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Recruiting Phase 2/3 NCT03435796

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

Phase 2/3 – combined trial
Conditions: Neoplasms

Sponsor: Celgene

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 18
Australia (1)
Peter MacCallum Cancer Centre
Melbourne , Victoria
Simon Harrison, Site 16001
Belgium (1)
Jules Bordet Institut
Anderlecht
Marie Vercruyssen, Site 05202
Canada (1)
University Of Calgary
Calgary , Alberta
Nizar Bahlis, Site 02302
Finland (1)
Helsinki University Central Hospital (HUCH)
Helsinki
Sirpa Leppa, Site 11551
France (1)
Hopital Henri Mondor
Creteil-Paris
Karim BELHADJ-MERZOUG, Site 09211
Germany (1)
Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. Tumorimmuno
Berlin
Bertram Glass, Site 03451
Israel (1)
Soroka Medical Center
Beersheba , Southern District
Uri Greenbaum, Site 18006
Italy (1)
Ospedali Riuniti di Ancona
Ancona
Japan (1)
Hokkaido University Hospital
Sapporo , Hokkaido
Hideki Goto, Site 13806
Netherlands (1)
Local Institution - 04650
Amsterdam
COMPLETED
Norway (1)
Oslo Universitetssykehus
Oslo
Ingerid Abrahamsen, Site 14001
Poland (1)
Uniwersyteckie Centrum Kliniczne
Gdansk
Jan Zaucha, Site 22006
Romania (1)
Institutul Clinic Fundeni
Bucharest
South Korea (1)
Asan Medical Center (AMC)
Seoul
Dok Hyun Yoon, Site 17003
Spain (1)
Hospital Universitario Vall D hebron
Barcelona
Pere Barba Suñol, Site 08451
Sweden (1)
Karolinska University Hospital Huddinge
Stockholm
Stephan Mielke, Site 15001
United Kingdom (1)
Local Institution - 10850
Leeds
WITHDRAWN
United States (1)
University of Alabama Birmingham
Birmingham , Alabama
Luciano Costa, Site 01171
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Healthy volunteers
No
Start date
19.07.2018
Completion date
30.11.2036
Registry ID
NCT03435796
Source
anzctr
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