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

Official Title

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

Summary:

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.

Trial Description

Primary Outcome:

• Incidence of delayed Adverse Events (AEs)
• Persistence of GM T cells
• Analysis of vector integration sites
• Incidence of replication-competent lentiviruses
• Physical growth as assessed by physical examination (pediatric participants only)
• Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only)
• Disease status of the primary malignancy
• Disease Progression: Number of participants who continue to be responders, who have progressed, and who have relapsed will be reported.
• Disease Relapse: Number of participants who continue to be responders, who have progressed, and who have relapsed will be reported.
• Overall Survival defined as the time from the first dose of investigational product or from the randomization date to the date of death or the date the participant is last known to be alive.

• Health-related quality of life (HRQoL): Measurement of HRQoL changes as assessed using instruments administered in the parent treatment protocol

View this trial on ClinicalTrials.gov