Study Comparing Axicabtagene Ciloleucel and Standard Treatment for Adults with High-Risk Large B-Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called high-risk large B-cell lymphoma, which includes subtypes like diffuse large B-cell lymphoma and high-grade B-cell lymphoma. The trial aims to compare the effectiveness of a new treatment called axicabtagene ciloleucel with the standard treatments currently used for this condition. Axicabtagene ciloleucel is a type of therapy that involves modifying a patient’s own immune cells to better fight cancer.

Participants in the study will receive either axicabtagene ciloleucel or standard treatments, which may include medications such as prednisone, cyclophosphamide, dexamethasone, vincristine, tocilizumab, doxorubicin, diphenhydramine, rituximab, etoposide, mesna, methylprednisolone, fludarabine, and other analgesics and antipyretics. Some participants may receive a placebo. The study will monitor how well the treatments work by looking at how long participants live without the cancer getting worse and other health outcomes.

The trial will take place over a period of time, during which participants will receive their assigned treatment and have regular check-ups to monitor their health and the progress of the treatment. The goal is to determine which treatment is more effective in improving the lives of people with high-risk large B-cell lymphoma. Participants will be closely monitored for any side effects or changes in their condition throughout the study.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the new treatment called axicabtagene ciloleucel, and the other group will receive the standard treatment for high-risk large B-cell lymphoma.

2 treatment preparation

If you are assigned to the axicabtagene ciloleucel group, you will undergo a process called leukapheresis. This involves collecting your white blood cells, which will be modified and used to create the treatment.

You may receive medications such as fludarabine and cyclophosphamide through an intravenous infusion to prepare your body for the treatment. These medications help to create a suitable environment for the modified cells to work effectively.

3 receiving the treatment

The axicabtagene ciloleucel treatment is given as a single intravenous infusion. This means the modified cells are delivered directly into your bloodstream through a vein.

If you are in the standard treatment group, you will receive the usual medications for your condition, which may include drugs like rituximab, etoposide, and prednisone. These are also administered through intravenous infusion or orally, depending on the specific medication.

4 monitoring and follow-up

After receiving the treatment, you will be closely monitored for any side effects or changes in your condition. This includes regular check-ups and tests to assess your response to the treatment.

You may be asked to complete questionnaires about your quality of life and any symptoms you experience. This information helps to evaluate the impact of the treatment on your daily life.

5 long-term follow-up

The study will continue to follow your progress for several years to gather information on the long-term effects and benefits of the treatment.

Regular visits and assessments will be scheduled to monitor your health and any ongoing effects of the treatment.

Who Can Join the Study?

Must be an adult aged 18 years or older.
Must have a type of lymphoma called large B-cell lymphoma (LBCL), which includes diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).
Must have a high-risk disease with an IPI score of 4 or 5 at the initial diagnosis. (IPI stands for International Prognostic Index, which helps to assess the risk level of lymphoma.)
Must have Ann Arbor Stage III or IV disease, which indicates advanced stages of lymphoma.
Must have received only one cycle of a specific type of chemotherapy called R-chemotherapy.
Must have at least one measurable tumor based on a CT scan, with specific size requirements for lymph nodes and other lesions.
Must have a tumor sample available for review by a central pathology lab.
Females of childbearing potential must have a negative pregnancy test. (Females who have had surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential.)
Must have an ECOG performance status of 0-2 at the time of randomization. (ECOG is a scale used to assess how a disease affects a patient’s daily living abilities.)
Must have adequate function of bone marrow, kidneys, liver, lungs, and heart, as indicated by specific medical tests and criteria.
Must have a baseline oxygen level greater than 92% on room air.

Who Cannot Join the Study?

Patients who have had another type of cancer in the past, except for certain skin cancers or cervical cancer that has been treated.
Patients who have an active infection that needs treatment.
Patients who have a history of severe allergic reactions to certain medications.
Patients who have a serious heart condition.
Patients who have a serious lung condition.
Patients who have a serious liver condition.
Patients who have a serious kidney condition.
Patients who are pregnant or breastfeeding.
Patients who have received certain treatments for their lymphoma in the past.
Patients who have a condition that affects their immune system.
Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Medical University Of Vienna	Vienna	Austria
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
University Hospital Maastricht	Maastricht	The Netherlands
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Oncopole Claudius Regaud	Toulouse	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Noe LGA Gesundheit Region Mitte GmbH	St. Poelten	Austria
Ospedale San Raffaele S.r.l.	Milan	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Hospital Santa Maria Della Misericordia	Perugia	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Centre Hospitalier Universitaire De Nice	Nice	France
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Universita Degli Studi Di Brescia	Brescia	Italy
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
SCRI CCCIT Ges.m.b.H.	Salzburg	Austria
Hopital Saint Eloi	Montpellier	France
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Agowvswee Ubz	Amsterdam	The Netherlands
Cgopvw Lbmg Bxbhhu	Lyon	France
Lagfk Uyolkovmehtx Mdllrub Cgluugs (swzkk	Leiden	The Netherlands
Hlylphcw Ugilbtbtjjumr Mxlrsix Dd Vghregvxvt	Santander	Spain
Cmygwc Hrsredscxwb Urgmlvpxhhhkg Do Dggqs	Dijon	France
Usyegvcelwgkizqtysslw Dsobnfonzmm Aza	Duesseldorf	Germany
Adnevsh Ufypx Sjzfyuksw Llmwiq Da Bftcpdw	Bologna	Italy
Uhdaottraznz Magpbcw Cgkdnrr Gkvtcdfuy	Groningen	The Netherlands
Iislpcen Cyobmq Dvaengfchtpiwwdsj	L'hospitalet De Llobregat	Spain
Hszdjxy Hsksn Mssjvh &pvbefi 1 rck Geskhlv Eimnff	Creteil	France
Hgfarzkl Vrgd dujtagbl	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.10.2023
France	Recruiting	01.10.2023
Germany	Recruiting	01.10.2023
Italy	Recruiting	01.10.2023
Portugal	Recruiting	01.10.2023
Spain	Recruiting	01.10.2023
The Netherlands	Recruiting	01.10.2023

Trial locations

Investigated drugs:

Axicabtagene Ciloleucel is a type of therapy that uses your own immune cells to fight cancer. In this treatment, some of your white blood cells, which are part of your immune system, are taken out of your body. These cells are then changed in a lab to help them recognize and attack cancer cells more effectively. After this process, the modified cells are put back into your body to help fight the lymphoma. This therapy is being tested to see if it works better than the usual treatments for people with a type of cancer called high-risk large B-cell lymphoma.

Investigated diseases:

Diffuse large B-cell lymphoma

Diffuse Large B-Cell Lymphoma, Not Otherwise Specified (DLBCL, NOS) – This is a type of non-Hodgkin lymphoma characterized by the rapid growth of large B-cells in the lymphatic system. It typically begins in the lymph nodes but can also affect other organs. The disease progresses quickly, with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. As it advances, it can spread to other parts of the body, including the bone marrow and central nervous system. The progression involves the uncontrolled proliferation of abnormal B-cells, which can disrupt normal immune function.

High-Grade B-Cell Lymphoma (HGBL) – This is an aggressive form of non-Hodgkin lymphoma that involves rapidly growing B-cells. It often presents with symptoms like enlarged lymph nodes, fever, and fatigue. The disease progresses swiftly, with the potential to spread beyond the lymphatic system to other organs. It is characterized by a high proliferation rate of malignant cells, leading to a quick deterioration of the patient’s condition. The rapid growth of these cells can cause significant disruption to normal bodily functions.

Trial ID:

2022-501489-24-00

Protocol code:

KT-US-484-0136

NCT ID:

NCT05605899

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Axicabtagene Ciloleucel and Standard Treatment for Adults with High-Risk Large B-Cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?