Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508775
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-11
Brief Title:
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LONGSAFE
Brief Summary:
The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment
Detailed Description:
The focus in this trial is on the occurrence of any late adverse reactions AR serious adverse events SAE serious adverse reactions SAR and adverse events of special interest AESI ie relapse or progression of the underlying disease life-threatening infections death due to any case new and secondary malignancies lymphocyte counts detection of the transgene of the CAR T cells detection of replication-competent lentivirus RCL developmental tracking in pediatric patients and furthermore assessment of the primary status of disease progression and overall survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None