Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Celgene
1,541 participants
Jul 19, 2018
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria1
- Not Applicable
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Interventions
No investigational product will be administered
Locations(200)
View Full Details on ClinicalTrials.gov
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NCT03435796