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

Active:	Yes
Cancer Type:	Unknown Primary	NCT ID:	NCT03435796
Trial Phases:	Phase II Phase III	Protocol IDs:	GC-LTFU-001 (primary) NCI-2018-00957 U1111-1206-8250 2017-001465-24
Eligibility:	0 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	Celgene
NCI Full Details:	http://clinicaltrials.gov/show/NCT03435796

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.

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