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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03435796




Registration number
NCT03435796
Ethics application status
Date submitted
9/01/2018
Date registered
19/02/2018
Date last updated
10/06/2025

Titles & IDs
Public title
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Scientific title
Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Secondary ID [1] 0 0
U1111-1206-8250
Secondary ID [2] 0 0
GC-LTFU-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Gene-modified (GM) T cell therapy

Other: Participants exposed to Gene-modified (GM) T cell therapy -


Treatment: Other: Gene-modified (GM) T cell therapy
No investigational product will be administered
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of delayed Adverse Events (AEs)
Timepoint [1] 0 0
Up to 15 years from last gene-modified (GM) T cell infusion
Primary outcome [2] 0 0
Persistence of GM T cells
Timepoint [2] 0 0
Up to 15 years from last GM T cell infusion
Primary outcome [3] 0 0
Analysis of vector integration sites
Timepoint [3] 0 0
Up to 15 years from last GM T cell infusion
Primary outcome [4] 0 0
Incidence of replication-competent lentiviruses
Timepoint [4] 0 0
Up to 15 years from last GM T cell infusion
Primary outcome [5] 0 0
Physical growth as assessed by physical examination (pediatric participants only)
Timepoint [5] 0 0
Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached
Primary outcome [6] 0 0
Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only)
Timepoint [6] 0 0
Up to 15 years from last GM T cells infusion or until Tanner Stage 5
Primary outcome [7] 0 0
Proportion of participants who progressed on the study: participants with original diagnosis of malignancies
Timepoint [7] 0 0
Up to 15 years from last GM T cells infusion
Primary outcome [8] 0 0
Number of participants with reintroduction of standard treatments for the control of autoimmune disease activity as a surrogate for disease relapse
Timepoint [8] 0 0
Up to 15 years from last GM T cells infusion
Primary outcome [9] 0 0
Overall Survival (participants with original diagnosis of malignancies)
Timepoint [9] 0 0
Up to 15 years from last GM T cells infusion
Secondary outcome [1] 0 0
Lymphocyte count (B-cell)
Timepoint [1] 0 0
Up to 15 years

Eligibility
Key inclusion criteria
* Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not Applicable

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2036
Actual
Sample size
Target
1541
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
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Oklahoma
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United States of America
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Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
South Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
South Dakota
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Austria
State/province [35] 0 0
Wien
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Belgium
State/province [36] 0 0
Anderlecht
Country [37] 0 0
Belgium
State/province [37] 0 0
Brussel
Country [38] 0 0
Belgium
State/province [38] 0 0
Gent
Country [39] 0 0
Belgium
State/province [39] 0 0
Leuven
Country [40] 0 0
Canada
State/province [40] 0 0
Alberta
Country [41] 0 0
Canada
State/province [41] 0 0
British Columbia
Country [42] 0 0
Canada
State/province [42] 0 0
Ontario
Country [43] 0 0
Canada
State/province [43] 0 0
Quebec
Country [44] 0 0
Finland
State/province [44] 0 0
Helsinki
Country [45] 0 0
France
State/province [45] 0 0
Creteil-Paris
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France
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Lille Cedex
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France
State/province [47] 0 0
Lyon
Country [48] 0 0
France
State/province [48] 0 0
Marseille Cedex 9
Country [49] 0 0
France
State/province [49] 0 0
Montpellier CEDEX 5
Country [50] 0 0
France
State/province [50] 0 0
Nantes Cedex 01
Country [51] 0 0
France
State/province [51] 0 0
Paris
Country [52] 0 0
France
State/province [52] 0 0
Pessac
Country [53] 0 0
France
State/province [53] 0 0
Pierre-Benite CEDEX
Country [54] 0 0
France
State/province [54] 0 0
Poitiers Cedex
Country [55] 0 0
France
State/province [55] 0 0
Toulouse CEDEX 9
Country [56] 0 0
France
State/province [56] 0 0
Villejuif
Country [57] 0 0
Germany
State/province [57] 0 0
Berlin
Country [58] 0 0
Germany
State/province [58] 0 0
Dresden
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Germany
State/province [59] 0 0
Dusseldorf
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
State/province [62] 0 0
Heidelberg
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Germany
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Koeln
Country [64] 0 0
Germany
State/province [64] 0 0
Muenster
Country [65] 0 0
Germany
State/province [65] 0 0
München
Country [66] 0 0
Germany
State/province [66] 0 0
Tuebingen
Country [67] 0 0
Germany
State/province [67] 0 0
Ulm
Country [68] 0 0
Germany
State/province [68] 0 0
Würzburg
Country [69] 0 0
Italy
State/province [69] 0 0
Ancona
Country [70] 0 0
Italy
State/province [70] 0 0
Bologna
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Italy
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Milan
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Italy
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Monza
Country [73] 0 0
Italy
State/province [73] 0 0
Naples
Country [74] 0 0
Italy
State/province [74] 0 0
Roma
Country [75] 0 0
Italy
State/province [75] 0 0
Rome
Country [76] 0 0
Italy
State/province [76] 0 0
Rozzano (MI)
Country [77] 0 0
Italy
State/province [77] 0 0
Torino
Country [78] 0 0
Italy
State/province [78] 0 0
Turin
Country [79] 0 0
Japan
State/province [79] 0 0
Hokkaido
Country [80] 0 0
Japan
State/province [80] 0 0
Tokyo
Country [81] 0 0
Japan
State/province [81] 0 0
Bunkyo-ku
Country [82] 0 0
Japan
State/province [82] 0 0
Fukuoka
Country [83] 0 0
Japan
State/province [83] 0 0
Isehara City, Kanagawa
Country [84] 0 0
Japan
State/province [84] 0 0
Nagoya
Country [85] 0 0
Japan
State/province [85] 0 0
Osaka
Country [86] 0 0
Japan
State/province [86] 0 0
Shibuya-ku
Country [87] 0 0
Japan
State/province [87] 0 0
Shimotsuke
Country [88] 0 0
Japan
State/province [88] 0 0
Shinjuku City
Country [89] 0 0
Netherlands
State/province [89] 0 0
Amsterdam
Country [90] 0 0
Netherlands
State/province [90] 0 0
Rotterdam
Country [91] 0 0
Netherlands
State/province [91] 0 0
Utrecht
Country [92] 0 0
Norway
State/province [92] 0 0
Oslo
Country [93] 0 0
Romania
State/province [93] 0 0
Bucuresti
Country [94] 0 0
Spain
State/province [94] 0 0
Barcelona
Country [95] 0 0
Spain
State/province [95] 0 0
Esplugues de Llobregat
Country [96] 0 0
Spain
State/province [96] 0 0
Madrid
Country [97] 0 0
Spain
State/province [97] 0 0
Pamplona
Country [98] 0 0
Spain
State/province [98] 0 0
Salamanca
Country [99] 0 0
Spain
State/province [99] 0 0
Sevilla
Country [100] 0 0
Sweden
State/province [100] 0 0
Stockholm
Country [101] 0 0
Switzerland
State/province [101] 0 0
Bern
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Leeds
Country [103] 0 0
United Kingdom
State/province [103] 0 0
London
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Manchester Withington
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Shirley Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03435796