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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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 recherchés222 sites22 pays

Catégories

Oncologie100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Neoplasms

Éligibilité

SexeTous
ÂgesNon précisé dans la fiche du registre
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 2 / Phase 3
RépartitionSans objet
Modèle d'interventionSINGLE_GROUP
Objectif principalOTHER
InsuNONE (0)
Recrutement1 541 participants recherchés

Promoteur et collaborateurs

  • Celgene Promoteur

Groupes et interventions

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

Interventions

  • Génétique Gene-modified (GM) T cell therapy

    No investigational product will be administered

Critères de jugement

  1. Critère de jugement principal

    Incidence of delayed Adverse Events (AEs)

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

  2. Critère de jugement principal

    Persistence of GM T cell drug products

    Délai Up to 15 years from last GM T cell infusion

  3. Critère de jugement principal

    Analysis of vector integration sites

    Délai Up to 15 years from last GM T cell infusion

  4. Critère de jugement principal

    Incidence of replication-competent lentiviruses

    Délai Up to 15 years from last GM T cell infusion

  5. Critère de jugement principal

    Physical growth as assessed by physical examination (pediatric participants only)

    Délai Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached

  6. Critère de jugement principal

    Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only)

    Délai Up to 15 years from last GM T cells infusion or until Tanner Stage 5

  7. Critère de jugement principal

    Proportion of participants who progressed on the study: participants with original diagnosis of malignancies

    Délai Up to 15 years from last GM T cells infusion

  8. Critère de jugement principal

    Overall Survival (participants with original diagnosis of malignancies)

    Délai Up to 15 years from last GM T cells infusion

  9. Critère de jugement secondaire

    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.

    Délai Up to 15 years

Dates

Date de début19 juillet 2018 (réelle)
Achèvement principal29 mai 2043 (estimée)
Achèvement29 mai 2043 (estimée)
Première publication19 février 2018 (réelle)
Dernière mise à jour18 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisseptembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

173 sites sont en recrutement

Australia

ÉtablissementVilleÉtat ou régionStatut
Royal Prince Alfred HospitalCamperdownNew South WalesEn recrutement
Peter MacCallum Cancer CentreMelbourneVictoriaEn recrutement
The Alfred HospitalMelbourneVictoriaEn recrutement
Fiona Stanley HospitalMurdochWestern AustraliaEn recrutement

Austria

ÉtablissementVilleÉtat ou régionStatut
Ordensklinikum Linz GmbH ElisabethinenLinzEn recrutement
Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet WienViennaEn recrutement

Belgium

ÉtablissementVilleÉtat ou régionStatut
Jules Bordet InstitutAnderlechtEn recrutement
Universitair Ziekenhuis BrusselBrusselsEn recrutement
Local Institution - 05200GhentRetiré
Uz GentGhentEn recrutement
University Hospital LeuvenLeuvenEn recrutement
Local Institution - UNK 2LeuvenRetiré

Canada

ÉtablissementVilleÉtat ou régionStatut
University Of CalgaryCalgaryAlbertaEn recrutement
Local Institution - 02801HamiltonOntarioRetiré
CIUSSS de l'Est-de-l'Ile-de-MontrealMontrealQuebecEn recrutement
Princess Margaret Cancer CentreTorontoOntarioEn recrutement
Local Institution - 02802VancouverBritish ColumbiaRetiré

Denmark

ÉtablissementVilleÉtat ou régionStatut
Local Institution - 20003AarhusPas encore en recrutement
Odense University HospitalOdenseEn recrutement
Roskilde SygehusRoskildeRegion SjællandEn recrutement

Finland

ÉtablissementVilleÉtat ou régionStatut
Helsinki University Central Hospital (HUCH)HelsinkiEn recrutement
Turku University HospitalTurkuEn recrutement

France

ÉtablissementVilleÉtat ou régionStatut
Hopital Henri MondorCreteil-ParisEn recrutement
CHRU de Lille FranceLilleEn recrutement
Local Institution - 09601LyonRetiré
Local Institution - 09400MarseilleTerminé
Local Institution - 09602MarseilleRetiré
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de VilleneuveMontpellierEn recrutement
CHU Montpellier - Hôpital Saint EloiMontpellierEn recrutement
Chu Hotel DieuNantesEn recrutement
Hopital Saint LouisParisEn recrutement
Hôpitaux Universitaires Pitie Salpêtrière Charles FoixParisEn recrutement
Hospital Saint LouisParisEn recrutement
Local Institution - 09600ParisRetiré
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Haut-LevequePessacEn recrutement
Centre Hospitalier Lyon-SudPierre-BéniteEn recrutement
CHU La MiletriePoitiersEn recrutement
Hopital SudRennesEn recrutement
Institut Universitaire du Cancer de Toulouse - OncopoleToulouseEn recrutement
Gustave RoussyVillejuifEn recrutement

Germany

ÉtablissementVilleÉtat ou régionStatut
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)BerlinEn recrutement
Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. TumorimmunoBerlinEn recrutement
Local Institution - 03155BerlinPas encore en recrutement
Kinikum der Universitaeat zu KoelnCologneEn recrutement
Universitatsklinikum Carl Gustav Carus an der TU DresdenDresdenEn recrutement
Local Institution - 03513DüsseldorfRetiré
Universitaetsklinikum DuesseldorfDüsseldorfEn recrutement
Universitaetsklinikum EssenEssenEn recrutement
Local Institution - 03500FrankfurtRetiré
Universitaetsklinikum Hamburg-EppendorfHamburgEn recrutement

172 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 18 septembre 2026

    Date d'achèvement reportée

    Primary completion delayed 2371 days

    2036-11-302043-05-29

  2. 18 septembre 2026

    Site ajouté

    9 sites added (222 total)

    213222

  3. 4 septembre 2026

    Site ajouté

    4 sites added (213 total)

    209213

  4. 30 juillet 2026

    Site ajouté

    3 sites added (209 total)

    206209

Registre: ClinicalTrials.gov · NCT########

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