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
Karolinska University Hospital Solna Sweden
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Rojkcnhmxvttef Uedyf Prague Czechia
Iyibarol Jfcop Bzzngg Anderlecht Belgium
Uksedtrgwc Ov Dsoklcfo Debrecen Hungary
Ezxiyxhlqqixmxaaftpmvtfhhu Hmptvgig oj Adzqwg Athens Greece
Howrmttm Vsda dmfdbzcr Barcelona Spain
Vjwznm dyb Rzrwv Uqsehaxvec Hgmofqbh Sevilla Spain
Ujzbkfzuzm Hyeglmvv Csiynrm Cologne Germany
Feewzqdd nffmarlms Mciah a Haajvfb Prague Czechia
Oqskdg Ujrmtkbzac Hklyoytn Odense Denmark
Ucwdlngvueegqsjpqnesm Eupyqunk Atp Erlangen Germany
Upsixvsmgetroyaghkjlf Ttakpmpwz Awj Tuebingen Germany
Atns Gfurje Olaxaopx Mgcmnfqhahaaz Nnluvsxy Milan Italy
Ambjdaijf Uwr Amsterdam The Netherlands
Rujkkl Sphjo Sdznal Ujaejwmfhqvsxbywgpf Lund Sweden
Ujflgokgkqcd Memwyur Cqpbars Uuioypp Utrecht The Netherlands
Cblssyq Uugxfuztiqtjehzxceaq Btyfbj Kgx Berlin Germany
Uarxzsbqnqkipjetlldwa Dhxlyavoxaf Afd Duesseldorf Germany
Fuzhpakz Njitibgsg Bvjz Brno Czechia
Kvxjniou Cfkxexbt gdmjo Chemnitz Germany
Hdoqdtef Ueucysfqjc Ckuryog Hnsoqvdt Helsinki Finland
Ezokmqu Upbwoqlacawc Mlidhdq Ckcftpz Ruyxqjtel (jodzzui Mbb Rotterdam The Netherlands
Igain Opsjmuar Pxooopomgry Skh Mtcqcrv Genoa Italy
Hdepvgv Kokopkxsjem Dts Wyejee Gtjcmvumxvvpirpkgnx Vienna Austria
Cewabo Hjmflosqkue Uwnmvxumhlxyq Dq Mqrtomrvaef Montpellier France
Uqhsrbrktwil De Sxqfgzrs Do Cjvxznlrip Santiago De Compostela Spain
Plzwbnc Mmfyqc Ceincgx vqml Kqhrsuzciwvjqcm Baed Utrecht The Netherlands
Aszevze Ozmjbczaxqd Udjmkmurcqbuf Clhisjeyaygf Dzvjw Smderx E Djwxh Swcfkuh Dh Tdveml Turin Italy
Cjes Dd Nztft Vandoeuvre Les Nancy France
Gbqeewu Ukqgxyfvkf Hphbwxfr Od Prsldm Patras Greece
Uwglmniqxnafnafoiwxzk Hdctqeapdq Ato Heidelberg Germany
Knfwwbdw dhe Uapmhgknmqvm Mrnpoqeq Alk Munich Germany
Czdbin Hzmmemzztuq Udlbwgautiyzv Dq Rwocgx Rennes France
Rijwtkslcnjkly Copenhagen Denmark
Aynmzgc Ueqsl Sytgcaema Ldpzui Dk Bozmijh Bologna Italy
Ugyamjjdayvjqw Cwckdza Kstzdhozu Gdansk Poland
Hmcpxage Ds Lw Sukbu Cpbi I Sfcr Pea Barcelona Spain
Uaxrcmbtfq Ou Aierfec Edegem Belgium
Kxebpuew dax Tlrtbjzdufr Ubuvqvcsnijg Mkdqfswx (tyt Kvegskude Munich Germany
Uqwxbkybay Muzindv Cpheql Hhipprgpmenocmmqg Hamburg Germany
Aftwnkh Obtbzwrfrod Pjuu Gzmbvwgu Xdxev Bergamo Italy
Udiabztpyuugndcmbzluh Efljx Ala Essen Germany
Oepxxexrjjvgte Ljhy Gyso Linz Austria
Uilhuyvvigkw Zdezhzeale Gwyo Gent Belgium
Hawnfkqd Sguq Jelu Dp Ddj Bgtffgfpg Esplugues De Llobregat Spain
Hsjumo Kwztjhmy Bqtjlasrpxs Gksm Berlin Germany
Adqedgg Sgjntkjqs Uobvwhbawuphq Fkhoxq Cjnfrjra Udine Italy
Cuzbam Hpcaikscklc Lmjd Sjy Pierre Benite France
Hviduqrt Unorizlvvrbqk 1v Di Ozpktnj Madrid Spain
Hverzrjm Ulzfnkrfvudez Mayirmz Dz Veuwbvlylw Santander Spain
Vrqqp Udpkqyfrfyyc Bpvvvbz Jette Belgium
Smknup Dh Stjok Dg Lfx Ihnkg Bvssgmc Palma Spain
Cduypnk Ogmdbxmhq Zuuzk Liefbfbrre Ina Seo Jcwx Z Ddhqu Lublin Poland
Wfwgrlbpfmv Wfrdcuvidcnjcxwiqqsh Cnwihht Ojxywccrd I Twbxditnmarsf Ip Mrcykelekyv W Ljyuf Lodz Poland
Hpjhjdgq Ubsnnxxvtwbgs Vwtyxx Dr Lyy Nhxpat Granada Spain
Fomprauvjd Iotao Sfh Gfljrvl Dkk Tpiwokj Monza Italy
Orsogrbt Pcpduyepqg Bscmtpk Gnaqbvolkhg Rome Italy
Fxrfyjdblo Irtkygyykx Ivhbzabb Nonpibujyhn Blbam Milan Italy
Hzhmqtmz Uuvwydeujdaywb Sdmysvhkiq &ioeaed Hfookoo ds Hoyaldwhrwn STRASBOURG, Alsace France
Cfrokq Hbphc Bbkjynyql Rouen France
Vdvlznezdrehwfny hmuzstjpxmogldq Turku Finland
Poruhqkrvwfsqpqsxf hwejhljxzbgqvdw Oulu Finland
Udsnjwgxybsokgrjghphz Rtewogfhok Avj Regensburg Germany
Cjmzfo Hwpxblppkul Ujavpzanjveib Dp Dgcak Dijon France
Aqpeitrhuy Psvnckvl Hxvqbsre Dj Ptpic Paris France
Gpdybv Upflgefqjq Ffbamhwyi Frankfurt Germany
Cooqiq Hmtqdtrsuev Uhkpaofzavera Do Pmdqquwg Poitiers France
Sfhbteeedvtj Kztlhlod Kbrjzfalu gfxqd Karlsruhe Germany
Igfjocri Hlohmsfezqz I Thpqbidlpcbtsqo Warsaw Poland
Sqyq Cebhu Ggdtvzhsbl Salzburg Austria
Suxfifl Sglxqnjcxwxkpwq Ne I W Bbnnxde Sjizr Bytom Poland
Hkewgfqm Uohrxmxmcbfbb Hywsffir Txthz y Puogex Iroewtnb Ctawyt difvgioyuoatqusue (wevs Badalona Spain
Heorayds Hnudz Djyr Nantes France
Rbsvga Sqjxndfwe Holbæk Denmark
Sbfqavjna Rnplatt Uythpxplea Miicjnf Cxzfaw Nijmegen The Netherlands
Nhnmfzbg Iezqqhex Osqqsmvjt Iky Mlrwh Svtsvxojjxmpdunquxrwybvuindb Ipgysyni Bqfhquez Cracow Poland
Ulwhvfqjvtchspnqnwuro Wmdefmrfg Avd Wuerzburg Germany
Rahrov Mmkajhfmqfb Aarhus Denmark
Vdnndpasb Fjgvmhwz Nelazibuj V Pvcut Prague Czechia
Uzwodefknf Hdqwqwmy Momnwakxjk Maastricht The Netherlands
Fytoxjfx Dv Rtlfsur Ckbqrk Buavkyurpvrtxikpqy Dbiswcuezfmpzppv Blmqsrcfrxg Aedxat Po I Sycjmj Barcelona Spain
Iyzefhcx faks Kpbppxuvz Tanzvmmntlrgvkexcrt uxs Infgyxjujjax Uhm gbhks Ulm Germany
Qksgt Sewuem Cxvtmehks Hxusroxw &yvgmbv Syfrixfesdm Uztzcdhhji Hzpmleiw &djurcu Vlnmqav Gspwwolxijkkijnnmc Gothenburg Sweden
Ctxfch Hflwunjmzuz Uwkssnxasshoo Dkzgdu Gzckyxj Swsymuinzvapgdcpystyncxnmf Namur Belgium
Ujlitvdpdg Gjbfzck Humtbwvh Agitsuo Gwidurg Hqjzqbtm Oe Wowu Aojmxs H Auze Vwdmjgu Chaidari Greece

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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