Long-Term Follow-Up Study for Patients Treated with Idecabtagene Vicleucel or Lisocabtagene Maraleucel for Cancer

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What is this study about?

This clinical trial is focused on understanding the long-term effects of treatments involving gene-modified T cells. These treatments are used for patients who have previously participated in studies sponsored by Celgene Corporation. The study includes patients who have received at least one infusion of these specially modified cells. The main goal is to assess any delayed side effects that might occur after receiving these treatments. The study will also monitor how long these modified cells remain in the body and check for any potential issues, such as the development of new viruses or changes in the patient’s health status over time.

The trial involves two specific treatments: idecabtagene vicleucel and lisocabtagene maraleucel. These are advanced therapies that use a patient’s own immune cells, which are modified to better fight certain diseases. The study will follow patients over a long period to ensure their safety and to gather information on the effectiveness of these treatments. This includes looking at any new health conditions that might arise and tracking the overall health and development of younger patients who received the treatment.

Throughout the study, researchers will collect data on various health aspects, such as the presence of the modified cells in the body and any new health issues that could be linked to the treatment. The study aims to provide a comprehensive understanding of the long-term safety and benefits of using **gene-modified T cells** in treating diseases. This information will help improve future treatments and ensure they are safe and effective for patients.

1 joining the study

Upon joining the study, it is necessary to sign an informed consent form. This form confirms understanding of the study and agreement to participate.

For participants under 18, a parent or legal representative must also sign an informed assent form.

2 initial assessment

An initial assessment is conducted to gather baseline information. This may include a physical examination and review of medical history.

The purpose is to ensure eligibility and gather data for future comparisons.

3 treatment monitoring

Participants who have previously received genetically modified T cells will be monitored for delayed adverse events. This includes checking for new or worsening conditions.

Regular follow-up visits are scheduled to assess the long-term effects of the treatment.

4 long-term follow-up

The study involves long-term follow-up to monitor the persistence of genetically modified T cells in the body.

This includes analysis of the cells and checking for any replication-competent lentiviruses, which are viruses that can reproduce.

5 growth and maturity assessment

For participants under 18 at the time of treatment, assessments of physical growth and sexual maturity are conducted.

These assessments help understand the impact of the treatment on development.

6 safety and efficacy evaluation

The study evaluates the safety of the treatment by monitoring for any new health issues related to the therapy.

The efficacy of the treatment is also assessed by tracking disease status, progression, and overall survival.

Who Can Join the Study?

  • All adult and pediatric subjects who have received at least one infusion of genetically modified (GM) T cells in a previous study sponsored by Celgene or its partners.
  • The subject, or their parent/legal representative if applicable, must understand and voluntarily sign an Informed Consent Form (ICF) or Informed Assent Form (IAF) before any study-related assessments or procedures are conducted. An Informed Consent Form is a document that explains the study and any potential risks, ensuring that participants understand and agree to take part.
  • The subject must be willing and able to follow the study visit schedule and other requirements of the study protocol.

Who Cannot Join the Study?

  • Patients who have not received at least one infusion of genetically modified T cells in a previous Celgene sponsored study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Institut Jules Bordet Anderlecht Belgium
Centre Hospitalier Universitaire De Montpellier Montpellier France
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Staedtisches Klinikum Karlsruhe gGmbH Karlsruhe Germany
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Instytut Hematologii I Transfuzjologii Warsaw Poland
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Hospital Universitario Virgen De Las Nieves Granada Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Pohjois-Pohjanmaan hyvinvointialue Oulu Finland
Szpital Specjalistyczny Nr I W Bytomiu SPZOZ Bytom Poland
Evangelismos S.A. Athens Greece
University Of Debrecen Debrecen Hungary
Institutul Regional De Oncologie Iasi Iasi Romania
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Klinikum Chemnitz gGmbH Chemnitz Germany
Stichting Radboud University Medical Center Nijmegen The Netherlands
IRCCS Ospedale Policlinico San Martino Genoa Italy
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse Vienna Austria
Universidade De Santiago De Compostela Santiago De Compostela Spain
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
General University Hospital Of Patras Patras Greece
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Region Midtjylland Aarhus Denmark
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Centre Hospitalier Universitaire De Rennes Rennes France
Rigshospitalet Copenhagen Denmark
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Centre Hospitalier Universitaire De Poitiers Poitiers France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitair Ziekenhuis Gent Gent Belgium
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Hospital Universitario 12 De Octubre Madrid Spain
Vrije Universiteit Brussel Jette Belgium
Servei De Salut De Les Illes Balears Palma Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Region Sjaelland Holbæk Denmark
University Hospital Ostrava Ostrava Czechia
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Fundeni Clinical Institute Bucharest Romania
Vuitmgbyzwjqgrmg hdyizhueoietxeu Turku Finland
Azaieqpjnx Pzymyobu Hscohwsr Db Ppknv Paris France
Uiyxadhxrk Mcxqzcd Coolwp Htkwxgshtpvklctua Hamburg Germany
Uwntjcvoyjuffcrlngdwz Eojgu Avh Essen Germany
Ohmpujmwenyamg Lmbt Gdfo Linz Austria
Hnmobefz Upuposzlhvjrk Moijmxv De Vmnegnjjjj Santander Spain
Wstykjfsytr Wwqbhmwnzbhtrcbqrluj Cxwitbg Oywyijsrd I Twycfqpeoixgm Id Mezasxdmsto W Lfhgq Lodz Poland
Agnywmh Udxbf Snykxlnph Ljywvb Dg Bdwdhtu Bologna Italy
Ubxxaqmzim Hjycwwqx Cxandbp Cologne Germany
Frdwdwuk nlxatnrog Mzrdx a Hzeeozt Prague Czechia
Apgxraibx Uho Amsterdam The Netherlands
Uzuinxnilimhwjrvmxept Dwkzijhairs Arg Duesseldorf Germany
Hbtcimfj Urdpuqamkj Cinbekn Hmwdbkia Helsinki Finland
Eklarzo Ucqopslpqxvc Mbhpnve Cftobes Rzqvrwiwm (dmchehs Mgf Rotterdam The Netherlands
Aiwrkcc Omdehxmovny Usuoeohyjclya Coatzfjsueqq Djiif Suheye E Dbbth Stwjloh Du Tocivl Turin Italy
Nzpribit Idlzzlet Oefownkbx Ibo Mbcvy Sbyqazgwedsdiirykcxsdkiupwjp Imistrcf Brkirlzt Cracow Poland
Grcuhe Uxftrokyrk Fhwmkzfno Frankfurt Germany
Khhrxuil dxi Uxyjoqwbrmre Muqbrsmm Abv Munich Germany
Uvtxacilmlpdbtqzvtszf Wwxzxecsy Afl Wuerzburg Germany
Urirjdorqxlbew Ckjwaov Kkpzltigm Gdansk Poland
Hwphglev Dh Ln Sajrg Cfez I Sxkr Pwa Barcelona Spain
Udfprqrjzo Ov Awbcybv Edegem Belgium
Appwpee Odqgydoatir Pwgl Gaddcpgu Xvdui Bergamo Italy
Hvbzgown Uqavootossvor Hspzdgpz Tueuw y Plmzvt Ijqotloo Carzjh divqlkkalmtapzrvs (drxs Badalona Spain
Hcvxrhqh Vsse dasuzjbf Barcelona Spain
Ujsvblbfvu Gejuhmn Hnwnxxzp Aejdxpb Athens Greece
Httoikdm Ujrhhbqryciwnr Sndjcetxnz &rojapa Hwjoawo dj Hdlkxdncoib STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
02.04.2018
Belgium Belgium
Recruiting
02.04.2018
Czechia Czechia
Not yet recruiting
02.04.2018
Denmark Denmark
Not yet recruiting
02.04.2018
Finland Finland
Recruiting
02.04.2018
France France
Recruiting
02.04.2018
Germany Germany
Recruiting
02.04.2018
Greece Greece
Not yet recruiting
02.04.2018
Hungary Hungary
Not yet recruiting
02.04.2018
Italy Italy
Recruiting
02.04.2018
Norway Norway
Recruiting
02.04.2018
Poland Poland
Recruiting
02.04.2018
Portugal Portugal
Not yet recruiting
02.04.2018
Romania Romania
Recruiting
02.04.2018
Spain Spain
Recruiting
02.04.2018
Sweden Sweden
Recruiting
02.04.2018
The Netherlands The Netherlands
Recruiting
02.04.2018

Trial locations

Gene-Modified T Cells are a type of therapy where a patient’s own immune cells, specifically T cells, are altered in a laboratory to better recognize and attack cancer cells. This process involves collecting T cells from the patient, modifying them to enhance their ability to fight cancer, and then reintroducing them into the patient’s body. The goal of this therapy is to improve the body’s natural ability to combat cancer by using these enhanced T cells. In this trial, the focus is on understanding the long-term effects and safety of these modified cells, as well as their effectiveness in treating cancer over an extended period.

Neurologic Disorder – Neurologic disorders involve the nervous system, which includes the brain, spinal cord, and nerves. These disorders can affect movement, communication, and cognitive functions. Symptoms may develop gradually or suddenly and can include muscle weakness, coordination problems, and changes in sensation. Over time, these disorders may lead to increased difficulty in performing daily activities. The progression can vary widely depending on the specific type of neurologic disorder.

Rheumatologic Disorder – Rheumatologic disorders affect the joints, muscles, and bones, often causing pain, swelling, and stiffness. These conditions can lead to decreased mobility and function over time. Symptoms may fluctuate, with periods of increased activity and remission. As the disorder progresses, it can result in joint damage and deformities. The severity and progression can differ significantly among individuals.

Autoimmune Disorder – Autoimmune disorders occur when the immune system mistakenly attacks the body’s own tissues. This can lead to inflammation and damage in various organs and systems. Symptoms often include fatigue, fever, and general malaise, along with specific organ-related symptoms. The progression can be unpredictable, with periods of flare-ups and remission. Over time, chronic inflammation can lead to tissue damage and loss of function.

Hematologic Disorder – Hematologic disorders affect the blood and blood-forming organs, impacting the production and function of blood cells. These disorders can lead to symptoms such as fatigue, weakness, and increased susceptibility to infections. As the condition progresses, it may cause complications like anemia, bleeding disorders, or clotting issues. The progression and impact on health can vary depending on the specific type of hematologic disorder.

Infection – Infections are caused by microorganisms such as bacteria, viruses, fungi, or parasites invading the body. They can lead to symptoms like fever, fatigue, and localized pain or swelling. The progression of an infection depends on the type of microorganism and the body’s immune response. Some infections resolve quickly, while others can persist and cause chronic health issues. The severity and duration can vary widely among different infections.

Second Primary Malignancy (SPM) – A second primary malignancy is a new cancer that occurs in an individual who has previously been diagnosed with cancer. This new cancer is distinct from any recurrence or spread of the original cancer. The development of an SPM can be influenced by genetic factors, previous cancer treatments, or environmental exposures. The progression of an SPM depends on the type and location of the new cancer. It requires separate evaluation and management from the initial cancer.

Trial ID:
2023-504201-36-00
Protocol code:
GC-LTFU-001
NCT ID:
NCT03435796
Trial Phase:
Therapeutic use (Phase IV)

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