Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Celgene
Study ID
NCT03435796
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gene-modified (GM) T cell therapy — GENETIC
    No investigational product will be administered

Study Details

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.

Key Dates

Start date
Jul 19, 2018
Status verified
Jun 2026
Primary completion
Nov 30, 2036
Completion
Nov 30, 2036

Study Design

Enrollment
1,541 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Participants exposed to Gene-modified (GM) T cell therapy

Primary Outcome Measure

Incidence of delayed Adverse Events (AEs) [ Time Frame: Up to 15 years from last gene-modified (GM) T cell infusion ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (100)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama10016
Luciano Costa, Site 01171
205-934-9695
Banner MD Anderson Cancer CenterGilbertArizona85234
Rajneesh Nath, Site 01049
480-256-3223
Mayo Clinic PhoenixPhoenixArizona85054
Jeremy Larsen, Site 01200
Local Institution - 01039ScottsdaleArizona85258-
Local Institution - 01021TucsonArizona85724-
City Of HopeDuarteCalifornia91010
Tanya Siddiqi, Site 01011
626-256-4673
University Of California San Diego Moores Cancer CenterLa JollaCalifornia92093
Thomas Kipps, Site 01019
858-822-6135
Local Institution - 01206Los AngelesCalifornia90048-
Local Institution - 01043SacramentoCalifornia95816-
University of California, San Francisco- CaliforniaSan FranciscoCalifornia94143
Charalambos Andreadis, Site 01108
415-238-1909
UCLA Medical Centre-Santa MonicaSanta MonicaCalifornia90095
Sarah Larson, Site 01184
310-829-5471
Stanford Cancer CenterStanfordCalifornia94305
Michaela Liedtke, Site 01119
650-498-6000
University Of Colorado Cancer CenterAuroraColorado80045
Manali Kamdar, Site 01208
720-848-0752
Colorado Blood Cancer InstituteDenverColorado80218
Tara Gregory, Site 01212
720-754-4800
Yale Cancer CenterNew HavenConnecticut06520
Iris Isufi, Site 01059
203-688-4242
Local Institution - 01050Washington D.C.District of Columbia20007-
The Mayo Clinic - Jacksonville, Davis-EJacksonvilleFlorida32224
Sikander Ailawadhi, Site 01201
904-953-0853
Baptist Cancer CenterMiamiFlorida33176
Yuliya Linhares, Site 01047
786-596-2000
Local Institution - 01035OrlandoFlorida32804-
H. Lee Moffitt Cancer Center and Research Institute University of South FloridaTampaFlorida33612
Melissa Alsina, Site 01153
813-745-7202
Northside Hospital, IncAtlantaGeorgia30342
Scott Solomon, Site 01207
404-255-1930
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322
Sagar Lonial, Site 01103
404-778-1900
Northwestern Memorial HospitalChicagoIllinois60611
Reem Karmali, Site 01014
312-695-0990
University Of Chicago Medical CenterChicagoIllinois60637-1447
Peter Riedell, Site 01018
773-702-8412
Local Institution - 01040MaywoodIllinois60153-
Local Institution - 01063NilesIllinois60714-
Franciscan Health IndianapolisIndianapolisIndiana46237
Anand Tandra, Site 01217
317-871-0000
IN Univ Simon Cancer CenterIndianapolisIndiana46202
Rafat Abonour, Site 01161
317-690-1577
Local Institution - 01020IndianapolisIndiana46237-
Kansas University Medical CenterWestwoodKansas66205
Al-Ola Abdallah, Site 01174
918-261-6196
Cancer Center of KansasWichitaKansas67214
Bassam Mattar, Site 01031
316-262-4467
University Of KentuckyLexingtonKentucky40536
Chaitanya Iragavarapu, Site 01046
Norton Cancer Institute Louisville OncologyLouisvilleKentucky40207
Don Stevens, Site 01032
502-899-3366
Local Institution - 01026New OrleansLouisiana70112-
Sidney Kimmel Comp Cancer Center at Johns HopkinsBaltimoreMaryland21231
Syed Abbas Ali, Site 01017
443-287-7104
University of Maryland - Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201
Mehmet Kocoglu, Site 01164
501-526-6990
National Cancer InstituteBethesdaMaryland20892-1203
James Kochenderfer, Site 01114
Local Institution - 01106BostonMassachusetts02115-
Local Institution - 01107BostonMassachusetts02114-
Massachusetts General Hospital / Dana-Farber Cancer InstituteBostonMassachusetts02114
Jeremy Abramson, Site 01012
617-571-3037
University Of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109
Monalisa Ghosh, Site 01024
734-936-4000
Karmanos Cancer Center Wayne State UniversityDetroitMichigan48201
Abhinav Deol, Site 01025
313-576-8093
Providence Cancer InstituteSouthfieldMichigan48075
Leo Reap, Site 01056
M Health Fairview University of Minnesota Medical Center - East BankMinneapolisMinnesota55455
Veronika Bachanova, Site 01112
612-625-5469
Mayo ClinicRochesterMinnesota55905
Yi Lin, Site 01105
Siteman Cancer CenterSt LouisMissouri63110
Ravi Vij, Site 01176
314-409-4144
University Of Nebraska Medical CenterOmahaNebraska68198-6840
Matthew Lunning, Site 01015
402-559-7164
Local Institution - 01030East BrunswickNew Jersey08816-
Hackensack University Medical CenterHackensackNew Jersey07601
David Siegel, Site 01102
201-996-5900
Morristown Memorial HospMorristownNew Jersey07962
Mohamad Cherry, Site 01027
973-971-7906
Local Institution - 01053New BrunswickNew Jersey08903-
New York Oncology Hematology P.C.AlbanyNew York12206
Courtney Bellomo, Site 01041
Roswell Park Cancer InstituteBuffaloNew York14263
Francisco Hernandez-Ilizaliturri, Site 01111
716-845-3099
Columbia University Medical Center/New York-Presbyterian HospitalNew YorkNew York10032
Ran Reshef, Site 01209
212-342-0530
Icahn School Of Medicine At Mount SinaiNew YorkNew York10029
Sundar Jagannath, Site 01109
212-241-7873
Local Institution - 01066New YorkNew York10016-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Maria Palomba, Site 01177
212-639-7186
New York University - Langone Medical Center - The Center for Musculoskeletal CareNew YorkNew York10016
Amit Saxena, Site 01070
646-501-7400
Weill Cornell Medicine / New York Presbyterian HospitalNew YorkNew York10021
Roger Niles Pearse, Site 01198
212-746-2956
Local Institution - 01051RochesterNew York14642-
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Saira Sheikh, Site 01071
919-966-0545
Levine Cancer InstituteCharlotteNorth Carolina28204
Bei Hu, Site 01204
980-442-5231
Duke University Medical CenterDurhamNorth Carolina27705
Taewoong Choi, Site 01175
Novant HealthSalisburyNorth Carolina28147
Alan Skarbnik, Site 01058
347-266-6406
Oncology Hematology Care, Inc.CincinnatiOhio45242
James Essell, Site 01037
513-686-5482
Cleveland Clinic FoundationClevelandOhio44195
Brian Hill, Site 01062
216-445-9451
University Hospitals of ClevelandClevelandOhio44106-5000
Leland Metheny, Site 01042
216-844-0139
Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research InstituteColumbusOhio43210
Srinivas Devarakonda, Site 01074
570-423-0522
University of Oklahoma Peggy and Charles Stephenson Cancer CenterOklahoma CityOklahoma73104
Adam Asch, Site 01038
405-271-4022
Willamette Valley Cancer InstituteEugeneOregon97401
Jeff Sharman, Site 01052
541-683-5001
Oregon Health and Science University OHSUPortlandOregon97239
Richard Maziarz, Site 01022
503-231-2498
Providence Portland Medical CenterPortlandOregon97213
Stacy Lewis, Site 01028
503-215-5696
Children's Hospital of Philadelphia-Center for Childhood Cancer ResearchPhiladelphiaPennsylvania19104
Stephan Grupp, Site 01061
215-590-5476
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Asya Varshavsky-Yanovsky, Site 01172
Thomas Jefferson University - Clinical Research InstitutePhiladelphiaPennsylvania19107
Xia Bi, Site 01173
302-220-7456
University of Pennsylvania Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104
Stephen Schuster, Site 01016
215-614-1846
UPMC Cancer PavillionPittsburghPennsylvania15232
Alison Sehgal, Site 01210
412-648-6579
Hematology and Oncology Associates of SC, LLCGreenvilleSouth Carolina29615
Saeeda Chowdhury, Site 01034
864-241-6252
Local Institution - 01064Sioux FallsSouth Dakota57105-
Sarah Cannon Research InstNashvilleTennessee37203
Jesus Berdeja, Site 01101
615-329-0570
Texas OncologyDallasTexas75230
Jay Courtright, Site 01044
972-566-4291
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallasTexas75246
Houston Holmes, Site 01180
214-584-3402
UT Southwestern Medical CenterDallasTexas75390
Larry Anderson, Site 01104
214-648-5906
The University of Texas Health Science Center at HoustonHoustonTexas77030
Maureen Mayes, Site 01215
713-500-6905
University of Texas- MD AndersonHoustonTexas77030
Hun Lee, Site 01013
713-794-1829
Sam Clinical Research CenterSan AntonioTexas78229
Paul Shaughnessy, Site 01211
210-670-2313
Local Institution - 01033TempleTexas76508-
Local Institution - 01054TylerTexas75702-
Intermountain Healthcare - LDS HospitalSalt Lake CityUtah84143
Dannish Hoda, Site 01029
University of Utah - Huntsman Cancer InstituteSalt Lake CityUtah84112
Douglas Sborov, Site 01199
801-585-0255
University Of Virginia Health SystemCharlottesvilleVirginia22903
Indumathy Varadarajan, Site 01065
434-924-9333
Local Institution - 01045NorfolkVirginia23502-
Local Institution - 01023RichmondVirginia23298-
Fred Hutchinson Cancer CenterSeattleWashington98109
Jordan Gauthier, Site 01110
206-667-2713
Local Institution - 01060SeattleWashington98105-
Swedish Cancer InstituteSeattleWashington98104
Daniel Egan, Site 01166
617-699-2437
Local Institution - 01055TacomaWashington98405-
University Of WisconsinMadisonWisconsin53705
Natalie Callander, Site 01036
082658690
Froedtert Hospital BMT Medical College of WisconsinMilwaukeeWisconsin53226
Othman Akhtar, Site 01178
Local Institution - 01069WauwatosaWisconsin53226
Site 01069

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