Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05926427
Status:
RECRUITING
Last Update Posted:
2023-09-05
First Post:
2023-06-22
Brief Title:
Orelabrutinib Combined With Rituximab and Chemotherapy for RelapsedRefractory B-Cell Lymphoma Patients With Central Nervous System Involvement
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
Orelabrutinib Combined With Rituximab and Chemotherapy for RelapsedRefractory B-Cell Lymphoma Patients With Central Nervous System Involvement
Status:
RECRUITING
Status Verified Date:
2023-09
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:
This single-center open single-arm study aim to evaluate the efficacy and tolerability of a therapy introducing orelabrutinib on the basis of rituximab and chemotherapy in treating patients with relapsed or refractory B-cell lymphoma invloving central nervous system
Detailed Description:
Participants will receive orelabrutinib in addition to second-line therapy consisting of rituximab and recommended chemotherapy according to histopathologic type After treatment of 6 cycles with the new regimen the patients achieving CR or PR would go on to receive autologous haematopoietic stem cell transplantation auto-HSCT with or without orelabrutinib maintenance of 2 years if tolerable or orelabrutinib maintenance alone if intolerant to auto-HSCT
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