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

Official Title

LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH CAR T CELLS

Summary:

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Subjects who received at least one GM T cell infusion, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

Trial Description

Primary Outcome:

• Adverse Events (AEs)
• Tumour Response Status
• Disease Progression
• Disease Relapse
• Overall Survival
• Health-related quality of life (HRQoL)
• Height of pediatric subjects treated with GM T cells
• Weight of pediatric subjects treated with GM T cells
• Sexual maturation of pediatric subjects treated with GM T cells

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.

View this trial on ClinicalTrials.gov