Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-03 @ 7:37 PM
Study NCT ID:
NCT05498259
Status:
UNKNOWN
Last Update Posted:
2023-02-03
First Post:
2022-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
Study Overview
Official Title:
A Phase 2 Study of Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
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:
The purpose of this study is to evaluate the efficacy and safety of orelabrutinib combined with rituximab，followed by orelabrutinib combined with R-CHOP-like regimen for newly diagnosed untreated Non-GCB DLBCL Patients
Detailed Description:
The study will start with an initial 21-days of induction therapy with orelabrutinib and rituximab，following imaging examinations to evaluate response rates. Then treatment with 6 cycles chemoimmunotherapy (R-CHOP-like) either alone or in combination with orelabrutinib will depend on response during induction phase. Each cycle is 21 days.
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?: