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Study of Tabelecleucel for Patients with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Transplant Treatment Failure

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What is this study about?

This clinical trial is focused on studying a condition known as Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD). This disease can occur in patients who have undergone organ or cell transplants and is associated with the Epstein-Barr virus. The study is investigating a treatment called tabelecleucel, also known by its code name ATA129. Tabelecleucel is a type of cell therapy that uses specially prepared cells to target and fight the virus-related disease.

The purpose of the study is to determine the clinical benefit of tabelecleucel in patients with EBV+ PTLD who have not responded to previous treatments, such as rituximab or rituximab combined with chemotherapy. Participants in the study will receive tabelecleucel through an injection into their veins. The study will monitor how well the treatment works and how the disease responds over time.

Participants will be observed throughout the study to assess the effects of the treatment. The study aims to provide valuable information on the effectiveness of tabelecleucel for patients with EBV+ PTLD, offering insights into potential new treatment options for those who have not had success with existing therapies. The study is expected to continue until 2027, allowing researchers to gather comprehensive data on the treatment’s impact.

1 joining the study

Upon joining the study, eligibility is confirmed based on previous organ or cell transplantation and a diagnosis of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD).

The availability of a suitable partially matched tabelecleucel is verified.

2 treatment initiation

The treatment involves the administration of tabelecleucel, a dispersion for injection, given intravenously.

The dosage ranges from 2.8 × 10^7 to 7.3 × 10^7 cells/mL.

3 treatment administration

Tabelecleucel is administered intravenously. The frequency and duration of administration are determined by the study protocol and the patient’s response to treatment.

4 monitoring and assessment

Regular monitoring is conducted to assess the response to treatment using imaging techniques such as positron emission tomography (PET) or magnetic resonance imaging (MRI) as appropriate.

The objective response rate (ORR) is evaluated to determine the clinical benefit of the treatment.

5 completion of treatment

The study aims to measure the duration of response (DOR) and overall survival (OS) among participants.

The study is estimated to conclude by June 15, 2027.

Who Can Join the Study?

  • The patient must have had a prior solid organ transplant (like kidney, liver, heart, lung, pancreas, or small bowel) or a prior allogeneic hematopoietic cell transplant (a type of bone marrow transplant).
  • The patient or their representative must be willing and able to sign a written consent form to participate in the study.
  • The patient must have a confirmed diagnosis of a specific disease called EBV+ PTLD, which is related to the Epstein-Barr virus.
  • The study sponsor must confirm that the patient has access to a suitable treatment called tabelecleucel, which is partially matched to their immune system.
  • The patient must have a measurable disease that shows up on specific imaging tests like PET scans or MRI, which are used to see how the disease is responding to treatment.
  • The patient must have previously tried a treatment called rituximab (or a similar drug) and it did not work, or they had a relapse after treatment. This applies to those who had a solid organ transplant or a bone marrow transplant.
  • Both males and females of any age can participate.
  • For patients aged 16 and older, they must have a performance status of 3 or less, which is a measure of their ability to perform daily activities. For those under 16, they must have a Lansky score of 20 or more, which is a similar measure for children.
  • For patients who had a bone marrow transplant due to certain blood cancers, their original disease must be in remission, meaning it is not currently active.
  • The patient must have adequate organ function, which includes:
    • A certain level of white blood cells called neutrophils, which help fight infection.
    • A certain level of platelets, which help with blood clotting.
    • Liver function tests (ALT, AST, and bilirubin) must be within acceptable limits, unless the doctor believes the liver issues are due to the disease being studied.

Who Cannot Join the Study?

  • Patients who have not experienced failure of previous treatments like rituximab or chemotherapy. Rituximab is a medication used to treat certain types of diseases, including some cancers.
  • Patients who have not undergone a solid organ transplant or allogeneic hematopoietic cell transplant. A solid organ transplant involves replacing a failing organ, like a kidney or liver, with a healthy one from a donor. An allogeneic hematopoietic cell transplant is a procedure where a patient receives blood-forming stem cells from a donor.
  • Patients who are not part of the specific groups being studied, such as those who have not received a commercial product or a similar treatment process.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet other specific health criteria required for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hopital Necker Enfants Malades Paris France
Hospital Universitario Y Politecnico La Fe Valencia Spain
Medical University Of Vienna Vienna Austria
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Hopitaux Universitaires Pitie Salpetriere Paris France
Centre hospitalier universitaire de Liege Liege Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Virgen del Rocío University Hospital Sevilla Spain
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Hotmtnqr Uwjkchwejzibu Mtvnotk Dp Vndcixlgnu Santander Spain
Isidzvlf Cjvaxv Dqrleggdvuwnjrdql L'hospitalet De Llobregat Spain
Akalwhx Oggbgqoliza Usgnkbwelkiyo Cpggqmsbmaoi Dmfnq Sgcxqk E Dgqke Sxbtpie Dt Tjkcli Turin Italy
Hyfdaxsv Vlsj drjmufow Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
15.06.2020
Belgium Belgium
Not recruiting
15.06.2020
France France
Not recruiting
15.06.2020
Italy Italy
Not recruiting
15.06.2020
Spain Spain
Recruiting
15.06.2020

Trial locations

Investigated drugs:

Tabelecleucel (ATA129) is a type of therapy that uses special immune cells called T cells. These T cells are designed to target and destroy cells infected with the Epstein-Barr virus (EBV). This therapy is being studied for patients who have developed a condition called post-transplant lymphoproliferative disease (PTLD) after receiving a solid organ or bone marrow transplant. The goal is to see if these specially prepared T cells can help control or eliminate the disease when other treatments, like rituximab or chemotherapy, have not worked.

Rituximab is a medication that is often used to treat certain types of cancer and autoimmune diseases. It works by targeting a specific protein found on the surface of certain immune cells, leading to their destruction. In this study, rituximab is used as a previous treatment for patients with post-transplant lymphoproliferative disease, and the trial is looking at patients for whom rituximab alone or in combination with chemotherapy did not succeed.

Chemotherapy refers to a group of medications that are used to kill or stop the growth of cancer cells. In this trial, chemotherapy is used in combination with rituximab for some patients. The study is focused on patients who did not respond to this combination treatment, exploring whether tabelecleucel can provide additional benefits.

Investigated diseases:

Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease – This disease occurs in individuals who have undergone organ or stem cell transplants and is linked to the Epstein-Barr virus. It involves the abnormal growth of lymphoid cells, which are a type of white blood cell. The disease can manifest in various forms, ranging from benign growths to aggressive lymphomas. It typically develops due to the immunosuppressive medications used to prevent transplant rejection, which can allow the Epstein-Barr virus to reactivate. Symptoms may include fever, swollen lymph nodes, and organ dysfunction. The progression of the disease can vary, with some cases resolving spontaneously while others may require medical intervention.

Trial ID:
2024-516622-57-00
Protocol code:
ATA129-EBV-302
Trial Phase:
Therapeutic confirmatory (Phase III)

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