Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06031233
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-04-24
Brief Title:
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie
Sponsor:
Isala
Organization:
Isala
Study Overview
Official Title:
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies An Observational Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
MINUTE
Brief Summary:
This study is an interventional explorative prospective study to show whether shortening of infusion times for patients using nivolumab pembrolizumab ipilimumab trastuzumab bevacizumab durvalumab or atezolizumab continues to be associated with an acceptable safety profile
Infusion times will be gradually shortened if tolerability allowes
Infusion times will be gradually shortened if tolerability allowes
Detailed Description:
After two cycles with normal infusion times infusion time will be shortened to 15 mintues en 10 minutes subsequently if no infusion reaction occurs
Patient satisfaction will be evaluated
Patient satisfaction will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None