Study of Tisagenlecleucel for Adults with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying a treatment for aggressive B-cell non-Hodgkin lymphoma, a type of cancer that affects the lymphatic system. The treatment being tested is called tisagenlecleucel, also known by its code name CTL019. This treatment is a form of cell therapy, which involves using specially modified cells to target and fight cancer cells. The study aims to compare the effectiveness of tisagenlecleucel with the standard care treatments currently used for this type of lymphoma.

Participants in the study will receive either tisagenlecleucel or one of the standard care treatments, which may include medications such as fludarabine, ifosfamide, cisplatin, melphalan, oxaliplatin, carmustine, ibrutinib, lenalidomide, gemcitabine hydrochloride, rituximab, cyclophosphamide, bendamustine hydrochloride, tocilizumab, cytarabine, dexamethasone acetate, etoposide, or carboplatin. Some participants may receive a placebo. The purpose of the study is to see if tisagenlecleucel can delay the progression of the disease or improve survival compared to the standard treatments.

The study will involve regular assessments to monitor the participants’ health and the effectiveness of the treatment. These assessments will include medical tests and evaluations to track the progression of the lymphoma and any side effects of the treatments. The study is expected to continue until 2026, with participants being closely monitored throughout the trial period to ensure their safety and to gather comprehensive data on the treatment’s impact.

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 may be performed to ensure adequate organ function and to confirm the diagnosis of aggressive B-cell non-Hodgkin lymphoma.

2 leukapheresis

Leukapheresis is a procedure to collect white blood cells, which are used to manufacture the personalized treatment, tisagenlecleucel.

3 pre-treatment

Before receiving tisagenlecleucel, a pre-treatment regimen is administered. This may include medications such as fludarabine and cyclophosphamide given through intravenous infusion to prepare the body for the main treatment.

4 tisagenlecleucel infusion

The main treatment involves an infusion of tisagenlecleucel. This is a personalized therapy designed to target and treat the lymphoma.

5 monitoring and follow-up

After the infusion, regular monitoring is conducted to assess the response to treatment and to manage any side effects.

Follow-up visits are scheduled to evaluate the effectiveness of the treatment and to ensure the patient’s well-being.

6 additional treatments

Depending on the response to tisagenlecleucel, additional treatments may be administered. These could include medications like rituximab, ibrutinib, or gemcitabine.

7 end of trial

The trial concludes with a final assessment to determine the overall outcome of the treatment.

The estimated end date for the trial is February 14, 2026.

Who Can Join the Study?

You must sign a form to show you understand and agree to join the study.
You need to be at least 18 years old when you sign the form.
You must have a confirmed diagnosis of a type of aggressive B-cell non-Hodgkin lymphoma (NHL) that has come back or not responded well to initial treatment. This includes several specific subtypes of lymphoma.
Your lymphoma must have come back or gotten worse within 365 days after your last treatment with certain medications, or it must not have fully responded to initial treatment.
You should be eligible for a type of stem cell transplant, as determined by your doctor.
Your disease must be active and visible on certain scans, with specific size requirements for affected areas.
Your overall health should be good, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.
Your organs must be functioning well, including:
- Kidneys: Normal levels of creatinine or a good estimated filtration rate.
- Liver: Normal levels of certain enzymes and bilirubin, with some exceptions for specific conditions.
- Blood: Adequate levels of neutrophils, platelets, and hemoglobin.
- Lungs: No or mild breathing difficulty and good oxygen levels.
You must have a sample of your blood cells available for use in the study.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have not experienced a return or worsening of their cancer after treatment.
Patients who are not adults.
Patients who are unable to understand or agree to the study requirements.
Patients who have other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have received certain treatments recently that could affect the study results.
Patients who have allergies to the study medication or its ingredients.
Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Oslo Universitetssykehus HF	Oslo	Norway
Medical University Of Vienna	Vienna	Austria
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
SCRI CCCIT Ges.m.b.H.	Salzburg	Austria
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Unlmcjtcdc Mbnhjre Ctjzjk Huumawsnjyhkabzmn	Hamburg	Germany
Irbwujkv Cbiqmg Dyexbkiudohlekpgz	L'hospitalet De Llobregat	Spain
Aaifdnmfk Ukd	Amsterdam	The Netherlands
Hgcwczhf Vfwm dfmjyjbl	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	07.05.2019
France	Not recruiting	07.05.2019
Germany	Not recruiting	07.05.2019
Italy	Not recruiting	07.05.2019
Norway	Not recruiting	07.05.2019
Spain	Not recruiting	07.05.2019
The Netherlands	Not recruiting	07.05.2019

Trial locations

Investigated drugs:

Tisagenlecleucel is a type of therapy that uses the patient’s own immune cells to fight cancer. These cells are collected from the patient, modified in a laboratory to better recognize and attack cancer cells, and then infused back into the patient. This treatment is being tested for its effectiveness in treating aggressive B-cell non-Hodgkin lymphoma that has not responded to other treatments or has returned after treatment.

Standard of Care (SOC) refers to the usual treatment given for aggressive B-cell non-Hodgkin lymphoma. This can include a combination of chemotherapy, radiation therapy, and other medications that are typically used to treat this type of cancer. The trial is comparing the effectiveness of this standard treatment to the new therapy, tisagenlecleucel.

Investigated diseases:

Aggressive B-cell Non-Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting B-cells, which are a type of white blood cell. It is characterized by the rapid growth of malignant cells that can form tumors in lymph nodes and other parts of the body. The disease often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. As it progresses, it can spread to other organs and tissues, leading to more severe symptoms. The condition is considered aggressive due to its fast progression and the potential for widespread impact on the body.

Trial ID:

2023-508343-48-00

Protocol code:

CCTL019H2301

NCT ID:

NCT03570892

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Tisagenlecleucel for Adults with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?