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Official Title
Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Phase
Phase 2/Phase 3
Sponsor
Celgene
Enrollment
1,541
Timeline
Jul 2018 → Nov 2036
About This Study
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 Criteria
Inclusion Criteria
- 1Received 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.
- 2Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
Exclusion Criteria
- 1Not Applicable
Locations
182 sites participating in this study
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
Sagar Lonial, Site 01103
University of Alabama Birmingham
Birmingham, Alabama 10016
Luciano Costa, Site 01171
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
Rajneesh Nath, Site 01049
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →