Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 200
Summary
- Conditions
- Neoplasms
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
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...
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.
Tracking Information
- NCT #
- NCT03435796
- Collaborators
- Not Provided
- Investigators
- Study Director: Claudia Schusterbauer, MD Celgene Corporation
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