study is to compare the effectiveness of the CAR-T-cell treatment strategy with the standard treatment in patients who have not been treated for MCL before. Participants will undergo a series of treatments and follow-ups over a period of time to monitor their response to the therapy. The study will help determine if the new treatment approach can improve outcomes for patients with high-risk MCL compared to the current standard of care.

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 is assigned to one of two treatment groups: experimental treatment (Arm A) or standard care (Arm B).
The study focuses on patients with high-risk mantle cell lymphoma (MCL).
Step 2
Induction therapy
In Arm A, the patient receives an abbreviated induction therapy with rituximab and ibrutinib. Rituximab is administered through an intravenous infusion, while ibrutinib is taken orally in the form of 140 mg hard capsules.
In Arm B, the patient undergoes standard induction therapy, which may include a combination of medications such as cyclophosphamide, doxorubicin, vincristine sulfate, and prednisolone, all administered through intravenous infusion or oral routes as specified by the healthcare provider.
Step 3
CAR-T-cell treatment
Patients in Arm A receive CAR-T-cell treatment with brexucabtagene autoleucel (Tecartus), administered as an intravenous infusion.
This step involves the collection and modification of the patient's T-cells to target cancer cells more effectively.
Step 4
Maintenance therapy
In Arm A, the patient continues with ibrutinib maintenance therapy for 6 months, taking the medication orally.
In Arm B, the patient follows the standard maintenance therapy as determined by the healthcare provider, which may include medications like rituximab and others as needed.
Step 5
Monitoring and follow-up
Throughout the trial, the patient's health and response to treatment are closely monitored through regular check-ups and tests.
The primary goal is to assess failure-free survival, progression-free survival, and overall response rates, among other outcomes.

Who can join the trial?

19 criteria

Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL) according to the World Health Organization classification, with specific markers like overexpression of cyclin D1 or presence of a genetic change called t(11;14).
Age between 18 and 75 years.
Must have at least one measurable tumor or lesion, as defined by specific medical criteria. If the cancer is only in the bone marrow, a bone marrow test is required.
Must have an ECOG performance status of 2 or less, which means the patient is able to carry out all self-care but unable to carry out any work activities.
Must have certain laboratory test results within specific ranges, unless the results are affected by MCL:
- White blood cells called neutrophils must be at least 1000 cells per microliter.
- Platelets, which help with blood clotting, must be at least 75,000 cells per microliter.
- Creatinine, a waste product in the blood, must be less than 2 mg/dL, or the kidney function test called creatinine clearance must be at least 60 mL/min.
- Transaminases (AST and ALT), which are liver enzymes, must be less than 2.5 times the upper limit of normal.
- Total bilirubin, a substance made during the breakdown of red blood cells, must be less than or equal to 2 times the upper limit of normal, unless there is another known reason.
- No evidence of disease in the central nervous system (CNS).
- Available only in France.
- Must provide written informed consent and be able to follow study instructions and attend all required visits.
- Sexually active men and women who can have children must agree to use highly effective birth control methods during the study and for a period after the study ends.
- Women who can have children must have a negative pregnancy test. Women who have been surgically sterilized or are postmenopausal for at least 2 years are not considered to be of childbearing potential.
- Must agree not to drive a motor vehicle for 8 weeks after receiving CAR T cell treatment.
- Must be able to reach the study site within 2 hours in case of an emergency.
- Must have at least one high-risk feature of MCL, such as a high score on a specific risk index (MIPI-c) or a genetic mutation called TP53.
- No prior treatment for MCL.
- Cancer must be at stage II-IV according to the Ann Arbor staging system.

Who cannot join the trial?

5 criteria

Patients who have already received treatment for Mantle Cell Lymphoma (MCL) cannot participate. Mantle Cell Lymphoma is a type of cancer that affects the lymph nodes.
Patients who are not considered high risk for Mantle Cell Lymphoma are excluded. High risk means the disease is more likely to progress quickly or be more severe.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population may not be eligible. Vulnerable population refers to groups who may have additional risks or challenges, such as children, pregnant women, or those with certain disabilities.
Patients who do not meet other specific health criteria set by the study may be excluded. These criteria ensure the safety and appropriateness of the study for participants.

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Verified sites

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

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Verified
Mainz, Germany
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands

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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. In this trial, Rituximab is used as part of an initial treatment to help reduce the number of cancer cells.
Ibrutinib
is a medication that helps to slow down or stop the growth of cancer cells. It is used in this trial to treat mantle cell lymphoma by interfering with the pathways that cancer cells use to grow and survive. Ibrutinib is given both during the initial treatment phase and as a maintenance therapy to help keep the cancer from returning.
KTE-X19
is a type of CAR-T-cell therapy used in this trial. CAR-T-cell therapy involves modifying a patient's own immune cells to better recognize and attack cancer cells. KTE-X19 is specifically designed to target mantle cell lymphoma cells, offering a personalized approach to treatment. This therapy is used after the initial treatment phase to intensify the treatment and improve outcomes for patients with high-risk mantle cell lymphoma.

What is already known about the treatment

Rituximab
Rituximab is administered intravenously and is used in the treatment of various types of lymphoma, including Mantle Cell Lymphoma (MCL). It is a well-established medication in medical literature and is commonly used in combination with other therapies. Rituximab works by targeting a specific protein on the surface of B-cells, leading to their destruction. It is classified as a monoclonal antibody.
Ibrutinib
Ibrutinib is taken orally and is used to treat Mantle Cell Lymphoma (MCL) among other conditions. It is widely recognized in medical literature and is often used in combination with other treatments. Ibrutinib functions by inhibiting a protein called Bruton's tyrosine kinase, which is involved in the growth and survival of cancer cells. It belongs to the class of medications known as kinase inhibitors.
KTE-X19
KTE-X19 is administered through an infusion and is currently being explored in clinical trials for its effectiveness in treating Mantle Cell Lymphoma (MCL). It is a type of CAR-T-cell therapy, which is a newer approach in cancer treatment. KTE-X19 works by modifying a patient's own T-cells to better recognize and attack cancer cells. It is part of the immunotherapy class of treatments.

Investigated diseases

Mantle Cell Lymphoma – Mantle Cell Lymphoma (MCL) 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 outer edge of a lymph node called the mantle zone. The disease often progresses to involve other lymph nodes, bone marrow, and sometimes the spleen and gastrointestinal tract. MCL is characterized by the overproduction of abnormal B-cells, which can lead to the enlargement of lymph nodes and other organs. As the disease advances, it can cause symptoms such as fatigue, fever, night sweats, and weight loss. The progression of MCL can vary, with some cases advancing more rapidly than others.