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

Condition(s) studied

Investigational drug(s) / intervention(s)

Gene-modified (GM) T cell therapy: No investigational product will be administered

Study 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 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

Primary outcome measure(s)

• Incidence of delayed Adverse Events (AEs) — Up to 15 years from last gene-modified (GM) T cell infusion
• Persistence of GM T cell drug products — Up to 15 years from last GM T cell infusion
• Analysis of vector integration sites — Up to 15 years from last GM T cell infusion
• Incidence of replication-competent lentiviruses — Up to 15 years from last GM T cell infusion
• Physical growth as assessed by physical examination (pediatric participants only) — Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached
• Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only) — Up to 15 years from last GM T cells infusion or until Tanner Stage 5
• Proportion of participants who progressed on the study: participants with original diagnosis of malignancies — Up to 15 years from last GM T cells infusion
• Overall Survival (participants with original diagnosis of malignancies) — Up to 15 years from last GM T cells infusion

Trial sites (222)

+ 182 more sites — see the full list on the official registry below.

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