AzTrials
AzTrials

NeoplasmsPhase 2/3NCT03435796

Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

A Phase 2/3 study testing Gene-modified (GM) T cell therapy in people with Neoplasms, run by Celgene at 225 sites in 23 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Read more about this study

Who is it for?
Any age
Conditions the study is for
Neoplasms
What is being tested?
Gene-modified (GM) T cell therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,541 participants
Where
225 sitesin 23 countries
Study dates
19 Jul 2018to 29 May 2043
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
  • Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.

Who cannot join

  • Not Applicable
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

225 sites in 23 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

225 sites in 23 countries

United States104 sites, 78 recruiting

  • New York Oncology Hematology P.C.

    Albany, New York, 12206

    Courtney Bellomo, Site 01041

    Recruiting

  • University Of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

    Monalisa Ghosh, Site 01024, 734-936-4000

    Recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

    Sagar Lonial, Site 01103, 404-778-1900

    Recruiting

  • Northside Hospital, Inc

    Atlanta, Georgia, 30342

    Scott Solomon, Site 01207, 404-255-1930

    Recruiting

  • University Of Colorado Cancer Center

    Aurora, Colorado, 80045

    Manali Kamdar, Site 01208, 720-848-0752

    Recruiting

  • University of Maryland - Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

    Mehmet Kocoglu, Site 01164, 501-526-6990

    Recruiting

  • Sidney Kimmel Comp Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

    Syed Abbas Ali, Site 01017, 443-287-7104

    Recruiting

  • Local Institution - 01114

    Bethesda, Maryland, 20892-1203

    Completed

  • University of Alabama Birmingham

    Birmingham, Alabama, 10016

    Luciano Costa, Site 01171, 205-934-9695

    Recruiting

  • Local Institution - 01107

    Boston, Massachusetts, 02114

    Withdrawn

  • Massachusetts General Hospital / Dana-Farber Cancer Institute

    Boston, Massachusetts, 02114

    Jeremy Abramson, Site 01012, 617-571-3037

    Recruiting

  • Local Institution - 01106

    Boston, Massachusetts, 02115

    Withdrawn

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Francisco Hernandez-Ilizaliturri, Site 01111, 716-845-3099

    Recruiting

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Saira Sheikh, Site 01071, 919-966-0545

    Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Bei Hu, Site 01204, 980-442-5231

    Recruiting

  • University Of Virginia Health System

    Charlottesville, Virginia, 22903

    Indumathy Varadarajan, Site 01065, 434-924-9333

    Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Reem Karmali, Site 01014, 312-695-0990

    Recruiting

  • University Of Chicago Medical Center

    Chicago, Illinois, 60637-1447

    Peter Riedell, Site 01018, 773-702-8412

    Recruiting

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

    James Essell, Site 01037, 513-686-5482

    Recruiting

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106-5000

    Leland Metheny, Site 01042, 216-844-0139

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Brian Hill, Site 01062, 216-445-9451

    Recruiting

  • Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

    Srinivas Devarakonda, Site 01074, 570-423-0522

    Recruiting

  • Texas Oncology

    Dallas, Texas, 75230

    Jay Courtright, Site 01044, 972-566-4291

    Recruiting

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

    Houston Holmes, Site 01180, 214-584-3402

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Larry Anderson, Site 01104, 214-648-5906

    Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Tara Gregory, Site 01212, 720-754-4800

    Recruiting

  • Karmanos Cancer Center Wayne State University

    Detroit, Michigan, 48201

    Abhinav Deol, Site 01025, 313-576-8093

    Recruiting

  • City Of Hope

    Duarte, California, 91010

    Tanya Siddiqi, Site 01011, 626-256-4673

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27705

    Taewoong Choi, Site 01175

    Recruiting

  • Local Institution - 01030

    East Brunswick, New Jersey, 08816

    Completed

  • Willamette Valley Cancer Institute

    Eugene, Oregon, 97401

    Jeff Sharman, Site 01052, 541-683-5001

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Rajneesh Nath, Site 01049, 480-256-3223

    Recruiting

  • Hematology and Oncology Associates of SC, LLC

    Greenville, South Carolina, 29615

    Saeeda Chowdhury, Site 01034, 864-241-6252

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    David Siegel, Site 01102, 201-996-5900

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Maureen Mayes, Site 01215, 713-500-6905

    Recruiting

  • University of Texas- MD Anderson

    Houston, Texas, 77030

    Hun Lee, Site 01013, 713-794-1829

    Recruiting

  • IN Univ Simon Cancer Center

    Indianapolis, Indiana, 46202

    Rafat Abonour, Site 01161, 317-690-1577

    Recruiting

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

    Anand Tandra, Site 01217, 317-871-0000

    Recruiting

  • Local Institution - 01020

    Indianapolis, Indiana, 46237

    Completed

  • The Mayo Clinic - Jacksonville, Davis-E

    Jacksonville, Florida, 32224

    Sikander Ailawadhi, Site 01201, 904-953-0853

    Recruiting

  • University Of California San Diego Moores Cancer Center

    La Jolla, California, 92093

    Thomas Kipps, Site 01019, 858-822-6135

    Recruiting

  • University Of Kentucky

    Lexington, Kentucky, 40536

    Chaitanya Iragavarapu, Site 01046

    Recruiting

  • Local Institution - 01206

    Los Angeles, California, 90048

    Withdrawn

  • Norton Cancer Institute Louisville Oncology

    Louisville, Kentucky, 40207

    Don Stevens, Site 01032, 502-899-3366

    Recruiting

  • University Of Wisconsin

    Madison, Wisconsin, 53705

    Natalie Callander, Site 01036, 082658690

    Recruiting

  • Local Institution - 01040

    Maywood, Illinois, 60153

    Withdrawn

  • Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics

    Miami, Florida, 33136

    Lazaros Lekakis, Site 01214, 305-748-0641

    Recruiting

  • Baptist Cancer Center

    Miami, Florida, 33176

    Yuliya Linhares, Site 01047, 786-596-2000

    Recruiting

  • Froedtert Hospital BMT Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Othman Akhtar, Site 01178

    Recruiting

  • M Health Fairview University of Minnesota Medical Center - East Bank

    Minneapolis, Minnesota, 55455

    Veronika Bachanova, Site 01112, 612-625-5469

    Recruiting

  • Morristown Memorial Hosp

    Morristown, New Jersey, 07962

    Mohamad Cherry, Site 01027, 973-971-7906

    Recruiting

  • Sarah Cannon Research Inst

    Nashville, Tennessee, 37203

    Jesus Berdeja, Site 01101, 615-329-0570

    Recruiting

  • Local Institution - 01053

    New Brunswick, New Jersey, 08903

    Withdrawn

  • Yale Cancer Center

    New Haven, Connecticut, 06520

    Iris Isufi, Site 01059, 203-688-4242

    Recruiting

  • Local Institution - 01026

    New Orleans, Louisiana, 70112

    Withdrawn

  • Local Institution - 01066

    New York, New York, 10016

    Withdrawn

  • New York University - Langone Medical Center - The Center for Musculoskeletal Care

    New York, New York, 10016

    Amit Saxena, Site 01070, 646-501-7400

    Recruiting

  • Weill Cornell Medicine / New York Presbyterian Hospital

    New York, New York, 10021

    Roger Niles Pearse, Site 01198, 212-746-2956

    Recruiting

  • Icahn School Of Medicine At Mount Sinai

    New York, New York, 10029

    Sundar Jagannath, Site 01109, 212-241-7873

    Recruiting

  • Columbia University Medical Center/New York-Presbyterian Hospital

    New York, New York, 10032

    Ran Reshef, Site 01209, 212-342-0530

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Maria Palomba, Site 01177, 212-639-7186

    Recruiting

  • Local Institution - 01063

    Niles, Illinois, 60714

    Withdrawn

  • Local Institution - 01045

    Norfolk, Virginia, 23502

    Completed

  • University of Massachusetts Memorial Medical Center

    North Worcester, Massachusetts, 01655

    Poorva Bindal, Site 01213, 774-442-3903

    Recruiting

  • University of Oklahoma Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

    Adam Asch, Site 01038, 405-271-4022

    Recruiting

  • University Of Nebraska Medical Center

    Omaha, Nebraska, 68198-6840

    Matthew Lunning, Site 01015, 402-559-7164

    Recruiting

  • Local Institution - 01035

    Orlando, Florida, 32804

    Completed

  • Local Institution - 01061

    Philadelphia, Pennsylvania, 19104

    Completed

  • University of Pennsylvania Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

    Stephen Schuster, Site 01016, 215-614-1846

    Recruiting

  • Thomas Jefferson University - Clinical Research Institute

    Philadelphia, Pennsylvania, 19107

    Xia Bi, Site 01173, 302-220-7456

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Asya Varshavsky-Yanovsky, Site 01172

    Recruiting

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85054

    Jeremy Larsen, Site 01200

    Recruiting

  • UPMC Cancer Pavillion

    Pittsburgh, Pennsylvania, 15232

    Alison Sehgal, Site 01210, 412-648-6579

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Stacy Lewis, Site 01028, 503-215-5696

    Recruiting

  • Oregon Health and Science University OHSU

    Portland, Oregon, 97239

    Richard Maziarz, Site 01022, 503-231-2498

    Recruiting

  • Local Institution - 01023

    Richmond, Virginia, 23298

    Withdrawn

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Yi Lin, Site 01105

    Recruiting

  • Local Institution - 01051

    Rochester, New York, 14642

    Withdrawn

  • Local Institution - 01043

    Sacramento, California, 95816

    Withdrawn

  • Novant Health

    Salisbury, North Carolina, 28147

    Alan Skarbnik, Site 01058, 347-266-6406

    Recruiting

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Douglas Sborov, Site 01199, 801-585-0255

    Recruiting

  • Intermountain Healthcare - LDS Hospital

    Salt Lake City, Utah, 84143

    Dannish Hoda, Site 01029

    Recruiting

  • Sam Clinical Research Center

    San Antonio, Texas, 78229

    Paul Shaughnessy, Site 01211, 210-670-2313

    Recruiting

  • University of California, San Francisco- California

    San Francisco, California, 94143

    Charalambos Andreadis, Site 01108, 415-238-1909

    Recruiting

  • UCLA Medical Centre-Santa Monica

    Santa Monica, California, 90095

    Sarah Larson, Site 01184, 310-829-5471

    Recruiting

  • Local Institution - 01039

    Scottsdale, Arizona, 85258

    Completed

  • Local Institution - 01257

    Seattle, Washington, 98104

    Site 01257

    Not yet recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Daniel Egan, Site 01166, 617-699-2437

    Recruiting

  • Local Institution - 01060

    Seattle, Washington, 98105

    Withdrawn

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Jordan Gauthier, Site 01110, 206-667-2713

    Recruiting

  • Local Institution - 01064

    Sioux Falls, South Dakota, 57105

    Withdrawn

  • Local Institution - 01056

    Southfield, Michigan, 48075

    Completed

  • Siteman Cancer Center

    St Louis, Missouri, 63110

    Ravi Vij, Site 01176, 314-409-4144

    Recruiting

  • Stanford Cancer Center

    Stanford, California, 94305

    Michaela Liedtke, Site 01119, 650-498-6000

    Recruiting

  • Local Institution - 01055

    Tacoma, Washington, 98405

    Withdrawn

  • USF Health Morsani Center for Advanced Healthcare

    Tampa, Florida, 33606

    Loutfi Succari, Site 01247, 813-974-2681

    Recruiting

  • H. Lee Moffitt Cancer Center and Research Institute University of South Florida

    Tampa, Florida, 33612

    Melissa Alsina, Site 01153, 813-745-7202

    Recruiting

  • Local Institution - 01033

    Temple, Texas, 76508

    Withdrawn

  • Local Institution - 01021

    Tucson, Arizona, 85724

    Withdrawn

  • Local Institution - 01054

    Tyler, Texas, 75702

    Completed

  • Local Institution - 01050

    Washington D.C., District of Columbia, 20007

    Withdrawn

  • Local Institution - 01069

    Wauwatosa, Wisconsin, 53226

    Site 01069

    Not yet recruiting

  • Kansas University Medical Center

    Westwood, Kansas, 66205

    Al-Ola Abdallah, Site 01174, 918-261-6196

    Recruiting

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

    Bassam Mattar, Site 01031, 316-262-4467

    Recruiting

Other trials in United States

France18 sites, 14 recruiting

  • Hopital Henri Mondor

    Creteil-Paris, 94000

    Karim BELHADJ-MERZOUG, Site 09211, +33149812163

    Recruiting

  • CHRU de Lille France

    Lille, 59037

    Ibrahim YAKOUB-AGHA, Site 09202, +33320445551

    Recruiting

  • Local Institution - 09601

    Lyon, 69008

    Withdrawn

  • Local Institution - 09400

    Marseille, 13009

    Completed

  • Local Institution - 09602

    Marseille, 13385

    Withdrawn

  • Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve

    Montpellier, 34295

    Jacques Morel, Site 09008, 33467338710

    Recruiting

  • CHU Montpellier - Hôpital Saint Eloi

    Montpellier, 34295

    Guillaume Cartron, Site 09206, +33675926918

    Recruiting

  • Chu Hotel Dieu

    Nantes, 44093

    Philippe Moreau, Site 09401, 33240083271

    Recruiting

  • Hopital Saint Louis

    Paris, 75010

    Bertrand Arnulf, Site 09204, 33142499472

    Recruiting

  • Hôpitaux Universitaires Pitie Salpêtrière Charles Foix

    Paris, 75013

    Celine Louapre, Site 09001, 33142165766

    Recruiting

  • Hospital Saint Louis

    Paris, 75475

    Catherine Thieblemont, Site 09207, 33142499236

    Recruiting

  • Local Institution - 09600

    Paris, 75935

    Withdrawn

  • Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Haut-Leveque

    Pessac, 33600

    Cyrille Hulin, Site 09210, 33557656511

    Recruiting

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

    Herve Ghesquieres, Site 09201, 33478864348

    Recruiting

  • CHU La Miletrie

    Poitiers, 86021

    xavier leleu, Site 09203, +33 982602178

    Recruiting

  • Hopital Sud

    Rennes, 35000

    Alain Lescoat, Site 09212, 33299284321

    Recruiting

  • Institut Universitaire du Cancer de Toulouse - Oncopole

    Toulouse, 31059

    Aurore Perrot, Site 09205, 0531156184

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Vincent Ribrag, Site 09402, 33142114507

    Recruiting

Other trials in France

Germany17 sites, 13 recruiting

  • Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

    Berlin, 10117

    David Simon, Site 03156, +49(0)9131-85-43253

    Recruiting

  • Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. Tumorimmuno

    Berlin, 13125

    Bertram Glass, Site 03451, +49 30 94 01-12101

    Recruiting

  • Local Institution - 03155

    Berlin, 13353

    Site 03155

    Not yet recruiting

  • Kinikum der Universitaeat zu Koeln

    Cologne, 50937

    Peter Borchmann, Site 03151, 4922147898888

    Recruiting

  • Universitatsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, D-01307

    Martin Wermke, Site 03152, +49 351 458-7566

    Recruiting

  • Local Institution - 03513

    Düsseldorf, 40225

    Withdrawn

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

    Joerg Distler, Site 03161, 00492118117817

    Recruiting

  • Universitaetsklinikum Essen

    Essen, 45147

    Refik Pul, Site 03004, 4920172382382

    Recruiting

  • Local Institution - 03500

    Frankfurt, 60590

    Withdrawn

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20426

    Francis Ayuk, Site 03452

    Recruiting

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120

    Marc-Steffen Raab, Site 03502, 496221565427

    Recruiting

  • Otto-von-Guericke-Universitaet Magdeburg - Universitaetsklinikum Magdeburg A.Oe.R - Universitaetskli

    Magdeburg, 39120

    Dimitrios Mougiakakos, Site 03009, 49-391-67-21233

    Recruiting

  • LMU Klinikum der Universität

    München, 81377

    Marion Subklewe, Site 03154, +49 89 4400-73133

    Recruiting

  • Local Institution - 03454

    Münster, 48149

    Withdrawn

  • Local Institution - 03503

    Tübingen, 72076

    Completed

  • University Hospital of Ulm

    Ulm, 89081

    Andreas Viardot, Site 03153, +49-73150045539

    Recruiting

  • Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II

    Würzburg, 97080

    Hermann Einsele, Site 03501, +4994120140202

    Recruiting

Other trials in Germany

Japan16 sites, 14 recruiting

  • Local Institution - 13202

    Bunkyō City, 113-8677

    Completed

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

    Emiko Sakaida, Site 13603, 81-43-222-7171

    Recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 1040045

    Koji Izutsu, Site 13601, 81 335422511

    Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582

    Koji Kato, Site 13805, 81-92-642-5155

    Recruiting

  • Tokai University Hospital

    Isehara City, Kanagawa, 259-1193

    Yoshiaki Ogawa, Site 13803, 8181463931121

    Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

    Junya Kuroda, Site 13001, 81752515740

    Recruiting

  • Toranomon Hospital

    Minato-ku, Tokyo, 105-8470

    Go Yamamoto, Site 13602, 81335881111

    Recruiting

  • Nagoya City University Hospital

    Nagoya, 467-8602

    Shinsuke Iida, Site 13807, 81528515511

    Recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

    YASUHISA Sando, Site 13004, 81862949911

    Recruiting

  • Osaka Metropolitan university Hospital

    Osaka, 545-8586

    Yasuhiro Nakashima, Site 13203, 81666452121

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 0608648

    Hideki Goto, Site 13806, 81117067214

    Recruiting

  • Japan Red Cross Medical Center

    Shibuya-ku, 150-8935

    Tadao Ishida, Site 13801, 8133400104

    Recruiting

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498

    Yoshinobu Kanda, Site 13802, +81-285-58-7195

    Recruiting

  • Local Institution - 13804

    Shinjuku, 162-8666

    Withdrawn

  • Osaka Red Cross Hospital

    Tennoji-Ku, Osaka, 543-8555

    Kazunori Imada, Site 13003, 81-6-6774-5111

    Recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585

    Satoshi Ito, Site 13006, 0000000000

    Recruiting

Other trials in Japan

Spain12 sites, 11 recruiting

  • Hospital Universitario Vall D hebron

    Barcelona, 08035

    Pere Barba Suñol, Site 08451, 349348930004897

    Recruiting

  • Hospital Universitari Germans Trias i Pujol ICO Badalona

    Barcelona, 08916

    Albert Oriol Rocafiguera, Site 08702, 34934978987

    Recruiting

  • Institut Clinic de Nefrologia i Urologia - Hospital Clinic i Provincial de Barcelona

    Barcelona, 8036

    Armando Lopez Guillermo, Site 08600, +34932275475

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

    Alejandro Escudero Contreras, Site 08708

    Recruiting

  • Local Institution - 08251

    Esplugues de Llobregat, 08950

    Completed

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009

    Alba Rubio, Site 08252, 34915035900

    Recruiting

  • Hospital 12 De Octubre

    Madrid, 28041

    Joaquin Martinez Lopez, Site 08601, 34913908525

    Recruiting

  • Hospital Regional Universitario de Malaga (Antiguo Carlos Haya)

    Málaga, 29010

    Antonio Fernandez Nebro, Site 08705, +34951290360

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona, 31008

    Paula Rodriguez Otero, Site 08701, +0034948254000 0 000

    Recruiting

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007

    Maria Victoria Mateos Manteca, Site 08751, 34923291100

    Recruiting

  • Instituto De Investigacion Marques De Valdecilla (IDIVAL)

    Santander, 39008

    Ricardo Blanco Alonso, Site 08707

    Recruiting

  • Hospital Virgen Del Rocio

    Seville, 41013

    Delgado Javier, Site 08253, +955013077

    Recruiting

Other trials in Spain

Italy11 sites, 9 recruiting

  • Ospedali Riuniti di Ancona

    Ancona, 60126

    Federico Lussana, Site 07602

    Recruiting

  • Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi

    Bologna, 40138

    Michele Cavo, Site 07601, +390516363680

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Paolo Corradini, Site 07402, +00390223903146 0000

    Recruiting

  • Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM)

    Monza, 20900

    Adriana Balduzzi, Site 07301

    Recruiting

  • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

    Naples, 80131

    Antonio Pinto, Site 07303, 390815903382

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Roma, 00168

    MARIA ANTONIETTA D'AGOSTINO, Site 07306, +393495458711

    Recruiting

  • Local Institution - 07500

    Roma, 00168

    Withdrawn

  • Ospedale Pediatrico Bambino Gesu

    Rome, 00165

    Franco Locatelli, Site 07300, 390668593697

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

    Armando Santoro, Site 07501, +00390282244080 0000

    Recruiting

  • Local Institution - 07610

    Torino, 01012

    Completed

  • Azienda Sanitaria Ospedaliera San Giovanni Battista Molinette

    Turin, 10126

    Barbara Botto, Site 07401, 3479131037

    Recruiting

Other trials in Italy

Belgium6 sites, 4 recruiting

  • Jules Bordet Institut

    Anderlecht, 1070

    Marie Vercruyssen, Site 05202, 02 5413847

    Recruiting

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

    Ann De Becker, Site 05203, 0000000000

    Recruiting

  • Local Institution - 05200

    Ghent, 9000

    Withdrawn

  • Uz Gent

    Ghent, 9000

    Fritz Offner, Site 05351, +32(0)93328770

    Recruiting

  • University Hospital Leuven

    Leuven, 3000

    Michel Delforge, Site 05201, +3216346880

    Recruiting

  • Local Institution - UNK 2

    Leuven, B-3000

    Withdrawn

Other trials in Belgium

Canada5 sites, 3 recruiting

  • University Of Calgary

    Calgary, Alberta, T2N 2T9

    Nizar Bahlis, Site 02302, 4039441880

    Recruiting

  • Local Institution - 02801

    Hamilton, Ontario, L8V 1C3

    Withdrawn

  • CIUSSS de l'Est-de-l'Ile-de-Montreal

    Montreal, Quebec, H1T 2M4

    Luigina Mollica, Site 02800

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Christine Chen, Site 02301, 4169464501

    Recruiting

  • Local Institution - 02802

    Vancouver, British Columbia, V5Z 1M9

    Withdrawn

Other trials in Canada

United Kingdom5 sites, 4 recruiting

  • Local Institution - 10850

    Leeds, LS9 7TF

    Withdrawn

  • Kings College Hospital

    London, SE5 9RS

    Reuben BEnjamin, Site 10851, 02032991248

    Recruiting

  • UCL Cancer Institute

    London, WC1E 6BT

    Claire Roddie, Site 10501, +4402034479911 (0)

    Recruiting

  • Christie Hospital Nhs Trust

    Manchester Withington, M20 4BX

    Kim Linton, Site 10502, 0161 918 7227

    Recruiting

  • Somers Cancer Research Building

    Shirley Southampton, SO16 6YD

    Andrew Davies, Site 10500, +442380795246 00 00

    Recruiting

Other trials in United Kingdom

Australia4 sites, 4 recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

    Phoebe Joy Ho, Site 16003

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

    Simon Harrison, Site 16001, +61424189068

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Shafqat Inam, Site 16004, 0472591197

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

    Stephanie Lam, Site 16006, +61861523788

    Recruiting

Other trials in Australia

Israel4 sites, 4 recruiting

  • Soroka Medical Center

    Beersheba, Southern District, 85025

    Uri Greenbaum, Site 18006, +972584046264

    Recruiting

  • Hadassah Medical Center - Ein Kerem Hospital

    Jerusalem, 9112001

    Eyal Lebel, Site 18002, 972-50-5172304

    Recruiting

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906

    Ron Ram, Site 18005, 97236974138

    Recruiting

  • The Chaim Sheba Medical Center

    Tel HaShomer, 5262100

    Hila Magen, Site 18003, 972504065462

    Recruiting

Other trials in Israel

South Korea4 sites, 4 recruiting

  • Seoul National University Hospital

    Seoul, 03080

    YOUNGIL KOH, Site 17006, 01091175012

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Kihyun Kim, Site 17001, +821099333456

    Recruiting

  • Asan Medical Center (AMC)

    Seoul, 5505

    Dok Hyun Yoon, Site 17003, 82230105940

    Recruiting

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 6591

    Chang Ki Min, Site 17002, 82-20-2258-6053

    Recruiting

Other trials in South Korea

Denmark3 sites, 3 recruiting

  • Local Institution - 20003

    Aarhus, 8200

    Site 20003

    Not yet recruiting

  • Odense University Hospital

    Odense, 5000

    Thomas Stauffer Larsen, Site 20001, +4565414855

    Recruiting

  • Roskilde Sygehus

    Roskilde, Region Sjælland, 4000

    Nicolai Jorgensen, Site 20005

    Recruiting

Other trials in Denmark

Netherlands3 sites, 1 recruiting

  • Local Institution - 04650

    Amsterdam, 1081 HV

    Completed

  • Erasmus Medical Center - Daniel den Hoed

    Rotterdam, 3075 EA

    Pim Mutsaers, Site 04301

    Recruiting

  • Local Institution - 04400

    Utrecht, 3584 CS

    Withdrawn

Other trials in Netherlands

Poland3 sites, 3 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

    Jan Zaucha, Site 22006, +48585844340

    Recruiting

  • St Johns Cancer Centre in Lublin

    Lublin, 20-090

    Wojciech Legiec, Site 22004, 48502074194

    Recruiting

  • Instytut Hematologii I Transfuzjologii

    Warsaw, 02-776

    Ewa Lech-Maranda, Site 22003, 48223496176

    Recruiting

Other trials in Poland

Austria2 sites, 2 recruiting

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020

    Irene Strassl, Site 12003, +004373276764411

    Recruiting

  • Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien

    Vienna, 1090

    Edit Porpaczy, Site 12101, +4314040044100

    Recruiting

Other trials in Austria

Finland2 sites, 2 recruiting

  • Helsinki University Central Hospital (HUCH)

    Helsinki, 00290

    Sirpa Leppa, Site 11551, 358504270820

    Recruiting

  • Turku University Hospital

    Turku, 20520

    Juha Ranti, Site 11002, +35823139288

    Recruiting

Other trials in Finland

Greece1 site, 1 recruiting

  • University General Hospital of Patras

    Rio Patras, 26504

    Alexandros Spyridonidis, Site 19001

    Recruiting

Other trials in Greece

Norway1 site, 1 recruiting

  • Oslo Universitetssykehus

    Oslo, 0310

    Ingerid Abrahamsen, Site 14001, +4723070460

    Recruiting

Other trials in Norway

Romania1 site, 1 recruiting

  • Institutul Clinic Fundeni

    Bucharest, 22328

    Alina Tanase, Site 23001

    Recruiting

Other trials in Romania

Sweden1 site, 1 recruiting

  • Karolinska University Hospital Huddinge

    Stockholm, 14186

    Stephan Mielke, Site 15001, 46 72 595 59 87

    Recruiting

Other trials in Sweden

Switzerland1 site, 1 recruiting

  • Inselspital Bern

    Bern, 3010

    Urban Novak, Site 06251, +41316324114

    Recruiting

Other trials in Switzerland

Turkey (Türkiye)1 site, 1 recruiting

  • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200

    Fevzi Altuntas, Site 31001, 903123360909-7215

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.

Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

Conditions
Neoplasms
Being tested
Gene-modified (GM) T cell therapy
Keywords
Long-term follow up, Gene-Modified T Cells, CAR T Cell
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gene-modified (GM) T cell therapyGenetic

    No investigational product will be administered

Study groups in NCT03435796
Study groupRoleWhat they receive
Participants exposed to Gene-modified (GM) T cell therapyOtherNot described
Receives: Genetic: Gene-modified (GM) T cell therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of delayed Adverse Events (AEs)

    Measured: Up to 15 years from last gene-modified (GM) T cell infusion

  2. Persistence of GM T cell drug products

    Measured: Up to 15 years from last GM T cell infusion

  3. Analysis of vector integration sites

    Measured: Up to 15 years from last GM T cell infusion

  4. Incidence of replication-competent lentiviruses

    Measured: Up to 15 years from last GM T cell infusion

  5. Physical growth as assessed by physical examination (pediatric participants only)

    Measured: Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached

  6. Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only)

    Measured: Up to 15 years from last GM T cells infusion or until Tanner Stage 5

  7. Proportion of participants who progressed on the study: participants with original diagnosis of malignancies

    Measured: Up to 15 years from last GM T cells infusion

  8. Overall Survival (participants with original diagnosis of malignancies)

    Measured: Up to 15 years from last GM T cells infusion

Secondary outcomes (1)

  1. Lymphocyte count (B-cell)

    If B-cell recovery criteria are not met at Month 60 (Year 5), then annual monitoring will continue up to 15 years, until subject withdrawal of consent, or death, whichever occurs first.

    Measured: Up to 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start19 Jul 2018
  3. Primary completion29 May 2043 (estimated)
  4. Study completion29 May 2043 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,541 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03435796
Sponsor's protocol ID
GC-LTFU-001
Other IDs
U1111-1206-8250, 2023-504201-36, 2023
Status last verified
Oct 2026
First submitted
9 Jan 2018
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Publications

  • Wierda WG, Dorritie KA, Gauthier J, Nath R, Kipps TJ, Riedell PA, Eradat HA, Kenderian SS, Kharfan-Dabaja MA, Shah NN, Solomon SR, Stephens DM, Ermann DA, Arnason JE, Deol A, Feldman TA, Andreadis CB, Ghosh M, Ma S, Schuster SJ, Gergis U, Vose JM, Soumerai JD, van Besien K, Tuazon SA, Perna SK, Ou SS, Ananthakrishnan R, Rane N, Papp E, Ansari S, Thompson EG, Okal A, Peiser L, Chen Y, Sengupta S, Ray PR, Wang J, Siddiqi T. Lisocabtagene maraleucel combined with ibrutinib in R/R CLL or SLL: primary results from TRANSCEND CLL 004. Blood. 2026 Jul 28:blood.2026033565. doi: 10.1182/blood.2026033565. Online ahead of print.

    PubMed 42520199

  • Abramson JS, Siddiqi T, Gordon LI, Lunning MA, Wang M, Arnason JE, Kamdar M, Maloney DG, Shadman M, Andreadis CB, Sehgal A, Solomon SR, Ghosh N, Hidalgo-Lopez JE, Wang J, Ding X, Ogasawara K, Singh A, Palomba ML. Five-year survival outcomes from TRANSCEND NHL 001 of lisocabtagene maraleucel in R/R LBCL. Blood. 2026 Jun 3:blood.2025032270. doi: 10.1182/blood.2025032270. Online ahead of print.

    PubMed 42237652

  • Abramson JS, Palomba ML, Gordon LI, Lunning M, Wang M, Arnason J, Purev E, Maloney DG, Andreadis C, Sehgal A, Solomon SR, Ghosh N, Dehner C, Kim Y, Ogasawara K, Kostic A, Siddiqi T. Two-year follow-up of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphoma in TRANSCEND NHL 001. Blood. 2024 Feb 1;143(5):404-416. doi: 10.1182/blood.2023020854.

    PubMed 37890149

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Gene-modified (GM) T cell therapy in people with Neoplasms, run by Celgene at 225 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 225 sites in United States, France, Germany, Japan, Spain and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of delayed Adverse Events (AEs) (time frame: Up to 15 years from last gene-modified (GM) T cell infusion). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03435796, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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