Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03435796 Recruiting February 19, 2018 August 2, 2022

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

Condition or Disease: Neoplasms
Intervention/treatment: Genetic: Gene-modified (GM) T cell therapy
Phase: Phase 2/Phase 3
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 191 participants
Intervention Model : Single Group Assignment
Masking: None (Open Label) ()
Primary Purpose: Other
Official Title: Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Actual Study Start Date: June 2018
Estimated Primary Completion Date: November 2036
Estimated Study Completion Date: November 2036

Arms and interventions
Arm Intervention/treatment
Other: Participants exposed to Gene-modified (GM) T cell therapy
Genetic: Gene-modified (GM) T cell therapy
No investigational product will be administered
outcome measures
Primary Outcome Measures: 1. Incidence of delayed Adverse Events (AEs) [ Time Frame: Up to 15 years from last gene-modified (GM) T cell infusion ]
2. Persistence of GM T cells [ Time Frame: Up to 15 years from last GM T cell infusion ]
3. Analysis of vector integration sites [ Time Frame: Up to 15 years from last GM T cell infusion ]
4. Incidence of replication-competent lentiviruses [ Time Frame: Up to 15 years from last GM T cell infusion ]
5. Physical growth as assessed by physical examination (pediatric participants only) [ Time Frame: 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) [ Time Frame: Up to 15 years from last GM T cells infusion or until Tanner Stage 5 ]
7. Disease status of the primary malignancy [ Time Frame: Up to 15 years from last GM T cell infusion ]
8. Disease Progression: Number of participants who continue to be responders, who have progressed, and who have relapsed will be reported. [ Time Frame: Up to 15 years from last GM T cells infusion ]
9. Disease Relapse: Number of participants who continue to be responders, who have progressed, and who have relapsed will be reported. [ Time Frame: Up to 15 years from last GM T cells infusion ]
10. Overall Survival defined as the time from the first dose of investigational product or from the randomization date to the date of death or the date the participant is last known to be alive. [ Time Frame: Up to 15 years from last GM T cells infusion ]
Secondary Outcome Measures: 1. Health-related quality of life (HRQoL): Measurement of HRQoL changes as assessed using instruments administered in the parent treatment protocol [ Time Frame: Up to approximately 5 years from last GM T cell infusion ]

Eligibility Criteria
Ages Eligible for Study: (Child, Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored or Celgene alliance partner-sponsored study, 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.

Exclusion Criteria:

Not Applicable

Other protocol-defined inclusion/exclusion criteria apply


Contacts and Locations
Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

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

Locations
United States, Alabama University of Alabama Birmingham Birmingham
United States, Alabama University of Alabama Birmingham Birmingham
United States, Arizona Banner MD Anderson Cancer Center Gilbert
United States, Arizona Mayo Clinic Phoenix Phoenix
United States, Arizona Arizona Cancer Center Scottsdale
United States, California City of Hope Duarte
United States, California University of California San Diego Moores Cancer Center La Jolla
United States, California Cedars-Sinai Medical Center Los Angeles
United States, California Sutter Hematology and Oncology Sacramento
United States, California University of California, San Francisco- California San Francisco
United States, California UCLA Medical Centre-Santa Monica Santa Monica
United States, California Stanford Cancer Center Stanford
United States, Colorado University of Colorado Cancer Center Aurora
United States, Colorado Colorado Blood Cancer Institute Denver
United States, Connecticut Yale Cancer Center New Haven
United States, District of Columbia Lombardi Cancer Center - Georgetown University Hospital Washington
United States, Florida The Mayo Clinic - Jacksonville, Davis-E Jacksonville
United States, Florida The Mayo Clinic - Jacksonville, Davis-E Jacksonville
United States, Florida Baptist Cancer Center Miami
United States, Florida Florida Hospital Transplant Institute Orlando
United States, Florida H. Lee Moffitt Cancer Center and Research Institute University of South Florida Tampa
United States, Georgia Winship Cancer Institute of Emory University Atlanta
United States, Georgia Northside Hospital, Inc Atlanta
United States, Illinois Northwestern Memorial Hospital Chicago
United States, Illinois University of Chicago Medical Center Chicago
United States, Illinois Loyola University Medical Center Maywood
United States, Illinois Illinois Cancer Specialists Niles
United States, Indiana IN Univ Simon Cancer Center Indianapolis
United States, Indiana IN Univ Simon Cancer Center Indianapolis
United States, Indiana Franciscan St. Francis Health - Indiana Blood and Marrow Transplantation (IBMT) Indianapolis
United States, Kansas Kansas University Medical Center Westwood
United States, Kansas Cancer Center of Kansas Wichita
United States, Kentucky University of Kentucky Lexington
United States, Kentucky Norton Cancer Institute Louisville Oncology Louisville
United States, Maryland University of Maryland - Greenebaum Comprehensive Cancer Center Baltimore
United States, Maryland Sidney Kimmel Comp Cancer Center at Johns Hopkins Baltimore
United States, Maryland National Cancer Institute Bethesda
United States, Massachusetts Massachusetts General Hospital / Dana-Farber Cancer Institute Boston
United States, Massachusetts Massachusetts General Hospital / Dana-Farber Cancer Institute Boston
United States, Massachusetts Dana-Farber/Mass General Brigham Cancer Care, Inc Boston
United States, Michigan University of Michigan Comprehensive Cancer Center Ann Arbor
United States, Michigan Karmanos Cancer Center Wayne State University Detroit
United States, Michigan Providence Cancer Institute Southfield
United States, Minnesota University of Minnesota Minneapolis
United States, Minnesota Mayo Clinic Rochester
United States, Missouri Siteman Cancer Center Saint Louis
United States, Nebraska University of Nebraska Medical Center Omaha
United States, New Jersey Regional Cancer Care Associates LLC East Brunswick
United States, New Jersey Hackensack University Medical Center Hackensack
United States, New Jersey Morristown Memorial Hosp Morristown
United States, New Jersey Rutgers Cancer Institute of New Jersey New Brunswick
United States, New York New York Oncology Hematology P.C. Albany
United States, New York Roswell Park Cancer Institute Buffalo
United States, New York NYU Langone Laura and Isaac Perlmutter Cancer Center New York
United States, New York Weill Cornell Medicine / New York Presbyterian Hospital New York
United States, New York Icahn School of Medicine at Mount Sinai New York
United States, New York Columbia University Medical Center/New York-Presbyterian Hospital New York
United States, New York Memorial Sloan Kettering Cancer Center New York
United States, New York University of Rochester James P. Wilmot Cancer Center Rochester
United States, North Carolina Levine Cancer Institute Charlotte
United States, North Carolina Duke University Medical Center Durham
United States, Ohio Oncology Hematology Care, Inc. Cincinnati
United States, Ohio University Hospitals of Cleveland Cleveland
United States, Ohio Cleveland Clinic Foundation Cleveland
United States, Oklahoma University of Oklahoma Peggy and Charles Stephenson Cancer Center Oklahoma City
United States, Oregon Willamette Valley Cancer Institute Eugene
United States, Oregon Providence Portland Medical Center Portland
United States, Oregon Oregon Health and Science University OHSU Portland
United States, Pennsylvania The Children's Hospital of Philadelphia Philadelphia
United States, Pennsylvania University of Pennsylvania Perelman Center for Advanced Medicine Philadelphia
United States, Pennsylvania Thomas Jefferson University Philadelphia
United States, Pennsylvania Fox Chase Cancer Center Philadelphia
United States, Pennsylvania UPMC Cancer Pavillion Pittsburgh
United States, South Carolina Hematology and Oncology Associates of SC, LLC Greenville
United States, South Dakota Avera Cancer Institute Sioux Falls
United States, Tennessee Sarah Cannon Research Inst Nashville
United States, Texas Texas Oncology Dallas
United States, Texas Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas
United States, Texas UT Southwestern Medical Center Dallas
United States, Texas University of Texas- MD Anderson Houston
United States, Texas SAM Clinical Research Center San Antonio
United States, Texas Baylor Scott and White Health Temple
United States, Texas Texas Oncology, P.A. - Tyler Tyler
United States, Utah University of Utah - Huntsman Cancer Institute Salt Lake City
United States, Utah Intermountain Healthcare - LDS Hospital Salt Lake City
United States, Virginia University of Virginia Health System Charlottesville
United States, Virginia Virginia Oncology Associates Norfolk
United States, Virginia Virginia Commonwealth University Richmond
United States, Washington Swedish Cancer Institute Seattle
United States, Washington Seattle Children's Hospital Seattle
United States, Washington Fred Hutchinson Cancer Research Center Seattle
United States, Washington Northwest Medical Specialties PLLC Tacoma
United States, Wisconsin University Of Wisconsin Madison
United States, Wisconsin University Of Wisconsin Madison
United States, Wisconsin Froedtert Hospital BMT Medical College of Wisconsin Milwaukee
United States, Wisconsin Froedtert Hospital BMT Medical College of Wisconsin Milwaukee
Austria Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien Wien
Belgium Local Institution - 05351 Gent
Belgium UZ Gent Gent
Belgium University Hospital Leuven Leuven
Canada, Alberta University of Calgary Calgary
Canada, British Columbia Vancouver General Hospital Vancouver
Canada, Ontario Juravinski Cancer Centre Hamilton
Canada, Ontario Princess Margaret Cancer Centre Toronto
Canada, Quebec CIUSSS de l'Est-de-l'Ile-de-Montreal Montreal
Finland Helsinki University Central Hospital (HUCH) Helsinki
France CHRU de Lille France Lille Cedex
France Institute for Pediatric Hematology - Oncology, Leon Berard Cancer Center Lyon
France Institut Paoli-Calmettes Marseille Cedex 9
France Hopitaux de La Timone Marseille Cedex 9
France CHU Montpellier - Hôpital Saint Eloi Montpellier CEDEX 5
France CHU Hotel Dieu Nantes Cedex 01
France Hopital Saint Louis Paris
France Hospital Saint Louis Paris
France Hopital Robert Debre Paris
France Centre Hospitalier Lyon-Sud Pierre-Benite CEDEX
France CHU La Miletrie Poitiers Cedex
France Institut Universitaire du Cancer de Toulouse - Oncopole Toulouse CEDEX 9
France Gustave Roussy Villejuif
Germany Robert-Rössle-Klinik im HELIOS Klinikum Berlin-Buch Klinik für Hämatologie, Onkologie u. Tumorimmuno Berlin
Germany Charite -Universitätsmedizin Berlin Berlin
Germany Universitatsklinikum Carl Gustav Carus an der TU Dresden Dresden
Germany Hematology Oncology and clinical immunology / Heinrich-Heine-University Dusseldorf
Germany Medizinische Klinik II ZIM,Hamatologie Onkologie Uniklinik Frankfurt Frankfurt
Germany Universitaetsklinikum Hamburg-Eppendorf Hamburg
Germany Universitatsklinikum Heidelberg Heidelberg
Germany Kinikum der Universitaeat zu Koeln Koeln
Germany Universitaetsklinikum Muenster Muenster
Germany LMU Klinikum der Universität München
Germany Universitaetsklinikum Tuebingen Tuebingen
Germany University Hospital of Ulm Ulm
Germany Local Institution - 03501 Würzburg
Germany Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II Würzburg
Italy Ospedali Riuniti di Ancona Ancona
Italy Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi Bologna
Italy Fondazione IRCCS Istituto Nazionale dei Tumori Milan
Italy Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM) Monza
Italy Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Napoli
Italy Universita La Sapienza Roma
Italy Ospedale Pediatrico Bambino Gesu Rome
Italy Istituto Clinico Humanitas Rozzano (MI)
Italy Azienda Ospedaliera Citta della Salute e della Scienza di Torino Torino
Italy Azienda Sanitaria Ospedaliera San Giovanni Battista Molinette Turin
Japan Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Bunkyo-ku
Japan National Cancer Center Hospital Chuo-ku
Japan Kyushu University Hospital Fukuoka
Japan Tokai University Hospital Isehara City, Kanagawa
Japan Toranomon Hospital Minato-ku
Japan Local Institution - 13203 Osaka
Japan Osaka City University Hospital Osaka
Japan Hokkaido University Hospital Sapporo, Hokkaidô
Japan Japan Red Cross Medical Center Shibuya-ku
Japan Jichi Medical University Hospital Shimotsuke
Japan Tokyo Women's Medical University Hospital Shinjuku City
Netherlands Vrije Universiteit Medisch Centrum (VUMC) Amsterdam
Netherlands Erasmus Medical Center - Daniel den Hoed Rotterdam
Netherlands Princess Maxima Center for Pediatric Oncology Utrecht
Norway Oslo Universitetssykehus Oslo
Spain Hospital Universitario Vall D hebron Barcelona
Spain Hospital Universitari Germans Trias i Pujol ICO Badalona Barcelona
Spain Institut Clinic de Nefrologia i Urologia - Hospital Clinic i Provincial de Barcelona Barcelona
Spain Hospital San Joan de Deu Barcelona Esplugues de Llobregat
Spain Hospital Infantil Universitario Nino Jesus Madrid
Spain Hospital 12 de Octubre Madrid
Spain Clinica Universidad de Navarra Pamplona
Spain Universitario de Salamanca - Hospital Clinico Salamanca
Spain Hospital Virgen del Rocio Sevilla
Sweden Karolinska University Hospital Huddinge Stockholm
Switzerland Inselspital Bern Bern
United Kingdom The Leeds Teaching Hospitals NHS Trust - St James's University Hospital Leeds
United Kingdom Kings College Hospital London
United Kingdom UCL Cancer Institute London
United Kingdom Christie Hospital NHS Trust Manchester Withington
United Kingdom Somers Cancer Research Building Shirley Southampton
Sponsors and Collaborators
Celgene
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Celgene
ClinicalTrials.gov Identifier : NCT03435796     
Other Study ID Numbers : GC-LTFU-001, U1111-1206-8250, 2017-001465-24
First Posted : February 19, 2018
Last Update Posted : August 2, 2022
Last Verified : August 2022
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene: Long-term follow up
Gene-Modified T Cells
CAR T Cell