Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255704
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-02-05
Brief Title:
A Single-arm Single-center Open-label Phase II Study of Zanubrutinib Combined With R-CHOPR-DHAP in Newly Diagnosed Mantle CellLymphoma Patients
Sponsor:
Shanxi Province Cancer Hospital
Organization:
Shanxi Province Cancer Hospital
Study Overview
Official Title:
A Single-arm Single-center Open-label Phase II Study of Zanubrutnib Combined With R-CHOPR-DHAP Alternating Regimen for First-line MCL and Followed by Zanubrutinib Rituximab Maintenance Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
ZRCHOPRDHAP
Brief Summary:
Evaluation the efficacy and safety of Zanubrutinib R-CHOPR-DHAP for the treatment mantle cell lymphoma
Detailed Description:
A single-arm single-center open-label phase II study of Zanubrutinib combined with R-CHOPR-DHAP alternating induction therapy followed by Zanubrutinib rituximab maintenance therapyThe primary objective of this study was to assess CR and ORR rates after 6 cycles of initiation ie at the end of induction therapy and to collect adverse events during induction and maintenance therapy
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