Georgia's Online Cancer Information Center

Find A Clinical Trial

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

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase II
Phase III
Eligibility
0 Years and older, Male and Female
Study Type
Other
NCT ID
NCT03435796
Protocol IDs
GC-LTFU-001 (primary)
NCI-2018-00957
U1111-1206-8250
2017-001465-24
Study Sponsor
Celgene

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

  1. 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
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.