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

RECRUITINGPhase 2/3Sponsored by Celgene
Actively Recruiting
PhasePhase 2/3
SponsorCelgene
Started2018-07-19
Est. completion2036-11-30
Eligibility
Healthy vol.Accepted
Locations97 sites

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 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.

Eligibility

Healthy volunteers accepted
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

Conditions2

CancerNeoplasms

Locations97 sites

University of Alabama Birmingham
Birmingham, Alabama, 10016
Luciano Costa, Site 01171205-934-9695
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Rajneesh Nath, Site 01049480-256-3223
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
Jeremy Larsen, Site 01200
Arizona Cancer Center
Scottsdale, Arizona, 85258
Adrienne Briggs, Site 01039520-626-3191
Local Institution - 01021
Tucson, Arizona, 85724

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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