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

Recruiting now · Phase 2/Phase 3

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT03435796

Run by

Celgene

People needed

1541

Starts

2018-07-19

Expected to finish

2036-11-30

Last updated by the study team

2026-07-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Not Applicable
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• University Of Kentucky — Lexington, Kentucky, United States (enrolling)
• Norton Cancer Institute Louisville Oncology — Louisville, Kentucky, United States (enrolling)
• Cancer Center of Kansas — Wichita, Kansas, United States (enrolling)
• University of Alabama Birmingham — Birmingham, Alabama, United States (enrolling)
• Mayo Clinic Phoenix — Phoenix, Arizona, United States (enrolling)
• University Of California San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• IN Univ Simon Cancer Center — Indianapolis, Indiana, United States (enrolling)
• Kansas University Medical Center — Westwood, Kansas, United States (enrolling)
• University of California, San Francisco- California — San Francisco, California, United States (enrolling)
• UCLA Medical Centre-Santa Monica — Santa Monica, California, United States (enrolling)
• City Of Hope — Duarte, California, United States (enrolling)
• University Of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
• The Mayo Clinic - Jacksonville, Davis-E — Jacksonville, Florida, United States (enrolling)
• Baptist Cancer Center — Miami, Florida, United States (enrolling)
• Franciscan Health Indianapolis — Indianapolis, Indiana, United States (enrolling)
• H. Lee Moffitt Cancer Center and Research Institute University of South Florida — Tampa, Florida, United States (enrolling)
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (enrolling)
• Northside Hospital, Inc — Atlanta, Georgia, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• University Of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• Stanford Cancer Center — Stanford, California, United States (enrolling)
• University of Maryland - Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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