Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06015464
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-29
First Post:
2023-08-23
Brief Title:
An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
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:
To retrospectively collect information on DLBCL patients treated with orelabrutinib in combination with standard first-line regimens pooled analysis of the association between recent efficacy and patient characteristics including biomarkers in different types of patients to assess the predictive value of ctDNA for prognosis and subsequent therapeutic adjustments during treatment Prospective observation to collect information on the efficacy of orelabrutinib in combination with standard treatment regimens in specific types of populations with a focus on genotyped patients such as MCD BN2 and N1 subtypes to validate the predictive value of ctDNA in diagnosis and treatment Standard treatment regimens include the R-CHOP regimen and the Pola-R-CHOP regimen
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None