Ignite Creation Date:
2024-05-06 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03527147
Status:
COMPLETED
Last Update Posted:
2022-08-15
First Post:
2018-04-24
Brief Title:
Platform Study for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkins Lymphoma PRISM Study
Sponsor:
Acerta Pharma BV
Organization:
Acerta Pharma BV
Study Overview
Official Title:
PRISM A Platform Protocol for the Treatment of RelapsedRefractory Aggressive Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2022-08
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:
PRISM
Brief Summary:
This is a Phase 1 platform protocol designed to evaluate various targeted agents for the treatment of relapsedrefractory aggressive Non-Hodgkins Lymphoma NHL
Detailed Description:
This is a Phase 1 platform protocol designed to evaluate various targeted agents for the treatment of relapsedrefractory aggressive Non-Hodgkins lymphoma NHL Each study arm will be conducted in a predefined disease subset All study arms are open label and allocation to each study arm will not be randomized
As this master platform protocol has multiple study arms subjects can be screened for several study arms at once Likewise a subject who ends participation in one study arm may be rescreened for participation in another separate study arm
The primary objective of the study is to evaluate the safety of targeted agents for the treatment of relapsedrefractory aggressive Non-Hodgkins Lymphoma NHL This protocol has a modular design with the potential for future treatment arms to be added via protocol amendment
As this master platform protocol has multiple study arms subjects can be screened for several study arms at once Likewise a subject who ends participation in one study arm may be rescreened for participation in another separate study arm
The primary objective of the study is to evaluate the safety of targeted agents for the treatment of relapsedrefractory aggressive Non-Hodgkins Lymphoma NHL This protocol has a modular design with the potential for future treatment arms to be added via protocol amendment
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 |
|---|---|---|---|
| 2017-004191-63 | EUDRACT_NUMBER | None | None |
| D9820C00001 | OTHER | None | None |
| LYM 138 | OTHER | Sarah Cannon Development Innovations | None |