- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03435796
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
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 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: First line of the email MUST contain NCT # and Site #.
Study Contact Backup
- Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Phone Number: 855-907-3286
- Email: Clinical.Trials@bms.com
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3000
- Recruiting
- Peter Maccallum Cancer Centre
-
Contact:
- Simon Harrison, Site 16001
- Phone Number: +61424189068
-
Melbourne, Victoria, Australia, 3004
- Recruiting
- The Alfred Hospital
-
Contact:
- Shafqat Inam, Site 16004
- Phone Number: 0472591197
-
-
Western Australia
-
Murdoch, Western Australia, Australia, 6150
- Recruiting
- Fiona Stanley Hospital
-
Contact:
- Stephanie Lam, Site 16006
- Phone Number: +61861523788
-
-
-
-
-
Vienna, Austria, 1090
- Recruiting
- Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien
-
Contact:
- Ulrich Jaeger, Site 12101
- Phone Number: 43 140400-44100
-
-
-
-
-
Anderlecht, Belgium, 1070
- Recruiting
- Jules Bordet Institut
-
Contact:
- Marie Vercruyssen, Site 05202
- Phone Number: 02 5413847
-
Brussels, Belgium, 1090
- Recruiting
- Universitair Ziekenhuis Brussel
-
Contact:
- Ann De Becker, Site 05203
- Phone Number: 0000000000
-
Ghent, Belgium, 9000
- Recruiting
- UZ Gent
-
Contact:
- Fritz Offner, Site 05351
- Phone Number: +32(0)93328770
-
Ghent, Belgium, 9000
- Withdrawn
- Local Institution - 05200
-
Leuven, Belgium, 3000
- Recruiting
- University Hospital Leuven
-
Contact:
- Michel Delforge, Site 05201
- Phone Number: +3216346880
-
Leuven, Belgium, B-3000
- Withdrawn
- Local Institution - UNK 2
-
-
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 2T9
- Recruiting
- University of Calgary
-
Contact:
- Nizar Bahlis, Site 02302
- Phone Number: 4039441880
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Withdrawn
- Local Institution - 02802
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V 1C3
- Withdrawn
- Local Institution - 02801
-
Toronto, Ontario, Canada, M5G 2M9
- Recruiting
- Princess Margaret Cancer Centre
-
Contact:
- Christine Chen, Site 02301
- Phone Number: 4169464501
-
-
Quebec
-
Montreal, Quebec, Canada, H1T 2M4
- Recruiting
- CIUSSS de l'Est-de-l'Île-de-Montréal
-
Contact:
- Isabelle Fleury, Site 02800
- Phone Number: 5142523404
-
-
-
-
-
Helsinki, Finland, 00290
- Recruiting
- Helsinki University Central Hospital (HUCH)
-
Contact:
- Sirpa Leppa, Site 11551
- Phone Number: 358504270820
-
-
-
-
-
Creteil-Paris, France, 94000
- Recruiting
- Hôpital Henri Mondor
-
Contact:
- Karim BELHADJ-MERZOUG, Site 09211
- Phone Number: +33149812163
-
Lille, France, 59037
- Recruiting
- CHRU de Lille France
-
Contact:
- Ibrahim YAKOUB-AGHA, Site 09202
- Phone Number: +33320445551
-
Lyon, France, 69008
- Withdrawn
- Local Institution - 09601
-
Marseille, France, 13009
- Completed
- Local Institution - 09400
-
Marseille, France, 13385
- Withdrawn
- Local Institution - 09602
-
Montpellier, France, 34295
- Recruiting
- CHU Montpellier - Hôpital Saint Eloi
-
Contact:
- Guillaume Cartron, Site 09206
- Phone Number: +33675926918
-
Nantes, France, 44093
- Recruiting
- CHU Hotel Dieu
-
Contact:
- Philippe Moreau, Site 09401
- Phone Number: 33240083271
-
Paris, France, 75010
- Recruiting
- Hôpital Saint Louis
-
Contact:
- Bertrand Arnulf, Site 09204
- Phone Number: 33142499472
-
Paris, France, 75475
- Recruiting
- Hospital Saint Louis
-
Contact:
- Catherine Thieblemont, Site 09207
- Phone Number: 33142499236
-
Paris, France, 75935
- Withdrawn
- Local Institution - 09600
-
Pessac, France, 33600
- Recruiting
- Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Haut-Leveque
-
Contact:
- Cyrille Hulin, Site 09210
- Phone Number: 33557656511
-
Pierre-Bénite, France, 69495
- Recruiting
- Centre Hospitalier Lyon-Sud
-
Contact:
- Herve Ghesquieres, Site 09201
- Phone Number: 33478864348
-
Poitiers, France, 86021
- Recruiting
- CHU La Milétrie
-
Contact:
- xavier leleu, Site 09203
- Phone Number: +33 982602178
-
Rennes, France, 35000
- Recruiting
- Hopital Sud
-
Contact:
- Alain Lescoat, Site 09212
- Phone Number: 33299284321
-
Toulouse, France, 31059
- Recruiting
- Institut Universitaire du Cancer de Toulouse - Oncopole
-
Contact:
- Aurore Perrot, Site 09205
- Phone Number: 0531156184
-
Villejuif, France, 94805
- Recruiting
- Gustave Roussy
-
Contact:
- Vincent Ribrag, Site 09402
- Phone Number: 33142114507
-
-
-
-
-
Berlin, Germany, 13125
- Recruiting
- Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. Tumorimmuno
-
Contact:
- Bertram Glass, Site 03451
- Phone Number: +0049551396047 00000
-
Berlin, Germany, 13353
- Not yet recruiting
- Local Institution - 03155
-
Contact:
- Site 03155
-
Cologne, Germany, 50937
- Recruiting
- Kinikum der Universitaeat zu Koeln
-
Contact:
- Peter Borchmann, Site 03151
- Phone Number: 4922147898888
-
Dresden, Germany, D-01307
- Recruiting
- Universitätsklinikum Carl Gustav Carus an der TU Dresden
-
Contact:
- Martin Wermke, Site 03152
- Phone Number: +493514587566
-
Düsseldorf, Germany, 40225
- Withdrawn
- Local Institution - 03513
-
Frankfurt, Germany, 60590
- Withdrawn
- Local Institution - 03500
-
Hamburg, Germany, 20426
- Recruiting
- Universitaetsklinikum Hamburg-Eppendorf
-
Contact:
- Francis Ayuk, Site 03452
-
Heidelberg, Germany, 69120
- Recruiting
- Universitätsklinikum Heidelberg
-
Contact:
- Hartmut Goldschmidt, Site 03502
- Phone Number: +496221568003
-
München, Germany, 81377
- Recruiting
- LMU Klinikum der Universität
-
Contact:
- Marion Subklewe, Site 03154
- Phone Number: +4989440073133
-
Münster, Germany, 48149
- Withdrawn
- Local Institution - 03454
-
Tübingen, Germany, 72076
- Completed
- Local Institution - 03503
-
Ulm, Germany, 89081
- Recruiting
- University Hospital of Ulm
-
Contact:
- Andreas Viardot, Site 03153
- Phone Number: +49-73150045539
-
Würzburg, Germany, 97080
- Recruiting
- Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II
-
Contact:
- Hermann Einsele, Site 03501
- Phone Number: +4994120140202
-
-
-
-
-
Jerusalem, Israel, 9112001
- Recruiting
- Hadassah Medical Center - Ein Kerem Hospital
-
Contact:
- Eyal Lebel, Site 18002
- Phone Number: 972-50-5172304
-
Tel Aviv, Israel, 6423906
- Recruiting
- Tel-Aviv Sourasky Medical Center
-
Contact:
- Ron Ram, Site 18005
- Phone Number: 97236974138
-
Tel Litwinsky, Israel, 5262100
- Recruiting
- The Chaim Sheba Medical Center
-
Contact:
- Hila Magen, Site 18003
- Phone Number: 972504065462
-
-
Southern District
-
Beersheba, Southern District, Israel, 85025
- Recruiting
- Soroka Medical Center
-
Contact:
- Uri Greenbaum, Site 18006
- Phone Number: +972584046264
-
-
-
-
-
Ancona, Italy, 60126
- Recruiting
- Ospedali Riuniti di Ancona
-
Contact:
- Federico Lussana, Site 07602
-
Bologna, Italy, 40138
- Recruiting
- Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi
-
Contact:
- Michele Cavo, Site 07601
- Phone Number: +390516363680
-
Milan, Italy, 20133
- Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori
-
Contact:
- Paolo Corradini, Site 07402
- Phone Number: +00390223903146 0000
-
Monza, Italy, 20900
- Recruiting
- Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM)
-
Contact:
- Adriana Balduzzi, Site 07301
-
Naples, Italy, 80131
- Recruiting
- Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione Giovanni Pascale
-
Contact:
- Antonio Pinto, Site 07303
- Phone Number: 390815903382
-
Roma, Italy, 00168
- Withdrawn
- Local Institution - 07500
-
Rome, Italy, 00165
- Recruiting
- Ospedale Pediatrico Bambino Gesù
-
Contact:
- Franco Locatelli, Site 07300
- Phone Number: 390668593697
-
Rozzano (MI), Italy, 20089
- Recruiting
- Istituto Clinico Humanitas
-
Contact:
- Armando Santoro, Site 07501
- Phone Number: +00390282244080 0000
-
Torino, Italy, 01012
- Completed
- Local Institution - 07610
-
Turin, Italy, 10126
- Recruiting
- Azienda Sanitaria Ospedaliera San Giovanni Battista Molinette
-
Contact:
- Barbara Botto, Site 07401
- Phone Number: 3479131037
-
-
-
-
-
Bunkyō City, Japan, 113-8677
- Completed
- Local Institution - 13202
-
Fukuoka, Japan, 812-8582
- Recruiting
- Kyushu University Hospital
-
Contact:
- Koji Kato, Site 13805
- Phone Number: 81-92-642-5155
-
Isehara City, Kanagawa, Japan, 259-1193
- Recruiting
- Tokai University Hospital
-
Contact:
- Yoshiaki Ogawa, Site 13803
- Phone Number: 8181463931121
-
Kyoto, Japan, 602-8566
- Recruiting
- University Hospital,Kyoto Prefectural University of Medicine
-
Contact:
- Junya Kuroda, Site 13001
- Phone Number: 81752515740
-
Nagoya, Japan, 467-8602
- Recruiting
- Nagoya City University Hospital
-
Contact:
- Shinsuke Iida, Site 13807
- Phone Number: 81528515511
-
Osaka, Japan, 545-8586
- Recruiting
- Osaka Metropolitan University Hospital
-
Contact:
- Yasuhiro Nakashima, Site 13203
- Phone Number: 81666452121
-
Shibuya-ku, Japan, 150-8935
- Recruiting
- Japan Red Cross Medical Center
-
Contact:
- Kenshi Suzuki, Site 13801
- Phone Number: 81334000104
-
Shinjuku, Japan, 162-8666
- Withdrawn
- Local Institution - 13804
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 0608648
- Recruiting
- Hokkaido University Hospital
-
Contact:
- Hideki Goto, Site 13806
- Phone Number: 81117067214
-
-
Tochigi
-
Shimotsuke, Tochigi, Japan, 329-0498
- Recruiting
- Jichi Medical University Hospital
-
Contact:
- Yoshinobu Kanda, Site 13802
- Phone Number: +81-285-58-7195
-
-
Tokyo
-
Chuo-ku, Tokyo, Japan, 1040045
- Recruiting
- National Cancer Center Hospital
-
Contact:
- Koji Izutsu, Site 13601
- Phone Number: 81 335422511
-
Minato-ku, Tokyo, Japan, 105-8470
- Recruiting
- Toranomon Hospital
-
Contact:
- Go Yamamoto, Site 13602
- Phone Number: 81335881111
-
-
-
-
-
Amsterdam, Netherlands, 1081 HV
- Completed
- Local Institution - 04650
-
Rotterdam, Netherlands, 3075 EA
- Recruiting
- Erasmus Medical Center - Daniel den Hoed
-
Contact:
- Pim Mutsaers, Site 04301
-
Utrecht, Netherlands, 3584 CS
- Withdrawn
- Local Institution - 04400
-
-
-
-
-
Oslo, Norway, 0310
- Recruiting
- Oslo universitetssykehus
-
Contact:
- Ingerid Abrahamsen, Site 14001
- Phone Number: +4723070460
-
-
-
-
-
Gdansk, Poland, 80-214
- Recruiting
- Uniwersyteckie Centrum Kliniczne
-
Contact:
- Jan Zaucha, Site 22006
- Phone Number: +48585844340
-
Lublin, Poland, 20-090
- Recruiting
- St Johns Cancer Centre in Lublin
-
Contact:
- Wojciech Legiec, Site 22004
- Phone Number: 48502074194
-
Warsaw, Poland, 02-776
- Recruiting
- Instytut Hematologii i Transfuzjologii
-
Contact:
- Ewa Lech-Maranda, Site 22003
- Phone Number: 48223496176
-
-
-
-
-
Bucharest, Romania, 22328
- Recruiting
- Institutul Clinic Fundeni
-
Contact:
- Alina Tanase, Site 23001
-
-
-
-
-
Seoul, South Korea, 6351
- Recruiting
- Samsung Medical Center
-
Contact:
- Kihyun Kim, Site 17001
- Phone Number: +821099333456
-
Seoul, South Korea, 6591
- Recruiting
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Contact:
- Chang Ki Min, Site 17002
- Phone Number: 82-20-2258-6053
-
Seoul, South Korea, 5505
- Recruiting
- Asan Medical Center (AMC)
-
Contact:
- Dok Hyun Yoon, Site 17003
- Phone Number: 82230105940
-
-
-
-
-
Barcelona, Spain, 08916
- Recruiting
- Hospital Universitari Germans Trias i Pujol ICO Badalona
-
Contact:
- Albert Oriol Rocafiguera, Site 08702
- Phone Number: 34934978987
-
Barcelona, Spain, 08035
- Recruiting
- Hospital Universitario Vall d Hebron
-
Contact:
- Pere Barba Suñol, Site 08451
- Phone Number: 349348930004897
-
Barcelona, Spain, 8036
- Recruiting
- Institut Clinic de Nefrologia i Urologia - Hospital Clinic i Provincial de Barcelona
-
Contact:
- Armando Lopez Guillermo, Site 08600
- Phone Number: +34932275475
-
Córdoba, Spain, 14004
- Recruiting
- Hospital Universitario Reina Sofía
-
Contact:
- Alejandro Escudero Contreras, Site 08708
-
Esplugues de Llobregat, Spain, 08950
- Recruiting
- Hospital San Joan de Deu Barcelona
-
Contact:
- Susana Rives, Site 08251
-
Madrid, Spain, 28041
- Recruiting
- Hospital 12 de Octubre
-
Contact:
- Joaquin Martinez Lopez, Site 08601
- Phone Number: 34913908525
-
Madrid, Spain, 28009
- Recruiting
- Hospital Infantil Universitario Nino Jesus
-
Contact:
- Alba Rubio, Site 08252
- Phone Number: 34915035900
-
Málaga, Spain, 29010
- Recruiting
- Hospital Regional Universitario de Malaga (Antiguo Carlos Haya)
-
Contact:
- Antonio Fernandez Nebro, Site 08705
- Phone Number: +34951290360
-
Pamplona, Spain, 31008
- Recruiting
- Clinica Universidad de Navarra
-
Contact:
- Paula Rodriguez Otero, Site 08701
- Phone Number: +0034948254000 0 000
-
Salamanca, Spain, 37007
- Recruiting
- Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
-
Contact:
- Maria Victoria Mateos Manteca, Site 08751
- Phone Number: 34923291100
-
Seville, Spain, 41013
- Recruiting
- Hospital Virgen del Rocío
-
Contact:
- Delgado Javier, Site 08253
- Phone Number: +955013077
-
-
-
-
-
Stockholm, Sweden, 14186
- Recruiting
- Karolinska University Hospital Huddinge
-
Contact:
- Stephan Mielke, Site 15001
- Phone Number: 46 72 595 59 87
-
-
-
-
-
Bern, Switzerland, 3010
- Recruiting
- Inselspital Bern
-
Contact:
- Urban Novak, Site 06251
- Phone Number: +41316324114
-
-
-
-
-
Leeds, United Kingdom, LS9 7TF
- Withdrawn
- Local Institution - 10850
-
London, United Kingdom, SE5 9RS
- Recruiting
- Kings College Hospital
-
Contact:
- Reuben BEnjamin, Site 10851
- Phone Number: 02032991248
-
London, United Kingdom, WC1E 6BT
- Recruiting
- UCL Cancer Institute
-
Contact:
- Claire Roddie, Site 10501
- Phone Number: +4402034479911 (0)
-
Manchester Withington, United Kingdom, M20 4BX
- Recruiting
- Christie Hospital Nhs Trust
-
Contact:
- Kim Linton, Site 10502
- Phone Number: 0161 918 7227
-
Shirley Southampton, United Kingdom, SO16 6YD
- Recruiting
- Somers Cancer Research Building
-
Contact:
- Andrew Davies, Site 10500
- Phone Number: +442380795246 00 00
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 10016
- Recruiting
- University of Alabama Birmingham
-
Contact:
- Luciano Costa, Site 01171
- Phone Number: 205-934-9695
-
-
Arizona
-
Gilbert, Arizona, United States, 85234
- Recruiting
- Banner MD Anderson Cancer Center
-
Contact:
- Rajneesh Nath, Site 01049
- Phone Number: 480-256-3223
-
Phoenix, Arizona, United States, 85054
- Recruiting
- Mayo Clinic Phoenix
-
Contact:
- Jeremy Larsen, Site 01200
-
Scottsdale, Arizona, United States, 85258
- Recruiting
- Arizona Cancer Center
-
Contact:
- Adrienne Briggs, Site 01039
- Phone Number: 520-626-3191
-
Tucson, Arizona, United States, 85724
- Withdrawn
- Local Institution - 01021
-
-
California
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope
-
Contact:
- Tanya Siddiqi, Site 01011
- Phone Number: 626-256-4673
-
La Jolla, California, United States, 92093
- Recruiting
- University of California San Diego Moores Cancer Center
-
Contact:
- Thomas Kipps, Site 01019
- Phone Number: 858-822-6135
-
Los Angeles, California, United States, 90048
- Withdrawn
- Local Institution - 01206
-
Sacramento, California, United States, 95816
- Withdrawn
- Local Institution - 01043
-
San Francisco, California, United States, 94143
- Recruiting
- University of California, San Francisco- California
-
Contact:
- Charalambos Andreadis, Site 01108
- Phone Number: 415-238-1909
-
Santa Monica, California, United States, 90095
- Recruiting
- UCLA Medical Centre-Santa Monica
-
Contact:
- Sarah Larson, Site 01184
- Phone Number: 310-829-5471
-
Stanford, California, United States, 94305
- Recruiting
- Stanford Cancer Center
-
Contact:
- Michaela Liedtke, Site 01119
- Phone Number: 650-498-6000
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado Cancer Center
-
Contact:
- Manali Kamdar, Site 01208
- Phone Number: 720-848-0752
-
Denver, Colorado, United States, 80218
- Recruiting
- Colorado Blood Cancer Institute
-
Contact:
- Tara Gregory, Site 01212
- Phone Number: 720-754-4800
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Recruiting
- Yale Cancer Center
-
Contact:
- Iris Isufi, Site 01059
- Phone Number: 203-688-4242
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20007
- Withdrawn
- Local Institution - 01050
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Recruiting
- The Mayo Clinic - Jacksonville, Davis-E
-
Contact:
- Sikander Ailawadhi, Site 01201
- Phone Number: 904-953-0853
-
Miami, Florida, United States, 33176
- Recruiting
- Baptist Cancer Center
-
Contact:
- Yuliya Linhares, Site 01047
- Phone Number: 786-596-2000
-
Orlando, Florida, United States, 32804
- Completed
- Local Institution - 01035
-
Tampa, Florida, United States, 33612
- Recruiting
- H. Lee Moffitt Cancer Center and Research Institute University of South Florida
-
Contact:
- Melissa Alsina, Site 01153
- Phone Number: 813-745-7202
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Winship Cancer Institute of Emory University
-
Contact:
- Sagar Lonial, Site 01103
- Phone Number: 404-778-1900
-
Atlanta, Georgia, United States, 30342
- Recruiting
- Northside Hospital, Inc
-
Contact:
- Scott Solomon, Site 01207
- Phone Number: 404-255-1930
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern Memorial Hospital
-
Contact:
- Reem Karmali, Site 01014
- Phone Number: 312-695-0990
-
Chicago, Illinois, United States, 60637-1447
- Recruiting
- University of Chicago Medical Center
-
Contact:
- Peter Riedell, Site 01018
- Phone Number: 773-702-8412
-
Maywood, Illinois, United States, 60153
- Withdrawn
- Local Institution - 01040
-
Niles, Illinois, United States, 60714
- Withdrawn
- Local Institution - 01063
-
-
Indiana
-
Indianapolis, Indiana, United States, 46237
- Recruiting
- Franciscan Health Indianapolis
-
Contact:
- Anand Tandra, Site 01217
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- IN Univ Simon Cancer Center
-
Contact:
- Rafat Abonour, Site 01161
- Phone Number: 317-690-1577
-
Indianapolis, Indiana, United States, 46237
- Completed
- Local Institution - 01020
-
-
Kansas
-
Westwood, Kansas, United States, 66205
- Recruiting
- Kansas University Medical Center
-
Contact:
- Al-Ola Abdallah, Site 01174
- Phone Number: 918-261-6196
-
Wichita, Kansas, United States, 67214
- Recruiting
- Cancer Center of Kansas
-
Contact:
- Bassam Mattar, Site 01031
- Phone Number: 316-262-4467
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- Recruiting
- University of Kentucky
-
Contact:
- Chaitanya Iragavarapu, Site 01046
-
Louisville, Kentucky, United States, 40207
- Recruiting
- Norton Cancer Institute Louisville Oncology
-
Contact:
- Don Stevens, Site 01032
- Phone Number: 502-899-3366
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Withdrawn
- Local Institution - 01026
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland - Greenebaum Comprehensive Cancer Center
-
Contact:
- Mehmet Kocoglu, Site 01164
- Phone Number: 501-526-6990
-
Baltimore, Maryland, United States, 21231
- Recruiting
- Sidney Kimmel Comp Cancer Center at Johns Hopkins
-
Contact:
- Syed Abbas Ali, Site 01017
- Phone Number: 443-287-7104
-
Bethesda, Maryland, United States, 20892-1203
- Recruiting
- National Cancer Institute
-
Contact:
- James Kochenderfer, Site 01114
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital / Dana-Farber Cancer Institute
-
Contact:
- Jeremy Abramson, Site 01012
- Phone Number: 617-571-3037
-
Boston, Massachusetts, United States, 02114
- Withdrawn
- Local Institution - 01107
-
Boston, Massachusetts, United States, 02115
- Withdrawn
- Local Institution - 01106
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan Comprehensive Cancer Center
-
Contact:
- Monalisa Ghosh, Site 01024
- Phone Number: 734-936-4000
-
Detroit, Michigan, United States, 48201
- Recruiting
- Karmanos Cancer Center Wayne State University
-
Contact:
- Abhinav Deol, Site 01025
- Phone Number: 313-576-8093
-
Southfield, Michigan, United States, 48075
- Recruiting
- Providence Cancer Institute
-
Contact:
- Leo Reap, Site 01056
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- M Health Fairview University of Minnesota Medical Center - East Bank
-
Contact:
- Veronika Bachanova, Site 01112
- Phone Number: 612-625-5469
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
-
Contact:
- Yi Lin, Site 01105
-
-
Missouri
-
St Louis, Missouri, United States, 63110
- Recruiting
- Siteman Cancer Center
-
Contact:
- Ravi Vij, Site 01176
- Phone Number: 314-409-4144
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198-6840
- Recruiting
- University of Nebraska Medical Center
-
Contact:
- Matthew Lunning, Site 01015
- Phone Number: 402-559-7164
-
-
New Jersey
-
East Brunswick, New Jersey, United States, 08816
- Completed
- Local Institution - 01030
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- Hackensack University Medical Center
-
Contact:
- David Siegel, Site 01102
- Phone Number: 201-996-5900
-
Morristown, New Jersey, United States, 07962
- Recruiting
- Morristown Memorial Hosp
-
Contact:
- Mohamad Cherry, Site 01027
- Phone Number: 973-971-7906
-
New Brunswick, New Jersey, United States, 08903
- Withdrawn
- Local Institution - 01053
-
-
New York
-
Albany, New York, United States, 12206
- Recruiting
- New York Oncology Hematology P.C.
-
Contact:
- Courtney Bellomo, Site 01041
-
Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
-
Contact:
- Francisco Hernandez-Ilizaliturri, Site 01111
- Phone Number: 716-845-3099
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Maria Palomba, Site 01177
- Phone Number: 212-639-7186
-
New York, New York, United States, 10029
- Recruiting
- Icahn School of Medicine at Mount Sinai
-
Contact:
- Sundar Jagannath, Site 01109
- Phone Number: 212-241-7873
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Medical Center/New York-Presbyterian Hospital
-
Contact:
- Ran Reshef, Site 01209
- Phone Number: 212-342-0530
-
New York, New York, United States, 10021
- Recruiting
- Weill Cornell Medicine / New York Presbyterian Hospital
-
Contact:
- Roger Niles Pearse, Site 01198
- Phone Number: 212-746-2956
-
New York, New York, United States, 10016
- Withdrawn
- Local Institution - 01066
-
New York, New York, United States, 10016
- Recruiting
- New York University - Langone Medical Center - The Center for Musculoskeletal Care
-
Contact:
- Amit Saxena, Site 01070
- Phone Number: 646-501-7400
-
Rochester, New York, United States, 14642
- Withdrawn
- Local Institution - 01051
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- The University of North Carolina at Chapel Hill
-
Contact:
- Saira Sheikh, Site 01071
- Phone Number: 919-966-0545
-
Charlotte, North Carolina, United States, 28204
- Recruiting
- Levine Cancer Institute
-
Contact:
- Bei Hu, Site 01204
- Phone Number: 980-442-5231
-
Durham, North Carolina, United States, 27705
- Recruiting
- Duke University Medical Center
-
Contact:
- Taewoong Choi, Site 01175
-
Salisbury, North Carolina, United States, 28147
- Recruiting
- Novant Health
-
Contact:
- Alan Skarbnik, Site 01058
- Phone Number: 347-266-6406
-
-
Ohio
-
Cincinnati, Ohio, United States, 45242
- Recruiting
- Oncology Hematology Care, Inc.
-
Contact:
- James Essell, Site 01037
- Phone Number: 513-686-5482
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic Foundation
-
Contact:
- Brian Hill, Site 01062
- Phone Number: 216-445-9451
-
Cleveland, Ohio, United States, 44106-5000
- Recruiting
- University Hospitals Of Cleveland
-
Contact:
- Leland Metheny, Site 01042
- Phone Number: 216-844-0139
-
Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute
-
Contact:
- Srinivas Devarakonda, Site 01074
- Phone Number: 570-423-0522
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Peggy and Charles Stephenson Cancer Center
-
Contact:
- Adam Asch, Site 01038
- Phone Number: 405-271-4022
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Recruiting
- Willamette Valley Cancer Institute
-
Contact:
- Jeff Sharman, Site 01052
- Phone Number: 541-683-5001
-
Portland, Oregon, United States, 97213
- Recruiting
- Providence Portland Medical Center
-
Contact:
- Stacy Lewis, Site 01028
- Phone Number: 503-215-5696
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health and Science University OHSU
-
Contact:
- Richard Maziarz, Site 01022
- Phone Number: 503-231-2498
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19111
- Recruiting
- Fox Chase Cancer Center
-
Contact:
- Asya Varshavsky-Yanovsky, Site 01172
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania Perelman Center for Advanced Medicine
-
Contact:
- Stephen Schuster, Site 01016
- Phone Number: 215-614-1846
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Thomas Jefferson University - Clinical Research Institute
-
Contact:
- Xia Bi, Site 01173
- Phone Number: 302-220-7456
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Children's Hospital of Philadelphia-Center for Childhood Cancer Research
-
Contact:
- Stephan Grupp, Site 01061
- Phone Number: 215-590-5476
-
Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- UPMC Cancer Pavillion
-
Contact:
- Alison Sehgal, Site 01210
- Phone Number: 412-648-6579
-
-
South Carolina
-
Greenville, South Carolina, United States, 29615
- Recruiting
- Hematology and Oncology Associates of SC, LLC
-
Contact:
- Saeeda Chowdhury, Site 01034
- Phone Number: 864-241-6252
-
-
South Dakota
-
Sioux Falls, South Dakota, United States, 57105
- Withdrawn
- Local Institution - 01064
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Sarah Cannon Research Inst
-
Contact:
- Jesus Berdeja, Site 01101
- Phone Number: 615-329-0570
-
-
Texas
-
Dallas, Texas, United States, 75246
- Recruiting
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
-
Contact:
- Houston Holmes, Site 01180
- Phone Number: 214-584-3402
-
Dallas, Texas, United States, 75390
- Recruiting
- UT southwestern Medical Center
-
Contact:
- Larry Anderson, Site 01104
- Phone Number: 214-648-5906
-
Dallas, Texas, United States, 75230
- Recruiting
- Texas Oncology
-
Contact:
- Jay Courtright, Site 01044
- Phone Number: 972-566-4291
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas Health Science Center at Houston
-
Contact:
- Maureen Mayes, Site 01215
- Phone Number: 713-500-6905
-
Houston, Texas, United States, 77030
- Recruiting
- University of Texas- MD Anderson
-
Contact:
- Hun Lee, Site 01013
- Phone Number: 713-794-1829
-
San Antonio, Texas, United States, 78229
- Recruiting
- Sam Clinical Research Center
-
Contact:
- Paul Shaughnessy, Site 01211
- Phone Number: 210-670-2313
-
Temple, Texas, United States, 76508
- Withdrawn
- Local Institution - 01033
-
Tyler, Texas, United States, 75702
- Recruiting
- Texas Oncology, P.A. - Tyler
-
Contact:
- Habte Yimer, Site 01054
- Phone Number: 903-579-9800
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- University of Utah - Huntsman Cancer Institute
-
Contact:
- Douglas Sborov, Site 01199
- Phone Number: 801-585-0255
-
Salt Lake City, Utah, United States, 84143
- Recruiting
- Intermountain Healthcare - LDS Hospital
-
Contact:
- Dannish Hoda, Site 01029
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- Recruiting
- University of Virginia Health System
-
Contact:
- Indumathy Varadarajan, Site 01065
- Phone Number: 434-924-9333
-
Norfolk, Virginia, United States, 23502
- Completed
- Local Institution - 01045
-
Richmond, Virginia, United States, 23298
- Withdrawn
- Local Institution - 01023
-
-
Washington
-
Seattle, Washington, United States, 98104
- Recruiting
- Swedish Cancer Institute
-
Contact:
- Daniel Egan, Site 01166
- Phone Number: 617-699-2437
-
Seattle, Washington, United States, 98109
- Recruiting
- Fred Hutchinson Cancer Center
-
Contact:
- Jordan Gauthier, Site 01110
- Phone Number: 206-667-2713
-
Seattle, Washington, United States, 98105
- Withdrawn
- Local Institution - 01060
-
Tacoma, Washington, United States, 98405
- Withdrawn
- Local Institution - 01055
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- Recruiting
- University of Wisconsin
-
Contact:
- Natalie Callander, Site 01036
- Phone Number: 082658690
-
Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Froedtert Hospital BMT Medical College of Wisconsin
-
Contact:
- Othman Akhtar, Site 01178
-
Wauwatosa, Wisconsin, United States, 53226
- Not yet recruiting
- Local Institution - 01069
-
Contact:
- Site 01069
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Participants exposed to Gene-modified (GM) T cell therapy
|
No investigational product will be administered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of delayed Adverse Events (AEs)
Time Frame: Up to 15 years from last gene-modified (GM) T cell infusion
|
Up to 15 years from last gene-modified (GM) T cell infusion
|
|
Analysis of vector integration sites
Time Frame: Up to 15 years from last GM T cell infusion
|
Up to 15 years from last GM T cell infusion
|
|
Incidence of replication-competent lentiviruses
Time Frame: Up to 15 years from last GM T cell infusion
|
Up to 15 years from last GM T cell infusion
|
|
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
|
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)
Time Frame: Up to 15 years from last GM T cells infusion or until Tanner Stage 5
|
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
Time Frame: Up to 15 years from last GM T cells infusion
|
Up to 15 years from last GM T cells infusion
|
|
Overall Survival (participants with original diagnosis of malignancies)
Time Frame: Up to 15 years from last GM T cells infusion
|
Up to 15 years from last GM T cells infusion
|
|
Persistence of GM T cell drug products
Time Frame: Up to 15 years from last GM T cell infusion
|
Up to 15 years from last GM T cell infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lymphocyte count (B-cell)
Time Frame: Up to 15 years
|
If B-cell recovery criteria are not met at Month 60 (Year 5), then annual monitoring will continue up to 15 years, until subject withdrawal of consent, or death, whichever occurs first.
|
Up to 15 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GC-LTFU-001
- U1111-1206-8250 (Registry Identifier: WHO)
- 2023-504201-36 (Other Identifier: EU CTR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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