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Study on Axicabtagene Ciloleucel for Patients with Late Relapse of Diffuse Large B-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 Diffuse Large B-Cell Lymphoma (DLBCL), which is a form of non-Hodgkin lymphoma. The study is investigating the effectiveness of a treatment called Axicabtagene Ciloleucel, which is a type of cell therapy. This treatment involves using a patient's own immune cells, known as T cells, which are modified to better fight cancer. The trial aims to see how well this treatment works for patients who have experienced a late relapse of DLBCL, meaning their cancer returned between one and five years after their initial treatment.

Participants in the study will receive Axicabtagene Ciloleucel through an intravenous infusion, which means the treatment is given directly into the bloodstream. Before receiving this treatment, patients may also receive other medications, such as Cyclophosphamide and Fludarabine, which are used to prepare the body for the cell therapy. These medications help to create a more favorable environment for the modified T cells to work effectively. The study will monitor patients over time to assess their response to the treatment, including whether the cancer shows signs of improvement or remission.

The purpose of this study is to evaluate the effectiveness of Axicabtagene Ciloleucel in treating patients with DLBCL who have relapsed after their initial therapy. The trial will track various outcomes, such as the overall response rate, which measures how many patients experience a reduction in cancer symptoms, and the duration of response, which looks at how long the treatment remains effective. Additionally, the study will observe any side effects or adverse events that may occur during and after the treatment. The trial is expected to continue until 2031, providing valuable insights into the potential benefits and risks of this innovative therapy for DLBCL patients.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.
A series of tests, including blood tests and imaging scans, are performed to establish a baseline for the study.
Step 2
Leukapheresis procedure
A procedure called leukapheresis is performed to collect white blood cells. This is necessary for the preparation of the personalized treatment.
The procedure involves drawing blood, separating the white blood cells, and returning the remaining blood components to the body.
Step 3
Pre-treatment with chemotherapy
Before receiving the main treatment, a short course of chemotherapy is administered. This includes cyclophosphamide and fludarabine, given as intravenous infusions.
The chemotherapy helps to prepare the body for the main treatment by reducing the number of existing immune cells.
Step 4
Axicabtagene ciloleucel infusion
The main treatment involves an infusion of axicabtagene ciloleucel, a type of therapy designed to target and destroy cancer cells.
This is administered as a single intravenous infusion.
Step 5
Monitoring and follow-up
After the infusion, regular monitoring is conducted to assess the response to treatment and manage any side effects.
Follow-up visits include imaging scans and blood tests to evaluate the effectiveness of the treatment.
Step 6
Supportive care
Supportive care, including the administration of tocilizumab if necessary, is provided to manage potential side effects such as inflammation.
This care is tailored to individual needs and may involve additional medications or therapies.
Step 7
Long-term follow-up
Long-term follow-up continues for up to five years to monitor overall health and any late effects of the treatment.
This includes periodic assessments of quality of life and any ongoing health concerns.

Who can join the trial?

17 criteria

Must sign a written form agreeing to participate in the study.
Must be older than 18 years.
Must understand and speak one of the official languages of the country.
Must have a confirmed diagnosis of a type of aggressive B-cell non-Hodgkin lymphoma, which includes diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), or follicular lymphoma Grade 3B. If the lymphoma has changed from a slow-growing type to an aggressive type and was treated with a specific chemotherapy regimen called R-CHOP-like, the patient is eligible. However, primary mediastinal B-cell lymphoma is not eligible.
Must have a positive result on a special imaging test called positron-emission tomography (PET).
Must have received a specific first-line treatment that includes an anti-CD20 monoclonal antibody (like rituximab or obinutuzumab) and a chemotherapy regimen called CHOP or similar. Some variations of CHOP are allowed, but not if the dose was reduced, except for a specific drug due to nerve issues.
Must have experienced a return of the disease after the first treatment, confirmed by a PET scan and a biopsy. The disease must have returned between 12 months and 5 years after the end of the first treatment.
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Must meet certain criteria to be eligible for CAR T-cell therapy, which includes:
- Being approved for CAR T-cell therapy by a specialist.
- Having a performance status score of 0, 1, or 2, which measures the ability to perform daily activities.
- Having suitable blood vessel access for a procedure called leukapheresis.
- Having a certain level of white blood cells, platelets, and lymphocytes.
- Having a certain level of kidney function, measured by creatinine clearance.
- Having liver enzyme levels within a specific range.
- Having a certain level of total bilirubin, unless the patient has a condition called Gilbert's syndrome.
- Having a heart function measurement called cardiac ejection fraction of at least 45%.
- Having a baseline oxygen level of at least 92% when breathing room air.
- Females who can have children must have a negative pregnancy test. Females who have had surgery to prevent pregnancy or have not had a menstrual period for at least 12 months are not considered able to have children.

Who cannot join the trial?

4 criteria

Patients who have not experienced a **late relapse** of their condition. A late relapse means the return of the disease between 1 and 5 years after finishing the first treatment.
Patients who have not been diagnosed with **Diffuse Large B-Cell Lymphoma**. This is a type of cancer that affects the white blood cells.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means groups that might need special protection or care.

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Verified sites

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

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El Hospital Universitario De Gran Canaria Dr. Negrin
Las Palmas De Gran Canaria, Spain
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Hospital Clinic De Barcelona
Barcelona, Spain
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Hospital General Universitario Gregorio Maranon
Madrid, Spain

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Investigated drugs

Axicabtagene Ciloleucel is a type of therapy used in this clinical trial. It is a form of treatment known as CAR T-cell therapy, which involves modifying a patient's own immune cells to better recognize and attack cancer cells. This therapy is being tested for its effectiveness in patients who have experienced a late relapse of diffuse large B-cell lymphoma, a type of blood cancer, after their initial treatment. The goal is to see if this therapy can help achieve a complete metabolic response, meaning the cancer is no longer detectable using certain imaging tests.

What is already known about the treatment

Axicabtagene Ciloleucel – This medication is administered through an intravenous infusion, typically in a hospital setting. It is currently being studied in clinical trials for its effectiveness in treating patients with late relapse of Diffuse Large B-Cell Lymphoma (DLBCL). The main therapeutic indication is for patients who have relapsed between one and five years after initial treatment. At the molecular level, axicabtagene ciloleucel works by modifying a patient's own T-cells to recognize and attack cancer cells. It is classified as a CAR T-cell therapy, which is a type of immunotherapy designed to enhance the body's natural defenses against cancer.

Investigated diseases

Diffuse Large B-Cell Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell responsible for producing antibodies. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. The disease can start in any part of the body and may spread to other areas, including the bone marrow and central nervous system. Symptoms often include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing quickly while others may develop more slowly. It is the most common type of non-Hodgkin lymphoma in adults.