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JOURNAL ONKOLOGIE – STUDIE

Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

Rekrutierend

NCT-Nummer:
NCT03435796

Studienbeginn:
Juni 2018

Letztes Update:
07.08.2024

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Celgene

Collaborator:
-

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

BMS Study Connect Contact Center www.BMSStudyConnect.com
Kontakt:
Phone: 855-907-3286
E-Mail: Clinical.Trials@bms.com
» Kontaktdaten anzeigen
First line of the email MUST contain the NCT# and Site #.

Studienlocations
(3 von 173)

Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. Tumorimmuno
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Bertram Glass, Site 03451
Phone: +0049551396047 00000
» Ansprechpartner anzeigen
Local Institution - 03513
40225 Dusseldorf
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Local Institution - 03500
60590 Frankfurt
(Hessen)
GermanyZurückgezogen» Google-Maps
Local Institution - 03454
48149 Muenster
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Local Institution - 03503
72076 Tuebingen
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II
97080 Würzburg
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Hermann Einsele, Site 03501
Phone: +4994120140202
» Ansprechpartner anzeigen
Local Institution - 01021
85724 Tucson
United StatesZurückgezogen» Google-Maps
Local Institution - 01206
90048 Los Angeles
United StatesZurückgezogen» Google-Maps
Local Institution - 01043
95816 Sacramento
United StatesZurückgezogen» Google-Maps
Local Institution - 01050
20007 Washington
United StatesZurückgezogen» Google-Maps
Local Institution - 01035
32804 Orlando
United StatesAbgeschlossen» Google-Maps
H. Lee Moffitt Cancer Center and Research Institute University of South Florida
33612 Tampa
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Melissa Alsina, Site 01153
Phone: 813-745-7202
» Ansprechpartner anzeigen
Local Institution - 01040
60153 Maywood
United StatesZurückgezogen» Google-Maps
Local Institution - 01063
60714 Niles
United StatesZurückgezogen» Google-Maps
Local Institution - 01020
46237 Indianapolis
United StatesAbgeschlossen» Google-Maps
Local Institution - 01026
70112 New Orleans
United StatesZurückgezogen» Google-Maps
Local Institution - 01107
02114 Boston
United StatesZurückgezogen» Google-Maps
Local Institution - 01106
02115 Boston
United StatesZurückgezogen» Google-Maps
M Health Fairview University of Minnesota Medical Center - East Bank
55455 Minneapolis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Veronika Bachanova, Site 01112
Phone: 612-625-5469
» Ansprechpartner anzeigen
Local Institution - 01030
08816 East Brunswick
United StatesAbgeschlossen» Google-Maps
Local Institution - 01053
08903 New Brunswick
United StatesZurückgezogen» Google-Maps
Local Institution - 01066
10016 New York
United StatesZurückgezogen» Google-Maps
Local Institution - 01051
14642 Rochester
United StatesZurückgezogen» Google-Maps
Local Institution - 01064
57105 Sioux Falls
United StatesZurückgezogen» Google-Maps
Local Institution - 01033
76508 Temple
United StatesZurückgezogen» Google-Maps
Local Institution - 01045
23502 Norfolk
United StatesAbgeschlossen» Google-Maps
Local Institution - 01023
23298 Richmond
United StatesZurückgezogen» Google-Maps
Local Institution - 01055
98405 Tacoma
United StatesZurückgezogen» Google-Maps
Local Institution - 02802
V5Z 1M9 Vancouver
CanadaZurückgezogen» Google-Maps
Local Institution - 02801
L8V 1C3 Hamilton
CanadaZurückgezogen» Google-Maps
Local Institution - 09400
13009 Marseille Cedex 9
FranceAbgeschlossen» Google-Maps
Local Institution - 09602
13385 Marseille Cedex 9
FranceZurückgezogen» Google-Maps
Local Institution - 13202
113-8677 Bunkyo-ku
JapanAbgeschlossen» Google-Maps
Local Institution - 13804
162-8666 Shinjuku City
JapanZurückgezogen» Google-Maps
Local Institution - 04650
1081 HV Amsterdam
NetherlandsAbgeschlossen» Google-Maps
Local Institution - 04400
3584 CS Utrecht
NetherlandsZurückgezogen» Google-Maps
Institut Clinic de Nefrologia i Urologia - Hospital Clinic i Provincial de Barcelona
8036 Barcelona
SpainRekrutierend» Google-Maps
Ansprechpartner:
Armando Lopez Guillermo, Site 08600
Phone: +34932275475
» Ansprechpartner anzeigen
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps
Ansprechpartner:
Maria-Victoria Mateos Manteca, Site 08751
» Ansprechpartner anzeigen
Local Institution - 10850
LS9 7TF Leeds
United KingdomZurückgezogen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief 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 GM T cell infusion will be asked to enroll in this

LTFU protocol upon either premature discontinuation from, or completion of the prior

parent treatment protocol.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Received at least one gene-modified (GM) T-cell infusion in a previous Celgene

sponsored or Celgene alliance partner-sponsored study, 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

Studien-Rationale

Primary outcome:

1. Incidence of delayed Adverse Events (AEs) (Time Frame - Up to 15 years from last gene-modified (GM) T cell infusion)

2. Persistence of GM T cells (Time Frame - Up to 15 years from last GM T cell infusion)

3. Analysis of vector integration sites (Time Frame - Up to 15 years from last GM T cell infusion)

4. Incidence of replication-competent lentiviruses (Time Frame - Up to 15 years from last GM T cell infusion)

5. 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. 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. Disease status of the primary malignancy (Time Frame - Up to 15 years from last GM T cell infusion)

8. Disease Progression: Number of participants who continue to be responders, who have progressed, and who have relapsed will be reported. (Time Frame - Up to 15 years from last GM T cells infusion)

9. Disease Relapse: Number of participants who continue to be responders, who have progressed, and who have relapsed will be reported. (Time Frame - Up to 15 years from last GM T cells infusion)

10. Overall Survival defined as the time from the first dose of investigational product or from the randomization date to the date of death or the date the participant is last known to be alive. (Time Frame - Up to 15 years from last GM T cells infusion)

Secondary outcome:

1. Lymphocyte count (B-cell) (Time Frame - Up to 15 years):
If B-cell recovery criteria are not met at Month 60 (Year 5), then annual monitoring will continue until B-cell recovery is confirmed on 2 consecutive analyses or up to 15 years, until subject withdrawal of consent, or death, whichever occurs first.

Geprüfte Regime

  • Gene-modified (GM) T cell therapy:
    No investigational product will be administered

Quelle: ClinicalTrials.gov


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