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NCT03435796ClinicalTrials.gov

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

RecruitingTaking participants now, according to the registry record.
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In brief

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…

Phase 2 / Phase 31,541 participants sought222 sites22 countries

Categories

Oncology100%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2018-02-19; recorded start 2018-07-19
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are not randomly assignedAllocation is recorded as non-randomised
  • A comparison group is not stated in the registry recordThe record describes a single study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 107 other studies in this databaseCounted from the lead sponsor named in the record (Celgene)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Allocation not stated in the record

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 206 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,541 participants (target), run at 222 sites, across 22 countries.

How this score is built
  • Enrolment32/40

    1,541 participants (target)

  • Site count25/25

    206 sites

  • Country count15/15

    20 countries

  • Planned duration10/10

    Planned over about 224 months

  • Sponsor scale8/10

    Celgene has led 111 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

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 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.

Conditions

  • Neoplasms

Eligibility

SexAll
AgesNot stated in the registry record
Healthy volunteersNo

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhasePhase 2 / Phase 3
AllocationNot applicable
Intervention modelSINGLE_GROUP
Primary purposeOTHER
MaskingNONE (0)
Enrolment1,541 participants sought

Sponsor and collaborators

  • Celgene Sponsor

Arms and interventions

  • Participants exposed to Gene-modified (GM) T cell therapyOTHER

Interventions

  • Genetic Gene-modified (GM) T cell therapy

    No investigational product will be administered

Outcome measures

  1. Primary outcome

    Incidence of delayed Adverse Events (AEs)

    Time frame Up to 15 years from last gene-modified (GM) T cell infusion

  2. Primary outcome

    Persistence of GM T cell drug products

    Time frame Up to 15 years from last GM T cell infusion

  3. Primary outcome

    Analysis of vector integration sites

    Time frame Up to 15 years from last GM T cell infusion

  4. Primary outcome

    Incidence of replication-competent lentiviruses

    Time frame Up to 15 years from last GM T cell infusion

  5. Primary outcome

    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

  6. Primary outcome

    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

  7. Primary outcome

    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

  8. Primary outcome

    Overall Survival (participants with original diagnosis of malignancies)

    Time frame Up to 15 years from last GM T cells infusion

  9. Secondary outcome

    Lymphocyte count (B-cell)

    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.

    Time frame Up to 15 years

Dates

Start dateJuly 19, 2018 (actual)
Primary completionMay 29, 2043 (estimated)
CompletionMay 29, 2043 (estimated)
First postedFebruary 19, 2018 (actual)
Last updatedSeptember 18, 2026
Results postedNot stated in the registry record
Status last verifiedSeptember 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

173 sites are recruiting

Australia

FacilityCityState or regionStatus
Royal Prince Alfred HospitalCamperdownNew South WalesRecruiting
Peter MacCallum Cancer CentreMelbourneVictoriaRecruiting
The Alfred HospitalMelbourneVictoriaRecruiting
Fiona Stanley HospitalMurdochWestern AustraliaRecruiting

Austria

FacilityCityState or regionStatus
Ordensklinikum Linz GmbH ElisabethinenLinzRecruiting
Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet WienViennaRecruiting

Belgium

FacilityCityState or regionStatus
Jules Bordet InstitutAnderlechtRecruiting
Universitair Ziekenhuis BrusselBrusselsRecruiting
Local Institution - 05200GhentWithdrawn
Uz GentGhentRecruiting
University Hospital LeuvenLeuvenRecruiting
Local Institution - UNK 2LeuvenWithdrawn

Canada

FacilityCityState or regionStatus
University Of CalgaryCalgaryAlbertaRecruiting
Local Institution - 02801HamiltonOntarioWithdrawn
CIUSSS de l'Est-de-l'Ile-de-MontrealMontrealQuebecRecruiting
Princess Margaret Cancer CentreTorontoOntarioRecruiting
Local Institution - 02802VancouverBritish ColumbiaWithdrawn

Denmark

FacilityCityState or regionStatus
Local Institution - 20003AarhusNot yet recruiting
Odense University HospitalOdenseRecruiting
Roskilde SygehusRoskildeRegion SjællandRecruiting

Finland

FacilityCityState or regionStatus
Helsinki University Central Hospital (HUCH)HelsinkiRecruiting
Turku University HospitalTurkuRecruiting

France

FacilityCityState or regionStatus
Hopital Henri MondorCreteil-ParisRecruiting
CHRU de Lille FranceLilleRecruiting
Local Institution - 09601LyonWithdrawn
Local Institution - 09400MarseilleCompleted
Local Institution - 09602MarseilleWithdrawn
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de VilleneuveMontpellierRecruiting
CHU Montpellier - Hôpital Saint EloiMontpellierRecruiting
Chu Hotel DieuNantesRecruiting
Hopital Saint LouisParisRecruiting
Hôpitaux Universitaires Pitie Salpêtrière Charles FoixParisRecruiting
Hospital Saint LouisParisRecruiting
Local Institution - 09600ParisWithdrawn
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Haut-LevequePessacRecruiting
Centre Hospitalier Lyon-SudPierre-BéniteRecruiting
CHU La MiletriePoitiersRecruiting
Hopital SudRennesRecruiting
Institut Universitaire du Cancer de Toulouse - OncopoleToulouseRecruiting
Gustave RoussyVillejuifRecruiting

Germany

FacilityCityState or regionStatus
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)BerlinRecruiting
Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. TumorimmunoBerlinRecruiting
Local Institution - 03155BerlinNot yet recruiting
Kinikum der Universitaeat zu KoelnCologneRecruiting
Universitatsklinikum Carl Gustav Carus an der TU DresdenDresdenRecruiting
Local Institution - 03513DüsseldorfWithdrawn
Universitaetsklinikum DuesseldorfDüsseldorfRecruiting
Universitaetsklinikum EssenEssenRecruiting
Local Institution - 03500FrankfurtWithdrawn
Universitaetsklinikum Hamburg-EppendorfHamburgRecruiting

172 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

  1. September 18, 2026

    Completion date moved later

    Primary completion delayed 2371 days

    2036-11-302043-05-29

  2. September 18, 2026

    Site added

    9 sites added (222 total)

    213222

  3. September 4, 2026

    Site added

    4 sites added (213 total)

    209213

  4. July 30, 2026

    Site added

    3 sites added (209 total)

    206209

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT03435796