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

  • Clinicaltrials.gov identifier

    NCT03435796

  • Recruitment Status

    Recruiting

  • First Posted

    February 19, 2018

  • Last update posted

    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

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03435796 History of Changes
  • Other Study ID Numbers: GC-LTFU-001, U1111-1206-8250, 2017-001465-24
  • First Posted: February 19, 2018 Key Record Dates
  • 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