Trial Details

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

NCT03435796

RECRUITING

DESCRIPTION

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.

CONDITIONS

ELIGIBILITY CRITERIA

• Inclusion Criteria
• :
• Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored 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/