Clinical trial NCT03435796: Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Official title: Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Neoplasms
Keywords: Long-term follow up
Gene-Modified T Cells
CAR T Cell
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 1541
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

Not Applicable

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Incidence of delayed Adverse Events (AEs)
timeFrame: Up to 15 years from last gene-modified (GM) T cell infusion
measure: Persistence of GM T cells
timeFrame: Up to 15 years from last GM T cell infusion
measure: Analysis of vector integration sites
timeFrame: Up to 15 years from last GM T cell infusion
measure: Incidence of replication-competent lentiviruses
timeFrame: Up to 15 years from last GM T cell infusion
measure: Physical growth as assessed by physical examination (pediatric participants only)
timeFrame: Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached
measure: Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only)
timeFrame: Up to 15 years from last GM T cells infusion or until Tanner Stage 5
measure: Proportion of participants who progressed on the study: participants with original diagnosis of malignancies
timeFrame: Up to 15 years from last GM T cells infusion
measure: Number of participants with reintroduction of standard treatments for the control of autoimmune disease activity as a surrogate for disease relapse
timeFrame: Up to 15 years from last GM T cells infusion
measure: Overall Survival (participants with original diagnosis of malignancies)
timeFrame: Up to 15 years from last GM T cells infusion
Secondary outcomes:
measure: Lymphocyte count (B-cell)
timeFrame: Up to 15 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Phoenix
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Tucson
country: United States
facility: Local Institution - 01021
state: Arizona
city: Duarte
country: United States
facility: City Of Hope
state: California
city: La Jolla
country: United States
facility: University Of California San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: Local Institution - 01206
state: California
city: Sacramento
country: United States
facility: Local Institution - 01043
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco- California
state: California
city: Santa Monica
country: United States
facility: UCLA Medical Centre-Santa Monica
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Aurora
country: United States
facility: University Of Colorado Cancer Center
state: Colorado
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Local Institution - 01050
state: District of Columbia
city: Jacksonville
country: United States
facility: The Mayo Clinic - Jacksonville, Davis-E
state: Florida
city: Miami
country: United States
facility: Baptist Cancer Center
state: Florida
city: Orlando
country: United States
facility: Local Institution - 01035
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital, Inc
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University Of Chicago Medical Center
state: Illinois
city: Maywood
country: United States
facility: Local Institution - 01040
state: Illinois
city: Niles
country: United States
facility: Local Institution - 01063
state: Illinois
city: Indianapolis
country: United States
facility: IN Univ Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Local Institution - 01020
state: Indiana
city: Westwood
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Lexington
country: United States
facility: University Of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute Louisville Oncology
state: Kentucky
city: New Orleans
country: United States
facility: Local Institution - 01026
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland - Greenebaum Comprehensive Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comp Cancer Center at Johns Hopkins
state: Maryland
city: Bethesda
country: United States
facility: National Cancer Institute
state: Maryland
city: Boston
country: United States
facility: Local Institution - 01107
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital / Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 01106
state: Massachusetts
city: Ann Arbor
country: United States
facility: University Of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Center Wayne State University
state: Michigan
city: Southfield
country: United States
facility: Providence Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center - East Bank
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Siteman Cancer Center
state: Missouri
city: Omaha
country: United States
facility: University Of Nebraska Medical Center
state: Nebraska
city: East Brunswick
country: United States
facility: Local Institution - 01030
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hosp
state: New Jersey
city: New Brunswick
country: United States
facility: Local Institution - 01053
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology P.C.
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Local Institution - 01066
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine / New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Icahn School Of Medicine At Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/New York-Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: Local Institution - 01051
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Salisbury
country: United States
facility: Novant Health
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 01074
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University OHSU
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia-Center for Childhood Cancer Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman Center for Advanced Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University - Clinical Research Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Pavillion
state: Pennsylvania
city: Greenville
country: United States
facility: Hematology and Oncology Associates of SC, LLC
state: South Carolina
city: Sioux Falls
country: United States
facility: Local Institution - 01064
state: South Dakota
city: Nashville
country: United States
facility: Sarah Cannon Research Inst
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas- MD Anderson
state: Texas
city: San Antonio
country: United States
facility: Sam Clinical Research Center
state: Texas
city: Temple
country: United States
facility: Local Institution - 01033
state: Texas
city: Tyler
country: United States
facility: Texas Oncology, P.A. - Tyler
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - Huntsman Cancer Institute
state: Utah
city: Salt Lake City
country: United States
facility: Intermountain Healthcare - LDS Hospital
state: Utah
city: Charlottesville
country: United States
facility: University Of Virginia Health System
state: Virginia
city: Norfolk
country: United States
facility: Local Institution - 01045
state: Virginia
city: Richmond
country: United States
facility: Local Institution - 01023
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Local Institution - 01060
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Tacoma
country: United States
facility: Local Institution - 01055
state: Washington
city: Madison
country: United States
facility: University Of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Hospital BMT Medical College of Wisconsin
state: Wisconsin
city: Wauwatosa
country: United States
facility: Local Institution - 01069
state: Wisconsin
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Wien
country: Austria
facility: Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien
city: Anderlecht
country: Belgium
facility: Local Institution - 05202
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Gent
country: Belgium
facility: Local Institution - 05200
city: Gent
country: Belgium
facility: Uz Gent
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Leuven
country: Belgium
facility: Local Institution - UNK 2
city: Calgary
country: Canada
facility: University Of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution - 02802
state: British Columbia
city: Hamilton
country: Canada
facility: Local Institution - 02801
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Ile-de-Montreal
state: Quebec
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital (HUCH)
city: Creteil-Paris
country: France
facility: Hopital Henri Mondor
city: Lille Cedex
country: France
facility: CHRU de Lille France
city: Lyon
country: France
facility: Local Institution - 09601
city: Marseille Cedex 9
country: France
facility: Local Institution - 09400
city: Marseille Cedex 9
country: France
facility: Local Institution - 09602
city: Montpellier CEDEX 5
country: France
facility: CHU Montpellier - Hôpital Saint Eloi
city: Nantes Cedex 01
country: France
facility: Chu Hotel Dieu
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hospital Saint Louis
city: Paris
country: France
facility: Local Institution - 09600
city: Pessac
country: France
facility: Local Institution - 09210
city: Pierre-Benite CEDEX
country: France
facility: Centre Hospitalier Lyon-Sud
city: Poitiers Cedex
country: France
facility: CHU La Miletrie
city: Toulouse CEDEX 9
country: France
facility: Institut Universitaire du Cancer de Toulouse - Oncopole
city: Villejuif
country: France
facility: Gustave Roussy
city: Berlin
country: Germany
facility: Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. Tumorimmuno
city: Berlin
country: Germany
facility: Local Institution - 03155
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden
city: Dusseldorf
country: Germany
facility: Local Institution - 03513
city: Frankfurt
country: Germany
facility: Local Institution - 03500
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitatsklinikum Heidelberg
city: Koeln
country: Germany
facility: Kinikum der Universitaeat zu Koeln
city: Muenster
country: Germany
facility: Local Institution - 03454
city: München
country: Germany
facility: LMU Klinikum der Universität
city: Tuebingen
country: Germany
facility: Local Institution - 03503
city: Ulm
country: Germany
facility: University Hospital of Ulm
city: Würzburg
country: Germany
facility: Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II
city: Ancona
country: Italy
facility: Ospedali Riuniti di Ancona
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Monza
country: Italy
facility: Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM)
city: Naples
country: Italy
facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
city: Roma
country: Italy
facility: Local Institution - 07500
city: Rome
country: Italy
facility: Ospedale Pediatrico Bambino Gesu
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
city: Torino
country: Italy
facility: Local Institution - 07610
city: Turin
country: Italy
facility: Azienda Sanitaria Ospedaliera San Giovanni Battista Molinette
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Local Institution - 13202
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Isehara City, Kanagawa
country: Japan
facility: Tokai University Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan university Hospital
city: Shibuya-ku
country: Japan
facility: Japan Red Cross Medical Center
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
city: Shinjuku City
country: Japan
facility: Local Institution - 13804
city: Amsterdam
country: Netherlands
facility: Local Institution - 04650
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center - Daniel den Hoed
city: Utrecht
country: Netherlands
facility: Local Institution - 04400
city: Oslo
country: Norway
facility: Oslo Universitetssykehus
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D hebron
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol ICO Badalona
city: Barcelona
country: Spain
facility: Institut Clinic de Nefrologia i Urologia - Hospital Clinic i Provincial de Barcelona
city: Esplugues de Llobregat
country: Spain
facility: Hospital San Joan de Deu Barcelona
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus
city: Madrid
country: Spain
facility: Hospital 12 De Octubre
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Virgen Del Rocio
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Leeds
country: United Kingdom
facility: Local Institution - 10850
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: UCL Cancer Institute
city: Manchester Withington
country: United Kingdom
facility: Christie Hospital Nhs Trust
city: Shirley Southampton
country: United Kingdom
facility: Somers Cancer Research Building
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: