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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

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.
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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 Teilnehmende gesucht222 Studienzentren22 Länder

Kategorien

Onkologie100%

In 1 Register registriert

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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.

Zusammenfassung

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.

Erkrankungen

  • Neoplasms

Eignung

GeschlechtAlle
AlterIm Registereintrag nicht angegeben
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 2 / Phase 3
ZuteilungNicht zutreffend
InterventionsmodellSINGLE_GROUP
Primäres ZielOTHER
VerblindungNONE (0)
Teilnahme1.541 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Celgene Sponsor

Studienarme und Interventionen

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

Interventionen

  • Genetisch Gene-modified (GM) T cell therapy

    No investigational product will be administered

Endpunkte

  1. Primärer Endpunkt

    Incidence of delayed Adverse Events (AEs)

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

  2. Primärer Endpunkt

    Persistence of GM T cell drug products

    Zeitrahmen Up to 15 years from last GM T cell infusion

  3. Primärer Endpunkt

    Analysis of vector integration sites

    Zeitrahmen Up to 15 years from last GM T cell infusion

  4. Primärer Endpunkt

    Incidence of replication-competent lentiviruses

    Zeitrahmen Up to 15 years from last GM T cell infusion

  5. Primärer Endpunkt

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

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

  6. Primärer Endpunkt

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

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

  7. Primärer Endpunkt

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

    Zeitrahmen Up to 15 years from last GM T cells infusion

  8. Primärer Endpunkt

    Overall Survival (participants with original diagnosis of malignancies)

    Zeitrahmen Up to 15 years from last GM T cells infusion

  9. Sekundärer Endpunkt

    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.

    Zeitrahmen Up to 15 years

Daten

Startdatum19. Juli 2018 (tatsächlich)
Primärer Abschluss29. Mai 2043 (geschätzt)
Abschluss29. Mai 2043 (geschätzt)
Erstveröffentlichung19. Februar 2018 (tatsächlich)
Zuletzt aktualisiert18. September 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtSeptember 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

173 Studienzentren rekrutieren

Australia

EinrichtungStadtBundesland oder RegionStatus
Royal Prince Alfred HospitalCamperdownNew South WalesRekrutiert
Peter MacCallum Cancer CentreMelbourneVictoriaRekrutiert
The Alfred HospitalMelbourneVictoriaRekrutiert
Fiona Stanley HospitalMurdochWestern AustraliaRekrutiert

Austria

EinrichtungStadtBundesland oder RegionStatus
Ordensklinikum Linz GmbH ElisabethinenLinzRekrutiert
Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet WienViennaRekrutiert

Belgium

EinrichtungStadtBundesland oder RegionStatus
Jules Bordet InstitutAnderlechtRekrutiert
Universitair Ziekenhuis BrusselBrusselsRekrutiert
Local Institution - 05200GhentZurückgezogen
Uz GentGhentRekrutiert
University Hospital LeuvenLeuvenRekrutiert
Local Institution - UNK 2LeuvenZurückgezogen

Canada

EinrichtungStadtBundesland oder RegionStatus
University Of CalgaryCalgaryAlbertaRekrutiert
Local Institution - 02801HamiltonOntarioZurückgezogen
CIUSSS de l'Est-de-l'Ile-de-MontrealMontrealQuebecRekrutiert
Princess Margaret Cancer CentreTorontoOntarioRekrutiert
Local Institution - 02802VancouverBritish ColumbiaZurückgezogen

Denmark

EinrichtungStadtBundesland oder RegionStatus
Local Institution - 20003AarhusRekrutierung noch nicht begonnen
Odense University HospitalOdenseRekrutiert
Roskilde SygehusRoskildeRegion SjællandRekrutiert

Finland

EinrichtungStadtBundesland oder RegionStatus
Helsinki University Central Hospital (HUCH)HelsinkiRekrutiert
Turku University HospitalTurkuRekrutiert

France

EinrichtungStadtBundesland oder RegionStatus
Hopital Henri MondorCreteil-ParisRekrutiert
CHRU de Lille FranceLilleRekrutiert
Local Institution - 09601LyonZurückgezogen
Local Institution - 09400MarseilleAbgeschlossen
Local Institution - 09602MarseilleZurückgezogen
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de VilleneuveMontpellierRekrutiert
CHU Montpellier - Hôpital Saint EloiMontpellierRekrutiert
Chu Hotel DieuNantesRekrutiert
Hopital Saint LouisParisRekrutiert
Hôpitaux Universitaires Pitie Salpêtrière Charles FoixParisRekrutiert
Hospital Saint LouisParisRekrutiert
Local Institution - 09600ParisZurückgezogen
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Haut-LevequePessacRekrutiert
Centre Hospitalier Lyon-SudPierre-BéniteRekrutiert
CHU La MiletriePoitiersRekrutiert
Hopital SudRennesRekrutiert
Institut Universitaire du Cancer de Toulouse - OncopoleToulouseRekrutiert
Gustave RoussyVillejuifRekrutiert

Germany

EinrichtungStadtBundesland oder RegionStatus
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)BerlinRekrutiert
Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. TumorimmunoBerlinRekrutiert
Local Institution - 03155BerlinRekrutierung noch nicht begonnen
Kinikum der Universitaeat zu KoelnCologneRekrutiert
Universitatsklinikum Carl Gustav Carus an der TU DresdenDresdenRekrutiert
Local Institution - 03513DüsseldorfZurückgezogen
Universitaetsklinikum DuesseldorfDüsseldorfRekrutiert
Universitaetsklinikum EssenEssenRekrutiert
Local Institution - 03500FrankfurtZurückgezogen
Universitaetsklinikum Hamburg-EppendorfHamburgRekrutiert

172 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 18. September 2026

    Abschlussdatum nach hinten verschoben

    Primary completion delayed 2371 days

    2036-11-302043-05-29

  2. 18. September 2026

    Studienzentrum hinzugefügt

    9 sites added (222 total)

    213222

  3. 4. September 2026

    Studienzentrum hinzugefügt

    4 sites added (213 total)

    209213

  4. 30. Juli 2026

    Studienzentrum hinzugefügt

    3 sites added (209 total)

    206209

Register: ClinicalTrials.gov · NCT########

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