Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
0 Years and older, Male and Female
GC-LTFU-001 (primary)
NCI-2018-00957
U1111-1206-8250
2017-001465-24
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.
Objectives
Subjects participating in this study will be followed from time of roll-over from the parent
GM T protocol until 15 years after the last GMT infusion, withdrawal of consent, lost to
follow-up, or death, whichever occurs first. Both local and central laboratory evaluations
and safety assessments will be conducted during this trial. In addition, pediatric subjects
will be monitored for growth, development and sexual maturity.
Stage 5 per Tanner Staging Criteria must be reached prior to study discontinuation.
Eligibility
- 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
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