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

  • Interventional
  • Recruiting
  • NCT03435796
Eligibility Details Visit Clinicaltrials.gov

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

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.


Age Group

Accepting Healthy Volunteers?

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

At a Glance

National Government IDNCT03435796


Lead SponsorCelgene

Lead PhysicianPeter Riedell