Study Comparing Tisagenlecleucel with Standard Treatment for Adults with Relapsed or Refractory Follicular Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called follicular lymphoma, which is a form of non-Hodgkin lymphoma affecting the lymphatic system. The trial is specifically for adult patients whose disease has returned or has not responded to at least two previous treatments. The main treatment being tested in this study is called tisagenlecleucel, also known by its code name CTL019. This is a type of cell therapy that uses the patient’s own immune cells, which are modified to better fight cancer. The study will compare the effectiveness of tisagenlecleucel with the standard treatments currently used for this condition.

Participants in the study will receive either tisagenlecleucel or one of the standard treatments, which may include medications like rituximab, cyclophosphamide monohydrate, doxorubicin hydrochloride, vincristine sulfate, prednisone, prednisolone, fludarabine phosphate, lenalidomide, bendamustine hydrochloride, or tocilizumab. Some participants may receive a placebo. The purpose of the study is to determine if tisagenlecleucel can improve the time patients live without their disease getting worse, which is known as progression-free survival.

The study will involve regular visits to the clinic for treatment and monitoring. Participants will undergo various tests and assessments to track their health and the progress of their disease. The trial will last for several years, with the aim of gathering comprehensive data on the safety and effectiveness of tisagenlecleucel compared to standard treatments. This information will help determine the best treatment options for patients with relapsed or refractory follicular lymphoma.

1 enrollment and initial assessment

Upon joining the clinical trial, you will undergo an initial assessment to confirm eligibility. This includes a review of your medical history and a series of tests to ensure you meet the trial’s criteria.

You will be asked to sign an informed consent form, which explains the trial’s purpose, procedures, and potential risks and benefits.

2 randomization

After the initial assessment, you will be randomly assigned to one of two groups: the tisagenlecleucel treatment group or the standard of care group. This process is random to ensure unbiased results.

3 treatment phase

If assigned to the tisagenlecleucel group, you will receive this treatment through an intravenous infusion. The schedule and dosage will be determined by the study team based on your specific needs.

If assigned to the standard of care group, you will receive medications such as fludarabine phosphate, cyclophosphamide monohydrate, rituximab, and others as per the standard treatment protocol. These may be administered intravenously or orally, depending on the specific medication.

4 monitoring and follow-up

Throughout the trial, regular monitoring will be conducted to assess your response to the treatment. This includes physical exams, blood tests, and imaging studies like CT or PET scans.

You will be required to attend follow-up visits as scheduled by the study team to ensure your safety and to monitor the effectiveness of the treatment.

5 completion and final assessment

At the end of the treatment phase, a final assessment will be conducted to evaluate the overall response to the treatment. This will include a comprehensive review of your health status and any changes observed during the trial.

You will receive information about the next steps and any additional follow-up that may be necessary after the trial concludes.

Who Can Join the Study?

  • Must be at least 18 years old at the time of signing the consent form.
  • Must have follicular lymphoma grade 1, 2, or 3A confirmed by a test after the latest relapse.
  • Must have a disease that has come back or did not respond after at least two different treatments, including a treatment with an anti-CD20 antibody and an alkylating agent (types of cancer treatments).
  • The disease must be active on a PET scan (a type of imaging test) and measurable on a CT scan (another type of imaging test).
  • Must have an ECOG performance status of 0, 1, or 2 at screening. This is a scale that measures how well a person can perform daily activities, where 0 means fully active and 2 means unable to work but able to do all self-care.
  • Must have adequate function of blood, kidneys, liver, and lungs at screening.
  • Must meet the criteria to undergo leukapheresis (a procedure to collect white blood cells) unless this has been done before.
  • Must be eligible for treatment with the chosen standard care regimen.

Who Cannot Join the Study?

  • Patients who have not received at least two prior lines of systemic therapy for their condition.
  • Patients with medical conditions other than follicular B-cell non-Hodgkin lymphoma grade 1-3A that is relapsed (came back after treatment) or refractory (did not respond to treatment).
  • Patients who are not adults.
  • Patients who are part of a vulnerable population that requires special protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain

Other Sites

Site Name City Country Status
Narodny Onkologicky Ustav Bratislava Slovakia
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Universidade De Santiago De Compostela Santiago De Compostela Spain
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Hospital Ostrava Ostrava Czechia
Fundeni Clinical Institute Bucharest Romania
Oseqwqqmkpsqcd Lyub Gdyu Linz Austria
Uetnumamxnyydt Cqfilua Kimgyjyhn Gdansk Poland
Hqokplqe Di Lg Sjqku Cuqi I Sjub Pap Barcelona Spain
Hsptojsj Ubmmzjrenxktk Mydvszb Dr Vxfhrzzmpu Santander Spain
Iccjxlnm Cbjzcd Diqhrtevgxdqwdncn L'hospitalet De Llobregat Spain
Wjilhvsqrrz Wvocnwjjgerkbbrredsp Cpakgtc Ozejnmpvq I Togrnpihyhjpb If Msyagnaslwp W Lphal Lodz Poland
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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
20.12.2023
Czechia Czechia
Not recruiting
20.12.2023
Hungary Hungary
Not recruiting
20.12.2023
Poland Poland
Not recruiting
20.12.2023
Romania Romania
Not recruiting
20.12.2023
Slovakia Slovakia
Not recruiting
20.12.2023
Spain Spain
Not recruiting
20.12.2023

Trial locations

Tisagenlecleucel is a type of treatment known as CAR-T cell therapy. It involves taking some of your own immune cells, called T cells, and modifying them in a laboratory to better recognize and attack cancer cells. Once these modified cells are ready, they are infused back into your body to help fight the cancer. This therapy is specifically used for certain types of blood cancers, like follicular lymphoma, when other treatments have not worked.

Follicular B-cell non-Hodgkin lymphoma – This is a type of blood cancer that affects B-lymphocytes, a kind of white blood cell. It typically progresses slowly and is characterized by the formation of tumors in the lymph nodes. Over time, the disease can spread to other parts of the body, including the bone marrow and spleen. Patients may experience symptoms such as swollen lymph nodes, fatigue, and night sweats. The disease often goes through periods of remission and relapse. As it advances, it may transform into a more aggressive form of lymphoma.

Trial ID:
2023-503452-27-00
Protocol code:
CCTL019E2301
Trial Phase:
Therapeutic confirmatory (Phase III)

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