Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Sponsor
Celgene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03435796
Collaborator
(none)
191
174
1
221.4
1.1
0
Study Details
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 | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
191 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Actual Study Start Date
:
Jun 19, 2018
Anticipated Primary Completion Date
:
Nov 30, 2036
Anticipated Study Completion Date
:
Nov 30, 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
- 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]
- Disease status of the primary malignancy [Up to 15 years from last GM T cell infusion]
- 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]
- 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]
- 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 Outcome Measures
- Health-related quality of life (HRQoL): Measurement of HRQoL changes as assessed using instruments administered in the parent treatment protocol [Up to approximately 5 years from last GM T cell infusion]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Birmingham | Birmingham | Alabama | United States | 10016 |
| 2 | University of Alabama Birmingham | Birmingham | Alabama | United States | 10016 |
| 3 | Banner MD Anderson Cancer Center | Gilbert | Arizona | United States | 85234 |
| 4 | Mayo Clinic Phoenix | Phoenix | Arizona | United States | 85054 |
| 5 | Arizona Cancer Center | Scottsdale | Arizona | United States | 85258 |
| 6 | City of Hope | Duarte | California | United States | 91010-301 |
| 7 | University of California San Diego Moores Cancer Center | La Jolla | California | United States | 92093 |
| 8 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 9 | Sutter Hematology and Oncology | Sacramento | California | United States | 95816 |
| 10 | University of California, San Francisco- California | San Francisco | California | United States | 94143 |
| 11 | UCLA Medical Centre-Santa Monica | Santa Monica | California | United States | 90095 |
| 12 | Stanford Cancer Center | Stanford | California | United States | 94305 |
| 13 | University of Colorado Cancer Center | Aurora | Colorado | United States | 80045 |
| 14 | Colorado Blood Cancer Institute | Denver | Colorado | United States | 80218 |
| 15 | Yale Cancer Center | New Haven | Connecticut | United States | 06520 |
| 16 | Lombardi Cancer Center - Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
| 17 | The Mayo Clinic - Jacksonville, Davis-E | Jacksonville | Florida | United States | 32224 |
| 18 | The Mayo Clinic - Jacksonville, Davis-E | Jacksonville | Florida | United States | 32224 |
| 19 | Baptist Cancer Center | Miami | Florida | United States | 33176 |
| 20 | Florida Hospital Transplant Institute | Orlando | Florida | United States | 32804 |
| 21 | H. Lee Moffitt Cancer Center and Research Institute University of South Florida | Tampa | Florida | United States | 33612 |
| 22 | Winship Cancer Institute of Emory University | Atlanta | Georgia | United States | 30322 |
| 23 | Northside Hospital, Inc | Atlanta | Georgia | United States | 30342 |
| 24 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
| 25 | University of Chicago Medical Center | Chicago | Illinois | United States | 60637-1447 |
| 26 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 27 | Illinois Cancer Specialists | Niles | Illinois | United States | 60714 |
| 28 | IN Univ Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
| 29 | IN Univ Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
| 30 | Franciscan St. Francis Health - Indiana Blood and Marrow Transplantation (IBMT) | Indianapolis | Indiana | United States | 46237 |
| 31 | Kansas University Medical Center | Westwood | Kansas | United States | 66205 |
| 32 | Cancer Center of Kansas | Wichita | Kansas | United States | 67214 |
| 33 | University of Kentucky | Lexington | Kentucky | United States | 40536 |
| 34 | Norton Cancer Institute Louisville Oncology | Louisville | Kentucky | United States | 40207 |
| 35 | University of Maryland - Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | United States | 21201 |
| 36 | Sidney Kimmel Comp Cancer Center at Johns Hopkins | Baltimore | Maryland | United States | 21231 |
| 37 | National Cancer Institute | Bethesda | Maryland | United States | 20892-1203 |
| 38 | Massachusetts General Hospital / Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02114 |
| 39 | Massachusetts General Hospital / Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02114 |
| 40 | Dana-Farber/Mass General Brigham Cancer Care, Inc | Boston | Massachusetts | United States | 02115 |
| 41 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109 |
| 42 | Karmanos Cancer Center Wayne State University | Detroit | Michigan | United States | 48201 |
| 43 | Providence Cancer Institute | Southfield | Michigan | United States | 48075 |
| 44 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 45 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 46 | Siteman Cancer Center | Saint Louis | Missouri | United States | 63110 |
| 47 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-6840 |
| 48 | Regional Cancer Care Associates LLC | East Brunswick | New Jersey | United States | 08816 |
| 49 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 50 | Morristown Memorial Hosp | Morristown | New Jersey | United States | 07962 |
| 51 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 52 | New York Oncology Hematology P.C. | Albany | New York | United States | 12206 |
| 53 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 54 | NYU Langone Laura and Isaac Perlmutter Cancer Center | New York | New York | United States | 10016 |
| 55 | Weill Cornell Medicine / New York Presbyterian Hospital | New York | New York | United States | 10021 |
| 56 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
| 57 | Columbia University Medical Center/New York-Presbyterian Hospital | New York | New York | United States | 10032 |
| 58 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 59 | University of Rochester James P. Wilmot Cancer Center | Rochester | New York | United States | 14642 |
| 60 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
| 61 | Duke University Medical Center | Durham | North Carolina | United States | 27705 |
| 62 | Oncology Hematology Care, Inc. | Cincinnati | Ohio | United States | 45242 |
| 63 | University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106-5000 |
| 64 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 65 | University of Oklahoma Peggy and Charles Stephenson Cancer Center | Oklahoma City | Oklahoma | United States | 73104 |
| 66 | Willamette Valley Cancer Institute | Eugene | Oregon | United States | 97401 |
| 67 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
| 68 | Oregon Health and Science University OHSU | Portland | Oregon | United States | 97239 |
| 69 | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 70 | University of Pennsylvania Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | United States | 19104 |
| 71 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 72 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 73 | UPMC Cancer Pavillion | Pittsburgh | Pennsylvania | United States | 15232 |
| 74 | Hematology and Oncology Associates of SC, LLC | Greenville | South Carolina | United States | 29615 |
| 75 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
| 76 | Sarah Cannon Research Inst | Nashville | Tennessee | United States | 37203 |
| 77 | Texas Oncology | Dallas | Texas | United States | 75230 |
| 78 | Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | United States | 75246 |
| 79 | UT Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 80 | University of Texas- MD Anderson | Houston | Texas | United States | 77030 |
| 81 | SAM Clinical Research Center | San Antonio | Texas | United States | 78229 |
| 82 | Baylor Scott and White Health | Temple | Texas | United States | 76508 |
| 83 | Texas Oncology, P.A. - Tyler | Tyler | Texas | United States | 75702 |
| 84 | University of Utah - Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112 |
| 85 | Intermountain Healthcare - LDS Hospital | Salt Lake City | Utah | United States | 84143 |
| 86 | University of Virginia Health System | Charlottesville | Virginia | United States | 22903 |
| 87 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23502 |
| 88 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
| 89 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
| 90 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
| 91 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109 |
| 92 | Northwest Medical Specialties PLLC | Tacoma | Washington | United States | 98405 |
| 93 | University Of Wisconsin | Madison | Wisconsin | United States | 53705 |
| 94 | University Of Wisconsin | Madison | Wisconsin | United States | 53705 |
| 95 | Froedtert Hospital BMT Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226-3522 |
| 96 | Froedtert Hospital BMT Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226-3522 |
| 97 | Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien | Wien | Austria | 1090 | |
| 98 | Local Institution - 05351 | Gent | Belgium | 9000 | |
| 99 | UZ Gent | Gent | Belgium | 9000 | |
| 100 | University Hospital Leuven | Leuven | Belgium | 3000 | |
| 101 | University of Calgary | Calgary | Alberta | Canada | T2N 2T9 |
| 102 | Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 103 | Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 1C3 |
| 104 | Princess Margaret Cancer Centre | Toronto | Ontario | Canada | M5G 2M9 |
| 105 | CIUSSS de l'Est-de-l'Ile-de-Montreal | Montreal | Quebec | Canada | H1T 2M4 |
| 106 | Helsinki University Central Hospital (HUCH) | Helsinki | Finland | 00290 | |
| 107 | CHRU de Lille France | Lille Cedex | France | 59037 | |
| 108 | Institute for Pediatric Hematology - Oncology, Leon Berard Cancer Center | Lyon | France | 69008 | |
| 109 | Institut Paoli-Calmettes | Marseille Cedex 9 | France | 13009 | |
| 110 | Hopitaux de La Timone | Marseille Cedex 9 | France | 13385 | |
| 111 | CHU Montpellier - Hôpital Saint Eloi | Montpellier CEDEX 5 | France | 34295 | |
| 112 | CHU Hotel Dieu | Nantes Cedex 01 | France | 44093 | |
| 113 | Hopital Saint Louis | Paris | France | 75010 | |
| 114 | Hospital Saint Louis | Paris | France | 75475 | |
| 115 | Hopital Robert Debre | Paris | France | 75935 | |
| 116 | Centre Hospitalier Lyon-Sud | Pierre-Benite CEDEX | France | 69495 | |
| 117 | CHU La Miletrie | Poitiers Cedex | France | 86021 | |
| 118 | Institut Universitaire du Cancer de Toulouse - Oncopole | Toulouse CEDEX 9 | France | 31059 | |
| 119 | Gustave Roussy | Villejuif | France | 94805 | |
| 120 | Robert-Rössle-Klinik im HELIOS Klinikum Berlin-Buch Klinik für Hämatologie, Onkologie u. Tumorimmuno | Berlin | Germany | 13125 | |
| 121 | Charite -Universitätsmedizin Berlin | Berlin | Germany | 13353 | |
| 122 | Universitatsklinikum Carl Gustav Carus an der TU Dresden | Dresden | Germany | D-01307 | |
| 123 | Hematology Oncology and clinical immunology / Heinrich-Heine-University | Dusseldorf | Germany | 40225 | |
| 124 | Medizinische Klinik II ZIM,Hamatologie Onkologie Uniklinik Frankfurt | Frankfurt | Germany | 60590 | |
| 125 | Universitaetsklinikum Hamburg-Eppendorf | Hamburg | Germany | 20426 | |
| 126 | Universitatsklinikum Heidelberg | Heidelberg | Germany | 69120 | |
| 127 | Kinikum der Universitaeat zu Koeln | Koeln | Germany | 50937 | |
| 128 | Universitaetsklinikum Muenster | Muenster | Germany | 48149 | |
| 129 | LMU Klinikum der Universität | München | Germany | 81377 | |
| 130 | Universitaetsklinikum Tuebingen | Tuebingen | Germany | 72076 | |
| 131 | University Hospital of Ulm | Ulm | Germany | 89081 | |
| 132 | Local Institution - 03501 | Würzburg | Germany | 97080 | |
| 133 | Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II | Würzburg | Germany | 97080 | |
| 134 | Ospedali Riuniti di Ancona | Ancona | Italy | 60126 | |
| 135 | Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi | Bologna | Italy | 40138 | |
| 136 | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Italy | 20133 | |
| 137 | Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM) | Monza | Italy | 20900 | |
| 138 | Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale | Napoli | Italy | 80131 | |
| 139 | Universita La Sapienza | Roma | Italy | 00168 | |
| 140 | Ospedale Pediatrico Bambino Gesu | Rome | Italy | 00165 | |
| 141 | Istituto Clinico Humanitas | Rozzano (MI) | Italy | 20089 | |
| 142 | Azienda Ospedaliera Citta della Salute e della Scienza di Torino | Torino | Italy | 01012 | |
| 143 | Azienda Sanitaria Ospedaliera San Giovanni Battista Molinette | Turin | Italy | 10126 | |
| 144 | Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital | Bunkyo-ku | Japan | 113-8677 | |
| 145 | National Cancer Center Hospital | Chuo-ku | Japan | 104-0045 | |
| 146 | Kyushu University Hospital | Fukuoka | Japan | 812-8582 | |
| 147 | Tokai University Hospital | Isehara City, Kanagawa | Japan | 259-1193 | |
| 148 | Toranomon Hospital | Minato-ku | Japan | 105-8470 | |
| 149 | Local Institution - 13203 | Osaka | Japan | 545-8586 | |
| 150 | Osaka City University Hospital | Osaka | Japan | 545-8586 | |
| 151 | Hokkaido University Hospital | Sapporo, Hokkaidô | Japan | 060-8648 | |
| 152 | Japan Red Cross Medical Center | Shibuya-ku | Japan | 150-8935 | |
| 153 | Jichi Medical University Hospital | Shimotsuke | Japan | 329-0498 | |
| 154 | Tokyo Women's Medical University Hospital | Shinjuku City | Japan | 162-8666 | |
| 155 | Vrije Universiteit Medisch Centrum (VUMC) | Amsterdam | Netherlands | 1081 HV | |
| 156 | Erasmus Medical Center - Daniel den Hoed | Rotterdam | Netherlands | 3075 EA | |
| 157 | Princess Maxima Center for Pediatric Oncology | Utrecht | Netherlands | 3584 CS | |
| 158 | Oslo Universitetssykehus | Oslo | Norway | 0310 | |
| 159 | Hospital Universitario Vall D hebron | Barcelona | Spain | 08035 | |
| 160 | Hospital Universitari Germans Trias i Pujol ICO Badalona | Barcelona | Spain | 08916 | |
| 161 | Institut Clinic de Nefrologia i Urologia - Hospital Clinic i Provincial de Barcelona | Barcelona | Spain | 8036 | |
| 162 | Hospital San Joan de Deu Barcelona | Esplugues de Llobregat | Spain | 08950 | |
| 163 | Hospital Infantil Universitario Nino Jesus | Madrid | Spain | 28009 | |
| 164 | Hospital 12 de Octubre | Madrid | Spain | 28041 | |
| 165 | Clinica Universidad de Navarra | Pamplona | Spain | 31008 | |
| 166 | Universitario de Salamanca - Hospital Clinico | Salamanca | Spain | 37007 | |
| 167 | Hospital Virgen del Rocio | Sevilla | Spain | 41013 | |
| 168 | Karolinska University Hospital Huddinge | Stockholm | Sweden | 14186 | |
| 169 | Inselspital Bern | Bern | Switzerland | 3010 | |
| 170 | The Leeds Teaching Hospitals NHS Trust - St James's University Hospital | Leeds | United Kingdom | LS9 7TF | |
| 171 | Kings College Hospital | London | United Kingdom | SE5 9RS | |
| 172 | UCL Cancer Institute | London | United Kingdom | WC1E 6BT | |
| 173 | Christie Hospital NHS Trust | Manchester Withington | United Kingdom | M20 4BX | |
| 174 | Somers Cancer Research Building | Shirley Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT03435796
Other Study ID Numbers:
- GC-LTFU-001
- U1111-1206-8250
- 2017-001465-24
First Posted:
Feb 19, 2018
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Celgene