Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03435796
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2018-01-09
Brief Title:
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-001465-24 | EUDRACT_NUMBER | WHO | None |
| U1111-1206-8250 | REGISTRY | None | None |