Not recruitingRare disease

Study of Axicabtagene Ciloleucel for Patients with Relapsed or Refractory Primary Mediastinal B-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 Primary Mediastinal Large B-Cell Lymphoma (PMBCL). This is a form of lymphoma, which is a cancer that starts in the cells of the immune system. The treatment being tested in this study is called Axicabtagene Ciloleucel, also known by its code name KTE-C19. This treatment is a type of cell therapy where a patient's own immune cells are modified to better fight the cancer.

The purpose of the study is to evaluate how effective Axicabtagene Ciloleucel is in treating patients with PMBCL that has either returned after treatment or has not responded to previous treatments. Participants in the study will receive the treatment through an infusion, which is a way of delivering medication directly into the bloodstream. The study will monitor the participants over a period to see how well the treatment works in reducing or eliminating the cancer.

Throughout the study, participants will undergo various assessments, including imaging tests like PET-CT or PET-MRI, to evaluate the response of the cancer to the treatment. These tests help doctors see how the cancer is reacting to the therapy. The study aims to gather information on the treatment's effectiveness and any potential side effects, contributing to the understanding of how this therapy can be used to help patients with PMBCL.

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
The patient undergoes an initial assessment to confirm eligibility for the trial. This includes a review of medical history and current health status.
Eligibility criteria include being over 18 years old, having a confirmed diagnosis of primary mediastinal large B-cell lymphoma, and having relapsed or refractory disease after first-line therapy.
Step 2
Leukapheresis procedure
The patient undergoes a leukapheresis procedure to collect white blood cells. This is necessary for the preparation of the CAR T-cells.
Adequate vascular access is required for this procedure, which may involve a peripheral or central venous line.
Step 3
CAR T-cell preparation
The collected white blood cells are used to prepare the CAR T-cells, specifically axicabtagene ciloleucel.
This process involves modifying the cells to target and attack the lymphoma cells.
Step 4
Pre-infusion conditioning
Before receiving the CAR T-cell infusion, the patient may undergo conditioning therapy. This is to prepare the body to accept the modified cells.
The specifics of this conditioning therapy are determined by the study physician.
Step 5
CAR T-cell infusion
The patient receives an infusion of the prepared CAR T-cells, known as axicabtagene ciloleucel.
This is administered as a dispersion for infusion, with the goal of targeting and eliminating lymphoma cells.
Step 6
Post-infusion monitoring
After the infusion, the patient is closely monitored for any side effects or reactions.
Regular assessments are conducted to evaluate the response to the treatment, including imaging tests like PET-CT or PET-MRI.
Step 7
Follow-up assessments
The patient undergoes follow-up assessments to determine the efficacy of the treatment.
The primary endpoint is the complete metabolic response rate at 3 months post-infusion, assessed through imaging tests.

Who can join the trial?

15 criteria

Must sign a written informed consent form, which is a document that explains the study and confirms your agreement to participate.
Must be older than 18 years.
Must have an ECOG performance status of less than 2. This is a scale that measures your ability to perform daily activities, with lower numbers indicating better function.
Must have a confirmed diagnosis of primary mediastinal B-cell lymphoma (PMBCL), a type of cancer, based on specific medical guidelines.
Must have received adequate first-line therapy, which includes:
- An anti-CD20 monoclonal antibody, such as rituximab.
- CHOP or CHOP-like chemotherapy, which are specific types of cancer treatments.
- Must have relapsed or refractory disease after initial treatment, as confirmed by a PET-CT scan. This means the cancer has returned or not responded to treatment.
- At least 2 weeks must have passed since any previous cancer treatment when you agree to participate.
- Must have lymphoma tissue available for examination and additional studies.
- Must have at least one measurable lesion, which is a detectable area of cancer, on a CT scan.
- Must be eligible for CAR T-cell therapy, a type of treatment that uses your own immune cells to fight cancer, and have suitable veins for a procedure called leukapheresis.
- Must have adequate function of bone marrow, kidneys, liver, heart, and lungs, as determined by specific medical tests.
- Females who can have children must have a negative pregnancy test.
- Sexually active men and women who can have children must agree to use effective birth control methods during the study and for 12 months after the last treatment.
- Must agree not to drive a vehicle for 8 weeks after receiving CAR T-cell treatment.

Who cannot join the trial?

4 criteria

Patients with other types of cancer besides Primary Mediastinal Large B-Cell Lymphoma (PMBCL) cannot participate. PMBCL is a type of cancer that starts in a part of the chest called the mediastinum.
Patients who have not experienced a return or worsening of PMBCL after treatment cannot participate. This is referred to as r/r PMBCL, meaning "relapsed or refractory," which describes cancer that has come back or is not responding to treatment.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study but is not specified here.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible to participate.

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Verified sites

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

Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Goethe University Frankfurt
Verified
Frankfurt, Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Verified
Ulm, Germany

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Investigated drugs

Axicabtagene Ciloleucel is a type of therapy known as CAR T-cell therapy. It involves modifying a patient's own T-cells, which are a type of white blood cell, to better recognize and attack cancer cells. This therapy is specifically used for patients with relapsed or refractory primary mediastinal B-cell lymphoma, a type of cancer that affects the lymphatic system. The goal of this treatment is to achieve a complete metabolic response, meaning the cancer cells are no longer active.

Axicabtagene Ciloleucel

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 relapsed or refractory primary mediastinal large B-cell lymphoma (PMBCL). The main therapeutic indication is for patients who have not responded to other treatments. At the molecular level, axicabtagene ciloleucel works by modifying a patient's own T-cells to better recognize and attack cancer cells. It is classified as a CAR T-cell therapy, which is a type of immunotherapy that harnesses the body's immune system to fight cancer.

Investigated diseases

Primary mediastinal large B-cell lymphoma – This is a type of non-Hodgkin lymphoma that originates in the thymus, located in the mediastinum, which is the central part of the chest. It primarily affects young adults and is characterized by the rapid growth of large B-cells, a type of white blood cell. The disease often presents with symptoms such as cough, chest pain, and difficulty breathing due to the mass effect in the chest area. As it progresses, it may spread to other parts of the body, including lymph nodes and organs. The condition is considered rare and requires specialized medical attention for management.