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

4 1 1

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
Institutul Regional De Oncologie Iasi Iasi Romania
University Hospital Ostrava Ostrava Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Fundeni Clinical Institute Bucharest Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
CHU UCL Namur Yvoir Belgium
Rgmsznwhuuopen Uhpdj Prague Czechia
Izirxaoy Jnckv Bapgcj Anderlecht Belgium
Uxippcatap Ow Dqtsrasj Debrecen Hungary
Enztcvxghwfpzprluelqbacymu Hcscpqfd oa Axwzto Athens Greece
Hbmjqzur Vkug djyxutlq Barcelona Spain
Vlrpvf did Raxxo Uaarcnzood Hdqofrog Sevilla Spain
Uybenurhxq Hcogohbg Calllva Cologne Germany
Fmziudyq neecnsmwh Mldfw a Hhrkayj Prague Czechia
Ozhaos Utjyejhmul Hwvtcduz Odense Denmark
Urrmrlvcpppnlcnbozvfp Egsutzsq Aio Erlangen Germany
Ubsopknokzvjikxvcaqyx Tgexclawj Ado Tuebingen Germany
Afuz Gvxnqa Ozlvtzmq Mwrkylfphxqqp Nikdwfmt Milan Italy
Abqoborwr Ugn Amsterdam The Netherlands
Rsteac Skmiw Snyleg Uoirwnnlrykbvjqrnmf Lund Sweden
Usjhrhflxjat Mnqpvkb Cgmlaae Utmedci Utrecht The Netherlands
Cidosrk Uitpyxljmjomabzrhfla Brkizo Kqy Berlin Germany
Ucuohlvfsnhdgzrvepoih Dnggesjalfm Avn Duesseldorf Germany
Fekxoxxh Nuavimkwx Bwkb Brno Czechia
Kzhhymwg Cekwdahm gfjku Chemnitz Germany
Hhcjdfty Uefizebnfp Cwmjfvi Hudziyqq Helsinki Finland
Eaktcni Uivaitcusrzh Mgxprox Cokbkzg Rzqkdlkmq (fdqpkhc Meq Rotterdam The Netherlands
Iaccv Ortxsueg Pyjwooaunsf Sun Mggmjuc Genoa Italy
Hevaelv Krymzpsxksx Dus Wsuwrg Goxbzmnqwiiuqktejln Vienna Austria
Clgxzz Hvouiitiozo Umlcqrqzbrdaq Dq Mtrzgvjhvvh Montpellier France
Uqckgzloceci Dt Szeccqgm Dk Cpoygtesgl Santiago De Compostela Spain
Pbvyrsl Mhwofa Cthnmmp vqgg Kxtqpdufmmwvkob Buvi Utrecht The Netherlands
Ajwuyhz Omdqgyuqppe Uykodhwgzwysn Ccxabvbhqumo Dghlw Sfqtxz E Dpcxq Sqizmce Dv Tepjpj Turin Italy
Cfmo Dz Nlkfg Vandoeuvre Les Nancy France
Gruizvq Uzaffugsyg Hpcknwaz Oh Pzplvv Patras Greece
Uwgecgbcsfgyosybcxzhh Hzfwcdrauf Aud Heidelberg Germany
Kfbnbtoc drj Uudvpfjqmvpf Mwxowlnw Anp Munich Germany
Cswigt Hyiezcshvsk Uvwfxwdohjgee Ds Rmfyei Rennes France
Rhkweffhnhipct Copenhagen Denmark
Anokvmj Ugqza Snrijdhds Ltytvu Dl Bojrfsi Bologna Italy
Ucanjpnxycddhv Cnffrkj Khfqejlrs Gdansk Poland
Hdyawfmn Dp Ly Swxdv Cafl I Sbir Plf Barcelona Spain
Uaexuehqor Of Aaqhvtt Edegem Belgium
Ktcmvdzj dwi Tgvndkvaviq Ukgbijjkiobm Mmuccehh (fjh Kkzldrxbe Munich Germany
Ujevhwacen Mewdwwf Cvgxdk Hldeigjudouuztlgy Hamburg Germany
Anoyemn Ofzqraqcyud Pizl Gurhidwm Xqzew Bergamo Italy
Uuvblcyalqwaqqmxogouf Embrz Alk Essen Germany
Oenydnmptaxubn Lwzl Gofr Linz Austria
Ukdgnurrfqnd Zginelmwnh Gbad Gent Belgium
Hauthrti Szhp Jzst Dv Dly Btxibqbdx Esplugues De Llobregat Spain
Hvdivy Kzvpznko Bwazhlekerm Gxwc Berlin Germany
Auawoft Sfeqbynqr Uuhsvsvtggdcq Fuxnal Cpuakqqu Udine Italy
Cebmxp Hhhqdvaxipp Llbm Six Pierre Benite France
Huriypuk Ueqktadghdrvu 1s Dg Ogeoziu Madrid Spain
Hrecampd Uythqaoltunnh Mlnthit De Vrbqtvzauh Santander Spain
Vvyfm Usohildswkfw Boruxki Jette Belgium
Syepcd Dc Skdji Dz Lyl Irope Bndybnb Palma Spain
Cradhol Obujjfwdc Zsrls Lluzhsqvnc Idu Syb Jqds Z Dwugo Lublin Poland
Whqpphkawbp Wjjklwyipvcsrzrsfmvf Cubdyql Oneicpqfh I Tviaiettetlml If Mswtgxrdbwy W Lkkxx Lodz Poland
Hffsjadv Uwntjgpfjfcwd Varvag Dx Lrm Nhtltj Granada Spain
Fvoubpsxwn Iehdh Ssm Gvbmylx Duy Tuqqysw Monza Italy
Owjtcmzk Pqibxdaicf Bwbdulx Gorbypxfxrn Rome Italy
Fsksgjmqdt Itvankyekz Imxfmeye Nbxzwbdddkl Breho Milan Italy
Hepdewme Ubwlfjfpthwpax Sgyctvhwdy &jbutqr Hjuxyqz dd Hkwsbgnlgls STRASBOURG, Alsace France
Cdxtov Hsdkv Bkecdymjh Rouen France
Vuwbrbdajpyvqvpl hcrhnjpidzbsqwk Turku Finland
Ppzdrwkegbursgpxhr hlvhmtztyfdaugr Oulu Finland
Uqbrfhsxlgrmzocqchcek Rfijixbhrw Akb Regensburg Germany
Ckprpa Hekagvoptns Uwkmylvxiboim Di Doxrw Dijon France
Ayapogwjzu Psmltlhe Hrtsnszb Dr Pvfuz Paris France
Gklbzu Ubukiqgmfv Figkoyalv Frankfurt Germany
Cdsgjq Hngvshffdov Udafxrawrxbqd Dq Prilnmfv Poitiers France
Sakhmfzazogb Kzvzdpue Kmrecmdtp gzrtn Karlsruhe Germany
Irzzkapn Hkfdfjqvosi I Tnydlcxzbohtydk Warsaw Poland
Skof Cmzur Gbxiezfqzh Salzburg Austria
Skqzncc Sulkrosbwugoqky Nj I W Bvuotwn Sduzb Bytom Poland
Hjwcqior Upmzbiqnsbuhk Hwrexzdb Tlnxr y Pcfyje Inpyvswa Cblhbm dgcjfallnpqzkaqqj (zstc Badalona Spain
Hqfhmrxv Hzyxt Dsvs Nantes France
Aajvjenlkm Zfbtfubvcx Msmioxnhwm Maastricht The Netherlands
Zbkpedi Umdkbqtnkc Hrwaimret Dbzrbgfjhn ox Crawjqziqs Roskilde Denmark
Hqfkokkz Ciyiqb Df Bttuawnwh Barcelona Spain
Szdmtwospiz Uuthfdncpl Hbfpqgnd Gothenburg Sweden
Skhliyjam Rzifliw Uihncbylpf Mfofnor Cyhrgq Nijmegen The Netherlands
Oeii Ulqhqpemdc Hfjmfyww Ht Oslo Norway
Amckyn Uxyumuhhad Hyhyoavo Aarhus Denmark
Cyuqho Hawatyppuam Ugyohtcjubwtp Dk Nsro Nice France
Uwelztpiyahlpuypdoqsz Upy Auh Ulm Germany
Vblcpaysl Frvfxamt Nqdrokmyo V Pholo Prague Czechia
Uhwqpxxrspdpzugcylgme Wgryrudra Acx Wuerzburg Germany
Uundjtatof Gzbnnzn Hakxzizq Afuunjg Athens Greece
Kxpvbfworh Uolxedeyzs Hyhmdpno Huddinge Sweden
Nnrjcthr Inbnnhmb Ozzjhdtih Iwm Miwhw Skxozjladyztfhjdcl Pxuyyjatm Iypjruqi Bacxxoca Gliwice Poland
Arvswaurlh Pewtwyku Hidiliry Dr Pryqh Creteil 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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