Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
- Conditions
- Neoplasms
- Interventions
- Genetic: Gene-modified (GM) T cell therapy
- Registration Number
- NCT03435796
- Lead Sponsor
- Celgene
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1541
- Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored 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.
Not Applicable
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants exposed to Gene-modified (GM) T cell therapy Gene-modified (GM) T cell therapy -
- Primary Outcome Measures
Name Time Method Incidence of delayed Adverse Events (AEs) Up to 15 years from last gene-modified (GM) T cell infusion Persistence of GM T cells Up to 15 years from last GM T cell infusion Analysis of vector integration sites Up to 15 years from last GM T cell infusion Incidence of replication-competent lentiviruses Up to 15 years from last GM T cell infusion Physical growth as assessed by physical examination (pediatric participants only) Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only) Up to 15 years from last GM T cells infusion or until Tanner Stage 5 Proportion of participants who progressed on the study: participants with original diagnosis of malignancies Up to 15 years from last GM T cells infusion Number of participants with reintroduction of standard treatments for the control of autoimmune disease activity as a surrogate for disease relapse Up to 15 years from last GM T cells infusion Participants with autoimmune diseases
Overall Survival (participants with original diagnosis of malignancies) Up to 15 years from last GM T cells infusion
- Secondary Outcome Measures
Name Time Method Lymphocyte count (B-cell) Up to 15 years If B-cell recovery criteria are not met at Month 60 (Year 5), then annual monitoring will continue until B-cell recovery is confirmed on 2 consecutive analyses or up to 15 years, until subject withdrawal of consent, or death, whichever occurs first.
Trial Locations
- Locations (179)
Karolinska University Hospital Huddinge
🇸🇪Stockholm, Sweden
Inselspital Bern
🇨🇭Bern, Switzerland
Local Institution - 10850
🇬🇧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, United Kingdom
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Mayo Clinic Phoenix
🇺🇸Phoenix, Arizona, United States
Arizona Cancer Center
🇺🇸Scottsdale, Arizona, United States
Local Institution - 01021
🇺🇸Tucson, Arizona, United States
City Of Hope
🇺🇸Duarte, California, United States
University Of California San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Local Institution - 01206
🇺🇸Los Angeles, California, United States
Local Institution - 01043
🇺🇸Sacramento, California, United States
University of California, San Francisco- California
🇺🇸San Francisco, California, United States
UCLA Medical Centre-Santa Monica
🇺🇸Santa Monica, California, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
University Of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Local Institution - 01050
🇺🇸Washington, District of Columbia, United States
The Mayo Clinic - Jacksonville, Davis-E
🇺🇸Jacksonville, Florida, United States
Baptist Cancer Center
🇺🇸Miami, Florida, United States
Local Institution - 01035
🇺🇸Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute University of South Florida
🇺🇸Tampa, Florida, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Northside Hospital, Inc
🇺🇸Atlanta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University Of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Local Institution - 01040
🇺🇸Maywood, Illinois, United States
Local Institution - 01063
🇺🇸Niles, Illinois, United States
IN Univ Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Local Institution - 01020
🇺🇸Indianapolis, Indiana, United States
Kansas University Medical Center
🇺🇸Westwood, Kansas, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
University Of Kentucky
🇺🇸Lexington, Kentucky, United States
Norton Cancer Institute Louisville Oncology
🇺🇸Louisville, Kentucky, United States
Local Institution - 01026
🇺🇸New Orleans, Louisiana, United States
University of Maryland - Greenebaum Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Sidney Kimmel Comp Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
National Cancer Institute
🇺🇸Bethesda, Maryland, United States
Local Institution - 01107
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital / Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Local Institution - 01106
🇺🇸Boston, Massachusetts, United States
University Of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Karmanos Cancer Center Wayne State University
🇺🇸Detroit, Michigan, United States
Providence Cancer Institute
🇺🇸Southfield, Michigan, United States
M Health Fairview University of Minnesota Medical Center - East Bank
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Local Institution - UNK 2
🇧🇪Leuven, Belgium
Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
University Of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Local Institution - 01030
🇺🇸East Brunswick, New Jersey, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Morristown Memorial Hosp
🇺🇸Morristown, New Jersey, United States
Local Institution - 01053
🇺🇸New Brunswick, New Jersey, United States
New York Oncology Hematology P.C.
🇺🇸Albany, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Local Institution - 01066
🇺🇸New York, New York, United States
Weill Cornell Medicine / New York Presbyterian Hospital
🇺🇸New York, New York, United States
Icahn School Of Medicine At Mount Sinai
🇺🇸New York, New York, United States
Columbia University Medical Center/New York-Presbyterian Hospital
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Local Institution - 01051
🇺🇸Rochester, New York, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Novant Health
🇺🇸Salisbury, North Carolina, United States
Oncology Hematology Care, Inc.
🇺🇸Cincinnati, Ohio, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Local Institution - 01074
🇺🇸Columbus, Ohio, United States
Hospital Virgen Del Rocio
🇪🇸Sevilla, Spain
University of Oklahoma Peggy and Charles Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute
🇺🇸Eugene, Oregon, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Oregon Health and Science University OHSU
🇺🇸Portland, Oregon, United States
Children's Hospital of Philadelphia-Center for Childhood Cancer Research
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University - Clinical Research Institute
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Cancer Pavillion
🇺🇸Pittsburgh, Pennsylvania, United States
Hematology and Oncology Associates of SC, LLC
🇺🇸Greenville, South Carolina, United States
Local Institution - 01064
🇺🇸Sioux Falls, South Dakota, United States
Sarah Cannon Research Inst
🇺🇸Nashville, Tennessee, United States
Texas Oncology
🇺🇸Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Texas- MD Anderson
🇺🇸Houston, Texas, United States
Sam Clinical Research Center
🇺🇸San Antonio, Texas, United States
Local Institution - 01033
🇺🇸Temple, Texas, United States
Texas Oncology, P.A. - Tyler
🇺🇸Tyler, Texas, United States
University of Utah - Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Intermountain Healthcare - LDS Hospital
🇺🇸Salt Lake City, Utah, United States
University Of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Local Institution - 01045
🇺🇸Norfolk, Virginia, United States
Local Institution - 01023
🇺🇸Richmond, Virginia, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Local Institution - 01060
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
Local Institution - 01055
🇺🇸Tacoma, Washington, United States
University Of Wisconsin
🇺🇸Madison, Wisconsin, United States
Froedtert Hospital BMT Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Local Institution - 01069
🇺🇸Wauwatosa, Wisconsin, United States
Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien
🇦🇹Wien, Austria
Local Institution - 05202
🇧🇪Anderlecht, Belgium
Universitair Ziekenhuis Brussel
🇧🇪Brussel, Belgium
Local Institution - 05200
🇧🇪Gent, Belgium
Uz Gent
🇧🇪Gent, Belgium
University Hospital Leuven
🇧🇪Leuven, Belgium
University Of Calgary
🇨🇦Calgary, Alberta, Canada
Local Institution - 02802
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 02801
🇨🇦Hamilton, Ontario, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
CIUSSS de l'Est-de-l'Ile-de-Montreal
🇨🇦Montreal, Quebec, Canada
Helsinki University Central Hospital (HUCH)
🇫🇮Helsinki, Finland
Hopital Henri Mondor
🇫🇷Creteil-Paris, France
CHRU de Lille France
🇫🇷Lille Cedex, France
Local Institution - 09601
🇫🇷Lyon, France
Local Institution - 09400
🇫🇷Marseille Cedex 9, France
Local Institution - 09602
🇫🇷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
Local Institution - 09600
🇫🇷Paris, France
Local Institution - 09210
🇫🇷Pessac, France
Centre Hospitalier Lyon-Sud
🇫🇷Pierre-Benite CEDEX, France
CHU La Miletrie
🇫🇷Poitiers Cedex, France
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Toranomon Hospital
🇯🇵Minato-ku, Tokyo, Japan
Local Institution - 13202
🇯🇵Bunkyo-ku, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Tokai University Hospital
🇯🇵Isehara City, Kanagawa, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Japan
Osaka Metropolitan university Hospital
🇯🇵Osaka, Japan
Japan Red Cross Medical Center
🇯🇵Shibuya-ku, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Japan
Local Institution - 13804
🇯🇵Shinjuku City, Japan
Local Institution - 04650
🇳🇱Amsterdam, Netherlands
Erasmus Medical Center - Daniel den Hoed
🇳🇱Rotterdam, Netherlands
Local Institution - 04400
🇳🇱Utrecht, Netherlands
Oslo Universitetssykehus
🇳🇴Oslo, Norway
Institutul Clinic Fundeni
🇷🇴Bucuresti, Romania
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
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
🇪🇸Salamanca, Spain
Institut Universitaire du Cancer de Toulouse - Oncopole
🇫🇷Toulouse CEDEX 9, France
Gustave Roussy
🇫🇷Villejuif, France
Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. Tumorimmuno
🇩🇪Berlin, Germany
Local Institution - 03155
🇩🇪Berlin, Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden
🇩🇪Dresden, Germany
Local Institution - 03513
🇩🇪Dusseldorf, Germany
Local Institution - 03500
🇩🇪Frankfurt, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitatsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Kinikum der Universitaeat zu Koeln
🇩🇪Koeln, Germany
Local Institution - 03454
🇩🇪Muenster, Germany
LMU Klinikum der Universität
🇩🇪München, Germany
Local Institution - 03503
🇩🇪Tuebingen, Germany
University Hospital of Ulm
🇩🇪Ulm, Germany
Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II
🇩🇪Würzburg, Germany
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
🇮🇹Naples, Italy
Local Institution - 07500
🇮🇹Roma, Italy
Ospedale Pediatrico Bambino Gesu
🇮🇹Rome, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Italy
Local Institution - 07610
🇮🇹Torino, Italy
Azienda Sanitaria Ospedaliera San Giovanni Battista Molinette
🇮🇹Turin, Italy
Hokkaido University Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan