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

StatusRecruiting
PhasePhase 2/3
SponsorCelgene
Started2018-07-19
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 77 months later Nov 30, 2036 → May 29, 2043
See other at-risk trials from Bristol-Myers Squibb

Amendment history

The 50 most recent of 81 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-03
Study Status, Contacts/Locations v80
Trial sites expanded: 213 → 222 locations
Primary completion pushed: 2036-11-30 → 2043-05-29
Completion pushed: 2036-11-30 → 2043-05-29
Trial sites expanded: 209 → 213 locations
2026-07-29
Study Status, Contacts/Locations v79
Trial sites expanded: 206 → 209 locations
2026-07-09
Study Status, Contacts/Locations v78
Study sites205→206
2026-06-01
Study Status, Contacts/Locations v77
Trial sites expanded: 200 → 205 locations
2026-03-03
Study Status, Contacts/Locations v76
Study sites191→200
Show 45 earlier versions
2026-02-09
Study Status, Contacts/Locations, IPDSharing v75
Study sites186→191
2026-01-23
Study Status, Contacts/Locations v74
Study sites185→186
2026-01-15
Study Status, Outcome Measures, Eligibility, Contacts/Locations v73
Study sites182→185
Eligibility criteria+45 characters
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 disco [...]
Secondary endpointsdetails revised at 1 of 1 entry
Primary endpoints9 to 8 entries
Number of participants with reintroduction of standard treatments for the control of autoimmune disease activity as a surrogate for disease relapse Persistence of GM T cellscell drug products
2025-06-24
Study Status, Contacts/Locations v72
Study sites182 entries, revised
LocalJules InstitutionBordet Institut Centre Hospitalier Universitaire (CHU) de Bordeaux - 05202 LocalHopital Institution Haut- 09210Leveque
2025-06-09
Study Status, Contacts/Locations v71
Study sites179→182
2025-05-22
Study Status, Contacts/Locations v70
Study sites178→179
2025-04-11
Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v69
Enrollment target317→1541
Eligibility criteriarevised
[...] ous Celgene sponsored or Celgene alliance partner-sponsored studytrial, and have discontinued, or completed the post-treatment fol [...]
Primary endpoints10 to 9 entries
DiseaseNumber Progression:of Numberparticipants with reintroduction of standard treatments for the control of autoimmune disease activity as a surrogate for disease relapse Overall Survival (participants with original diagnosis of malignancies) Proportion of participants who continueprogressed toon bethe responders, who have progressed, and who have relapsed will be reported. Disease Relapsestudy: Numberparticipants with original diagnosis of participants who continue to be responders, who have progressed, and who have relapsed will be reported. Disease status of the primary malignancy Overall [...] [...]
Study sitescontacts updated at 2 of 178 sites
2025-03-21
Study Status, Contacts/Locations v68
Study sites178 entries, revised
The Children'Ss Hospital Ofof Philadelphia-Center for Childhood Cancer Research LocalHopital InstitutionHenri - 09211Mondor
2025-02-25
Study Status, Contacts/Locations v67
Study sites173→178
2025-01-23
Study Status, Contacts/Locations v66
Start date2018-06-19→2018-07-19
Study sites173 entries, revised
LocalCIUSSS Institutionde l'Est- 02800de-l'Ile-de-Montreal
2024-08-05
Study Status, Contacts/Locations v65
Study sites173 entries, revised
UniversitaetsklinikumLocal TuebingenInstitution - 03503
2024-05-20
Study Status, Contacts/Locations v64
Study sitesdetails revised at 3 of 173 sites
2024-04-26
Study Status, Contacts/Locations, References v63
Study sites106→173
2024-03-11
Study Status, Contacts/Locations v62
Study sites105→106
2023-12-22
Study Status, Contacts/Locations v61
Study sites104→105
2023-11-29
Study Status, Contacts/Locations v60
Study sites101→104
2023-10-31
Study Status, Contacts/Locations v59
Study sites76→101
2023-09-27
Study Status, Contacts/Locations, References v58
Study sites67→76
2023-08-30
Study Status, Contacts/Locations v57
Study sites66→67
2023-07-25
Study Status, Contacts/Locations v56
Study sites64→66
2023-06-13
Study Status, Contacts/Locations v55
Study sites61→64
2023-04-19
Study Status, Contacts/Locations v54
Study sites60→61
2023-03-13
Study Status, Contacts/Locations v53
Study sites59→60
2023-03-03
Study Status, Contacts/Locations v52
Study sites57→59
2023-02-21
Study Status, Contacts/Locations v51
Study sites56→57
2023-02-17
Study Status, Contacts/Locations v50
Study sites54→56
2023-02-13
Study Status, Contacts/Locations v49
Study sites217→54
2022-12-22
Study Status, Contacts/Locations v48
Study sites205→217
2022-12-05
Study Status, Contacts/Locations v47
Study sites204→205
2022-11-23
Study Status, Contacts/Locations v46
Study sites203→204
2022-11-04
Study Status, Contacts/Locations v45
Study sites202→203
2022-10-28
Study Status, Contacts/Locations v44
Study sites201→202
2022-10-24
Study Status, Study Design, Outcome Measures, Contacts/Locations v43
Enrollment target191→317
Study sites199→201
Secondary endpoints1 entry, revised
Health-relatedLymphocyte quality of lifecount (HRQoLB-cell): Measurement of HRQoL changes as assessed using instruments administered in the parent treatment protocol
2022-09-22
Study Status, Contacts/Locations v42
Study sites198→199
2022-09-06
Study Status, Contacts/Locations v41
Study sites175→198
2022-08-19
Study Status, Contacts/Locations v40
Study sites174→175
2022-08-01
Study Status, Contacts/Locations v39
Study sites173→174
2022-07-28
Study Status, Contacts/Locations v38
Study sites172→173
2022-07-18
Study Status, Contacts/Locations v37
Study sites171→172
2022-06-28
Study Status, Contacts/Locations v36
Study sites169→171
2022-05-19
Study Status, Contacts/Locations v35
Study sites167→169
2022-04-26
Study Status, Contacts/Locations v34
Study sites165→167
2022-02-23
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v33
Primary completion date2032-11-30→2036-11-30
Completion date2032-11-30→2036-11-30
Study sites163→165
Eligibility criteria-232 characters
Inclusion Criteria: Subjects who meet the following criteria will be eligible to participate in the Long-Term Follow-Up study: All adult and pediatric subjects who receivedReceived at least one gene-modified (GM) T cells-cell infusion in a previous Celgene sponsored or Celgene alliance partner-sponsored study, and have discontinued, or completed the pos [...] -up period in the parent treatment protocol, as applicable. Subject (and, parental/legal representative, when applicable) mustMust understand and voluntarily sign an Informed Consent Form/In [...] o any study-related assessments/procedures being conduc [...]
Secondary endpoints+144 characters
Health-related quality of life (HRQoL): Measurement of HRQoL changes as assessed using instruments administered in the parent treatment protocol
Primary endpoints9 to 10 entries
Analysis of vector integration sites Disease Progression: Number of participants who continue to be responders, who have progressed, and who have relapsed will be reported. Disease Relapse: Number of participants who continue to be responders, who have progressed, and who have relapsed will be repor [...] Adverse Events (AEs) Disease Progression Disease Relapse Health-related qualityIncidence of lifereplication-competent (HRQoL)lentiviruses HeightIncidence of sexual maturation as assessed by the Tanner staging system (pediatric subjectsparticipants treatedonly) Overall withSurvival defined as the tim [...] [...]
Study description-511 characters
Subjects participating in this study will be followed from time of roll-over from the parent GM T protocol until 15 years after the last GMT infusion, withdrawal of consent, lost to follow-up, or death, whichever occurs first. Both local and central laboratory evaluations and safety assessments will [...]
Study title+4 characters
Long-Term Follow-up Protocol for SubjectsParticipants Treated With Gene-Modified T Cells
2021-07-11
Study Status v32
Re-verified, no change to tracked fields
2021-02-12
Study Status, Contacts/Locations v31
Study sites148→163
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.
Trial Details
NCT Number NCT03435796
Lead Sponsor Celgene
Conditions Neoplasms
Enrollment 1,541 participants
Start Date 2018-07-19
Primary Completion 2043-05-29 (estimated)
Study Completion 2043-05-29 (estimated)
Updated on ClinicalTrials.gov 2026-09-18