Study on Lisocabtagene Maraleucel for Adults with Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Non-Hodgkin Lymphoma (NHL), specifically a subtype known as indolent B-cell Non-Hodgkin Lymphoma. This includes conditions like follicular lymphoma and marginal zone lymphoma. These are cancers that affect a type of white blood cell called B-cells, which are part of the immune system. The study is testing a treatment called Lisocabtagene maraleucel, also known by its code name JCAR017. This treatment is a form of gene therapy where a patient’s own T cells, another type of white blood cell, are modified outside the body to better recognize and attack cancer cells when reintroduced into the body.

The purpose of the study is to evaluate how effective and safe JCAR017 is for patients whose cancer has returned or has not responded to previous treatments. Participants in the study will receive the treatment through an injection into a vein. The study will follow the participants over a period to observe how their cancer responds to the treatment and to monitor any side effects they may experience. Some participants may receive a placebo, which is a substance with no active treatment, to compare the effects of the actual treatment.

Throughout the study, various assessments will be conducted to measure the response of the cancer to the treatment, including imaging tests like PET-CT or CT scans. The study will also look at how long the treatment effects last, the overall survival of participants, and any changes in their quality of life. The safety of the treatment will be closely monitored to ensure the well-being of all participants. This study aims to provide valuable information on the potential benefits and risks of using JCAR017 for treating these types of lymphoma.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical history, and current health status.

The study focuses on individuals with a type of cancer affecting B-cells, known as relapsed or refractory indolent B-cell Non-Hodgkin Lymphoma (NHL).

2 leukapheresis procedure

A procedure called leukapheresis is performed to collect white blood cells from the bloodstream. This is necessary for the preparation of the treatment.

3 lymphodepleting chemotherapy

Before receiving the main treatment, a short course of chemotherapy is administered to reduce the number of existing immune cells. This helps the new treatment work more effectively.

During this period, it is important to follow specific guidelines, such as avoiding blood donation and using effective contraception if applicable.

4 administration of lisocabtagene maraleucel

The main treatment involves the administration of lisocabtagene maraleucel, a cell suspension for injection, given through an intravenous route.

This treatment is designed to target and destroy cancerous B-cells.

5 monitoring and follow-up

After receiving the treatment, regular monitoring is conducted to assess the response to the therapy and to ensure safety.

This includes various assessments such as imaging tests to evaluate the cancer’s response and regular health check-ups.

6 long-term follow-up

Long-term follow-up is necessary to monitor the overall health and any potential late effects of the treatment.

This phase continues for a significant period, ensuring comprehensive evaluation of the treatment’s efficacy and safety.

Who Can Join the Study?

The patient must have a type of lymphoma called follicular lymphoma (FL) or marginal zone lymphoma (MZL) confirmed by a test within 6 months before joining the study.
The patient must have good vascular access for a procedure called leukapheresis, which involves collecting white blood cells.
The patient must agree not to donate blood, organs, sperm, semen, or egg cells for at least 1 year after receiving a specific type of chemotherapy.
Females who can have children must have two negative pregnancy tests and agree to use effective birth control or abstain from heterosexual contact during the study and for 12 months after chemotherapy. They must also agree not to breastfeed during this time.
Male patients must agree to use a condom during sexual contact with a pregnant female or a female who can have children for 12 months after chemotherapy, even if they have had a vasectomy.
The patient must have relapsed (the disease has returned) or refractory (the disease does not respond to treatment) lymphoma.
The patient must have a measurable disease, meaning the lymphoma can be seen and measured using medical imaging tests.
The patient must have received a certain number of previous treatments, depending on their specific group in the study. These treatments must include specific types of drugs and therapies.
The patient must be at least 18 years old when they sign the consent form to join the study.
If the patient has had previous treatment targeting a protein called CD19, they must have a biopsy showing CD19-positive lymphoma after that treatment.
The patient must have a good performance status, meaning they are able to carry out daily activities with little or no assistance.
The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.

Who Cannot Join the Study?

Patients who have a different type of cancer that is not the specific type being studied.
Patients who have had a recent infection that is not fully resolved.
Patients who are currently pregnant or breastfeeding.
Patients who have a history of severe allergic reactions to similar treatments.
Patients who have another serious medical condition that could interfere with the study.
Patients who are unable to follow the study procedures for any reason.
Patients who have received certain treatments recently that could affect the study results.
Patients who have a history of substance abuse that could interfere with the study.
Patients who are participating in another clinical trial at the same time.
Patients who have had a major surgery recently and have not fully recovered.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Staedtisches Klinikum Karlsruhe gGmbH	Karlsruhe	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Karolinska University Hospital	Solna	Sweden
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Uhbdiexogc Hksjttei Cyirwif	Cologne	Germany
Kyghveot dcv Uonccpcrnqji Mxfplzsz Akh	Munich	Germany
Abubiuo Ojxezzvhjtk Pavv Gredkmqc Xhngo	Bergamo	Italy
Hczmyuzk Vzmw dyyvkyid	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.06.2020
France	Not recruiting	01.06.2020
Germany	Not recruiting	01.06.2020
Italy	Not recruiting	01.06.2020
Spain	Not recruiting	01.06.2020
Sweden	Not recruiting	01.06.2020

Trial locations

Investigated drugs:

Lisocabtagene Maraleucel

JCAR017 is a type of therapy used in this clinical trial. It is designed to treat adults with certain types of non-Hodgkin lymphoma, specifically those whose disease has returned or has not responded to previous treatments. JCAR017 is a form of CAR T-cell therapy, which involves modifying a patient’s own immune cells to better recognize and attack cancer cells. This therapy aims to improve the effectiveness of the immune system in targeting and destroying lymphoma cells.

Investigated diseases:

Follicular Lymphoma – This is a type of non-Hodgkin lymphoma that typically grows slowly and affects B-cells, which are a type of white blood cell. It often presents with painless swelling of lymph nodes, fatigue, and sometimes fever or night sweats. Over time, the disease can progress and may transform into a more aggressive form of lymphoma. It is characterized by periods of remission and relapse, where symptoms may improve and then return. The disease is considered indolent, meaning it progresses slowly compared to other types of lymphoma.

Marginal Zone Lymphoma – This is another type of indolent B-cell non-Hodgkin lymphoma that originates in the marginal zone of lymphoid tissue. It often affects the spleen, lymph nodes, or mucosal-associated lymphoid tissue. Symptoms can include swollen lymph nodes, abdominal pain, or discomfort due to an enlarged spleen. The disease progresses slowly and may remain stable for years before requiring treatment. It can sometimes be associated with chronic infections or autoimmune disorders. Like other indolent lymphomas, it is characterized by a pattern of relapse and remission.

Trial ID:

2024-510966-18-00

Protocol code:

JCAR017-FOL-001

NCT ID:

NCT04245839

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Lisocabtagene Maraleucel for Adults with Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma

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