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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

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En resumen

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 participantes buscados222 centros22 países

Categorías

Oncología100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

Resumen

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.

Afecciones

  • Neoplasms

Elegibilidad

SexoTodos
EdadesNo indicado en el registro
Voluntarios sanosNo

Elegibilidad tal como figura en el 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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 2 / Fase 3
AsignaciónNo aplicable
Modelo de intervenciónSINGLE_GROUP
Propósito principalOTHER
EnmascaramientoNONE (0)
Inscripción1541 participantes buscados

Patrocinador y colaboradores

  • Celgene Patrocinador

Grupos e intervenciones

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

Intervenciones

  • Genético Gene-modified (GM) T cell therapy

    No investigational product will be administered

Variables de resultado

  1. Variable de resultado principal

    Incidence of delayed Adverse Events (AEs)

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

  2. Variable de resultado principal

    Persistence of GM T cell drug products

    Plazo Up to 15 years from last GM T cell infusion

  3. Variable de resultado principal

    Analysis of vector integration sites

    Plazo Up to 15 years from last GM T cell infusion

  4. Variable de resultado principal

    Incidence of replication-competent lentiviruses

    Plazo Up to 15 years from last GM T cell infusion

  5. Variable de resultado principal

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

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

  6. Variable de resultado principal

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

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

  7. Variable de resultado principal

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

    Plazo Up to 15 years from last GM T cells infusion

  8. Variable de resultado principal

    Overall Survival (participants with original diagnosis of malignancies)

    Plazo Up to 15 years from last GM T cells infusion

  9. Variable de resultado secundaria

    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.

    Plazo Up to 15 years

Fechas

Fecha de inicio19 de julio de 2018 (real)
Finalización principal29 de mayo de 2043 (estimada)
Finalización29 de mayo de 2043 (estimada)
Primera publicación19 de febrero de 2018 (real)
Última actualización18 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

173 centros están en reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Royal Prince Alfred HospitalCamperdownNew South WalesEn reclutamiento
Peter MacCallum Cancer CentreMelbourneVictoriaEn reclutamiento
The Alfred HospitalMelbourneVictoriaEn reclutamiento
Fiona Stanley HospitalMurdochWestern AustraliaEn reclutamiento

Austria

CentroCiudadEstado o regiónEstado
Ordensklinikum Linz GmbH ElisabethinenLinzEn reclutamiento
Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet WienViennaEn reclutamiento

Belgium

CentroCiudadEstado o regiónEstado
Jules Bordet InstitutAnderlechtEn reclutamiento
Universitair Ziekenhuis BrusselBrusselsEn reclutamiento
Local Institution - 05200GhentRetirado
Uz GentGhentEn reclutamiento
University Hospital LeuvenLeuvenEn reclutamiento
Local Institution - UNK 2LeuvenRetirado

Canada

CentroCiudadEstado o regiónEstado
University Of CalgaryCalgaryAlbertaEn reclutamiento
Local Institution - 02801HamiltonOntarioRetirado
CIUSSS de l'Est-de-l'Ile-de-MontrealMontrealQuebecEn reclutamiento
Princess Margaret Cancer CentreTorontoOntarioEn reclutamiento
Local Institution - 02802VancouverBritish ColumbiaRetirado

Denmark

CentroCiudadEstado o regiónEstado
Local Institution - 20003AarhusAún no recluta
Odense University HospitalOdenseEn reclutamiento
Roskilde SygehusRoskildeRegion SjællandEn reclutamiento

Finland

CentroCiudadEstado o regiónEstado
Helsinki University Central Hospital (HUCH)HelsinkiEn reclutamiento
Turku University HospitalTurkuEn reclutamiento

France

CentroCiudadEstado o regiónEstado
Hopital Henri MondorCreteil-ParisEn reclutamiento
CHRU de Lille FranceLilleEn reclutamiento
Local Institution - 09601LyonRetirado
Local Institution - 09400MarseilleCompletado
Local Institution - 09602MarseilleRetirado
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de VilleneuveMontpellierEn reclutamiento
CHU Montpellier - Hôpital Saint EloiMontpellierEn reclutamiento
Chu Hotel DieuNantesEn reclutamiento
Hopital Saint LouisParisEn reclutamiento
Hôpitaux Universitaires Pitie Salpêtrière Charles FoixParisEn reclutamiento
Hospital Saint LouisParisEn reclutamiento
Local Institution - 09600ParisRetirado
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Haut-LevequePessacEn reclutamiento
Centre Hospitalier Lyon-SudPierre-BéniteEn reclutamiento
CHU La MiletriePoitiersEn reclutamiento
Hopital SudRennesEn reclutamiento
Institut Universitaire du Cancer de Toulouse - OncopoleToulouseEn reclutamiento
Gustave RoussyVillejuifEn reclutamiento

Germany

CentroCiudadEstado o regiónEstado
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)BerlinEn reclutamiento
Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. TumorimmunoBerlinEn reclutamiento
Local Institution - 03155BerlinAún no recluta
Kinikum der Universitaeat zu KoelnCologneEn reclutamiento
Universitatsklinikum Carl Gustav Carus an der TU DresdenDresdenEn reclutamiento
Local Institution - 03513DüsseldorfRetirado
Universitaetsklinikum DuesseldorfDüsseldorfEn reclutamiento
Universitaetsklinikum EssenEssenEn reclutamiento
Local Institution - 03500FrankfurtRetirado
Universitaetsklinikum Hamburg-EppendorfHamburgEn reclutamiento

En el registro figuran 172 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 18 de septiembre de 2026

    Fecha de finalización aplazada

    Primary completion delayed 2371 days

    2036-11-302043-05-29

  2. 18 de septiembre de 2026

    Centro añadido

    9 sites added (222 total)

    213222

  3. 4 de septiembre de 2026

    Centro añadido

    4 sites added (213 total)

    209213

  4. 30 de julio de 2026

    Centro añadido

    3 sites added (209 total)

    206209

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

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