Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Overview
- Phase
- Phase 2
- Intervention
- Gene-modified (GM) T cell therapy
- Conditions
- Neoplasms
- Sponsor
- Celgene
- Enrollment
- 1541
- Locations
- 200
- Primary Endpoint
- Incidence of delayed Adverse Events (AEs)
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, 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/exclusion criteria apply
Arms & Interventions
Participants exposed to Gene-modified (GM) T cell therapy
Intervention: Gene-modified (GM) T cell therapy
Outcomes
Primary Outcomes
Incidence of delayed Adverse Events (AEs)
Time Frame: Up to 15 years from last gene-modified (GM) T cell infusion
Analysis of vector integration sites
Time Frame: Up to 15 years from last GM T cell infusion
Incidence of replication-competent lentiviruses
Time Frame: Up to 15 years from last GM T cell infusion
Physical growth as assessed by physical examination (pediatric participants only)
Time Frame: 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)
Time Frame: 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
Time Frame: Up to 15 years from last GM T cells infusion
Overall Survival (participants with original diagnosis of malignancies)
Time Frame: Up to 15 years from last GM T cells infusion
Persistence of GM T cell drug products
Time Frame: Up to 15 years from last GM T cell infusion
Secondary Outcomes
- Lymphocyte count (B-cell)(Up to 15 years)