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

NCT03435796

RecruitingPhase 2, Phase 3

Sponsor: Celgene

Conditions: Neoplasms

Interventions: Gene-modified (GM) T cell therapy

Countries: United States, Australia, Austria, Belgium, Canada, Finland, France, Germany

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 overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

Not Applicable

Other protocol-defined inclusion/exclusion criteria apply
Locations (209)
  • Birmingham, Alabama, United States
  • Gilbert, Arizona, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Tucson, Arizona, United States
  • Duarte, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • San Francisco, California, United States
  • Santa Monica, California, United States
  • Stanford, California, United States
  • Aurora, Colorado, United States
  • Denver, Colorado, United States
  • New Haven, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Maywood, Illinois, United States
  • Niles, Illinois, United States
  • Indianapolis, Indiana, United States
  • Indianapolis, Indiana, United States
  • Indianapolis, Indiana, United States
  • Westwood, Kansas, United States
  • + 179 more on CT.gov