Neoplasms Clinical Trial
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 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.
| Status | Recruiting |
| Enrollment | 317 |
| Est. completion date | November 30, 2036 |
| Est. primary completion date | November 30, 2036 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien | Wien | |
| Belgium | Local Institution - 05200 | Gent | |
| Belgium | Uz Gent | Gent | |
| Belgium | Local Institution - UNK 2 | Leuven | |
| Belgium | University Hospital Leuven | Leuven | |
| Canada | University Of Calgary | Calgary | Alberta |
| Canada | Local Institution - 02801 | Hamilton | Ontario |
| Canada | Local Institution - 02800 | Montreal | Quebec |
| Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
| Canada | Local Institution - 02802 | Vancouver | British Columbia |
| Finland | Helsinki University Central Hospital (HUCH) | Helsinki | |
| 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 | 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 | Local Institution - 03155 | Berlin | |
| Germany | Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. Tumorimmuno | 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 | Universitaetsklinikum Tuebingen | Tuebingen | |
| Germany | University Hospital of Ulm | Ulm | |
| 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 | 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 | |
| Japan | Local Institution - 13202 | Bunkyo-ku | |
| Japan | National Cancer Center Hospital | Chuo-ku | Tokyo |
| Japan | Kyushu University Hospital | Fukuoka | |
| Japan | Tokai University Hospital | Isehara City, Kanagawa | |
| Japan | Toranomon Hospital | Minato-ku | Tokyo |
| Japan | Nagoya City University Hospital | Nagoya | |
| Japan | Osaka Metropolitan university Hospital | Osaka | |
| Japan | Hokkaido University Hospital | Sapporo-shi | Hokkaido |
| Japan | Japan Red Cross Medical Center | Shibuya-ku | |
| Japan | Jichi Medical University Hospital | Shimotsuke | |
| Japan | Local Institution - 13804 | Shinjuku City | |
| Netherlands | Local Institution - 04650 | Amsterdam | |
| Netherlands | Erasmus Medical Center - Daniel den Hoed | Rotterdam | |
| Netherlands | Local Institution - 04400 | Utrecht | |
| Norway | Oslo Universitetssykehus | Oslo | |
| Spain | Hospital Universitari Germans Trias i Pujol ICO Badalona | Barcelona | |
| Spain | Hospital Universitario Vall D hebron | 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 12 De Octubre | Madrid | |
| Spain | Hospital Infantil Universitario Nino Jesus | Madrid | |
| Spain | Clinica Universidad de Navarra | Pamplona | |
| Spain | Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca | Salamanca | |
| Spain | Hospital Virgen Del Rocio | Sevilla | |
| Sweden | Karolinska University Hospital Huddinge | Stockholm | |
| Switzerland | Inselspital Bern | Bern | |
| United Kingdom | 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 States | New York Oncology Hematology P.C. | Albany | New York |
| United States | University Of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
| United States | Northside Hospital, Inc | Atlanta | Georgia |
| United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
| United States | University Of Colorado Cancer Center | Aurora | Colorado |
| United States | Sidney Kimmel Comp Cancer Center at Johns Hopkins | Baltimore | Maryland |
| United States | University of Maryland - Greenebaum Comprehensive Cancer Center | Baltimore | Maryland |
| United States | National Cancer Institute | Bethesda | Maryland |
| United States | University of Alabama Birmingham | Birmingham | Alabama |
| United States | Local Institution - 01106 | Boston | Massachusetts |
| United States | Local Institution - 01107 | Boston | Massachusetts |
| United States | Massachusetts General Hospital / Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | Levine Cancer Institute | Charlotte | North Carolina |
| United States | University Of Virginia Health System | Charlottesville | Virginia |
| United States | Northwestern Memorial Hospital | Chicago | Illinois |
| United States | University Of Chicago Medical Center | Chicago | Illinois |
| United States | Oncology Hematology Care, Inc. | Cincinnati | Ohio |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Local Institution - 01042 | Cleveland | Ohio |
| 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 | Colorado Blood Cancer Institute | Denver | Colorado |
| United States | Karmanos Cancer Center Wayne State University | Detroit | Michigan |
| United States | City Of Hope | Duarte | California |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Local Institution - 01030 | East Brunswick | New Jersey |
| United States | Willamette Valley Cancer Institute | Eugene | Oregon |
| United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
| United States | Hematology and Oncology Associates of SC, LLC | Greenville | South Carolina |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | University of Texas- MD Anderson | Houston | Texas |
| United States | IN Univ Simon Cancer Center | Indianapolis | Indiana |
| United States | Local Institution - 01020 | Indianapolis | Indiana |
| United States | The Mayo Clinic - Jacksonville, Davis-E | Jacksonville | Florida |
| United States | University Of California San Diego Moores Cancer Center | La Jolla | California |
| United States | University Of Kentucky | Lexington | Kentucky |
| United States | Local Institution - 01206 | Los Angeles | California |
| United States | Norton Cancer Institute Louisville Oncology | Louisville | Kentucky |
| United States | University Of Wisconsin | Madison | Wisconsin |
| United States | Local Institution - 01040 | Maywood | Illinois |
| United States | Baptist Cancer Center | Miami | Florida |
| United States | Froedtert Hospital BMT Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | M Health Fairview University of Minnesota Medical Center - East Bank | Minneapolis | Minnesota |
| United States | Morristown Memorial Hosp | Morristown | New Jersey |
| United States | Sarah Cannon Research Inst | Nashville | Tennessee |
| United States | Local Institution - 01053 | New Brunswick | New Jersey |
| United States | Yale Cancer Center | New Haven | Connecticut |
| United States | Local Institution - 01026 | New Orleans | Louisiana |
| United States | Columbia University Medical Center/New York-Presbyterian Hospital | New York | New York |
| United States | Icahn School Of Medicine At Mount Sinai | New York | New York |
| United States | Local Institution - 01066 | New York | New York |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Weill Cornell Medicine / New York Presbyterian Hospital | New York | New York |
| United States | Local Institution - 01063 | Niles | Illinois |
| United States | Local Institution - 01045 | Norfolk | Virginia |
| United States | University of Oklahoma Peggy and Charles Stephenson Cancer Center | Oklahoma City | Oklahoma |
| United States | University Of Nebraska Medical Center | Omaha | Nebraska |
| United States | Local Institution - 01035 | Orlando | Florida |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | The Children'S Hospital Of Philadelphia | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University - Clinical Research Institute | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania |
| United States | Mayo Clinic Phoenix | Phoenix | Arizona |
| United States | UPMC Cancer Pavillion | Pittsburgh | Pennsylvania |
| United States | Oregon Health and Science University OHSU | Portland | Oregon |
| United States | Providence Portland Medical Center | Portland | Oregon |
| United States | Local Institution - 01023 | Richmond | Virginia |
| United States | Local Institution - 01051 | Rochester | New York |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Local Institution - 01043 | Sacramento | California |
| United States | Siteman Cancer Center | Saint Louis | Missouri |
| United States | Local Institution - 01058 | Salisbury | North Carolina |
| United States | Intermountain Healthcare - LDS Hospital | Salt Lake City | Utah |
| United States | University of Utah - Huntsman Cancer Institute | Salt Lake City | Utah |
| United States | Sam Clinical Research Center | San Antonio | Texas |
| United States | University of California, San Francisco- California | San Francisco | California |
| United States | UCLA Medical Centre-Santa Monica | Santa Monica | California |
| United States | Arizona Cancer Center | Scottsdale | Arizona |
| United States | Fred Hutchinson Cancer Center | Seattle | Washington |
| United States | Local Institution - 01060 | Seattle | Washington |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | Local Institution - 01064 | Sioux Falls | South Dakota |
| United States | Providence Cancer Institute | Southfield | Michigan |
| United States | Local Institution - 01119 | Stanford | California |
| United States | Local Institution - 01055 | Tacoma | Washington |
| United States | H. Lee Moffitt Cancer Center and Research Institute University of South Florida | Tampa | Florida |
| United States | Local Institution - 01033 | Temple | Texas |
| United States | Local Institution - 01021 | Tucson | Arizona |
| United States | Texas Oncology, P.A. - Tyler | Tyler | Texas |
| United States | Local Institution - 01050 | Washington | District of Columbia |
| United States | Local Institution - 01069 | Wauwatosa | Wisconsin |
| United States | Kansas University Medical Center | Westwood | Kansas |
| United States | Cancer Center of Kansas | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States, Austria, Belgium, Canada, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of delayed Adverse Events (AEs) | Up to 15 years from last gene-modified (GM) T cell infusion | ||
| Primary | Persistence of GM T cells | Up to 15 years from last GM T cell infusion | ||
| Primary | Analysis of vector integration sites | Up to 15 years from last GM T cell infusion | ||
| Primary | Incidence of replication-competent lentiviruses | Up to 15 years from last GM T cell infusion | ||
| Primary | 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 | ||
| Primary | 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 | ||
| Primary | Disease status of the primary malignancy | Up to 15 years from last GM T cell infusion | ||
| Primary | Disease Progression: Number of participants who continue to be responders, who have progressed, and who have relapsed will be reported. | Up to 15 years from last GM T cells infusion | ||
| Primary | Disease Relapse: Number of participants who continue to be responders, who have progressed, and who have relapsed will be reported. | Up to 15 years from last GM T cells infusion | ||
| Primary | 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. | Up to 15 years from last GM T cells infusion | ||
| Secondary | Lymphocyte count (B-cell) | 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. | Up to 15 years |
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