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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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…

Fase 2 / Fase 31541 partecipanti ricercati222 centri22 paesi

Categorie

Oncologia100%

Registrato in 1 registro

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

  • Neoplasms

Idoneità

SessoTutti
EtàNon indicato nella scheda del registro
Volontari saniNo

Idoneità come riportata nel registro

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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 2 / Fase 3
AssegnazioneNon applicabile
Modello di interventoSINGLE_GROUP
Finalità principaleOTHER
MascheramentoNONE (0)
Arruolamento1541 partecipanti ricercati

Sponsor e collaboratori

  • Celgene Sponsor

Bracci e interventi

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

Interventi

  • Genetico Gene-modified (GM) T cell therapy

    No investigational product will be administered

Esiti misurati

  1. Esito primario

    Incidence of delayed Adverse Events (AEs)

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

  2. Esito primario

    Persistence of GM T cell drug products

    Orizzonte temporale Up to 15 years from last GM T cell infusion

  3. Esito primario

    Analysis of vector integration sites

    Orizzonte temporale Up to 15 years from last GM T cell infusion

  4. Esito primario

    Incidence of replication-competent lentiviruses

    Orizzonte temporale Up to 15 years from last GM T cell infusion

  5. Esito primario

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

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

  6. Esito primario

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

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

  7. Esito primario

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

    Orizzonte temporale Up to 15 years from last GM T cells infusion

  8. Esito primario

    Overall Survival (participants with original diagnosis of malignancies)

    Orizzonte temporale Up to 15 years from last GM T cells infusion

  9. Esito secondario

    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.

    Orizzonte temporale Up to 15 years

Date

Data di inizio19 luglio 2018 (effettiva)
Conclusione primaria29 maggio 2043 (stimata)
Conclusione29 maggio 2043 (stimata)
Prima pubblicazione19 febbraio 2018 (effettiva)
Ultimo aggiornamento18 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

173 centri stanno reclutando

Australia

StrutturaCittàStato o regioneStato
Royal Prince Alfred HospitalCamperdownNew South WalesIn reclutamento
Peter MacCallum Cancer CentreMelbourneVictoriaIn reclutamento
The Alfred HospitalMelbourneVictoriaIn reclutamento
Fiona Stanley HospitalMurdochWestern AustraliaIn reclutamento

Austria

StrutturaCittàStato o regioneStato
Ordensklinikum Linz GmbH ElisabethinenLinzIn reclutamento
Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet WienViennaIn reclutamento

Belgium

StrutturaCittàStato o regioneStato
Jules Bordet InstitutAnderlechtIn reclutamento
Universitair Ziekenhuis BrusselBrusselsIn reclutamento
Local Institution - 05200GhentRitirato
Uz GentGhentIn reclutamento
University Hospital LeuvenLeuvenIn reclutamento
Local Institution - UNK 2LeuvenRitirato

Canada

StrutturaCittàStato o regioneStato
University Of CalgaryCalgaryAlbertaIn reclutamento
Local Institution - 02801HamiltonOntarioRitirato
CIUSSS de l'Est-de-l'Ile-de-MontrealMontrealQuebecIn reclutamento
Princess Margaret Cancer CentreTorontoOntarioIn reclutamento
Local Institution - 02802VancouverBritish ColumbiaRitirato

Denmark

StrutturaCittàStato o regioneStato
Local Institution - 20003AarhusNon ancora in reclutamento
Odense University HospitalOdenseIn reclutamento
Roskilde SygehusRoskildeRegion SjællandIn reclutamento

Finland

StrutturaCittàStato o regioneStato
Helsinki University Central Hospital (HUCH)HelsinkiIn reclutamento
Turku University HospitalTurkuIn reclutamento

France

StrutturaCittàStato o regioneStato
Hopital Henri MondorCreteil-ParisIn reclutamento
CHRU de Lille FranceLilleIn reclutamento
Local Institution - 09601LyonRitirato
Local Institution - 09400MarseilleCompletato
Local Institution - 09602MarseilleRitirato
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de VilleneuveMontpellierIn reclutamento
CHU Montpellier - Hôpital Saint EloiMontpellierIn reclutamento
Chu Hotel DieuNantesIn reclutamento
Hopital Saint LouisParisIn reclutamento
Hôpitaux Universitaires Pitie Salpêtrière Charles FoixParisIn reclutamento
Hospital Saint LouisParisIn reclutamento
Local Institution - 09600ParisRitirato
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Haut-LevequePessacIn reclutamento
Centre Hospitalier Lyon-SudPierre-BéniteIn reclutamento
CHU La MiletriePoitiersIn reclutamento
Hopital SudRennesIn reclutamento
Institut Universitaire du Cancer de Toulouse - OncopoleToulouseIn reclutamento
Gustave RoussyVillejuifIn reclutamento

Germany

StrutturaCittàStato o regioneStato
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)BerlinIn reclutamento
Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. TumorimmunoBerlinIn reclutamento
Local Institution - 03155BerlinNon ancora in reclutamento
Kinikum der Universitaeat zu KoelnCologneIn reclutamento
Universitatsklinikum Carl Gustav Carus an der TU DresdenDresdenIn reclutamento
Local Institution - 03513DüsseldorfRitirato
Universitaetsklinikum DuesseldorfDüsseldorfIn reclutamento
Universitaetsklinikum EssenEssenIn reclutamento
Local Institution - 03500FrankfurtRitirato
Universitaetsklinikum Hamburg-EppendorfHamburgIn reclutamento

Nella scheda del registro sono indicati altri 172 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 18 settembre 2026

    Data di conclusione posticipata

    Primary completion delayed 2371 days

    2036-11-302043-05-29

  2. 18 settembre 2026

    Centro aggiunto

    9 sites added (222 total)

    213222

  3. 4 settembre 2026

    Centro aggiunto

    4 sites added (213 total)

    209213

  4. 30 luglio 2026

    Centro aggiunto

    3 sites added (209 total)

    206209

Registro: ClinicalTrials.gov · NCT########

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