Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290817
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-27
Brief Title:
Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
A Prospective Multicenter Single-arm Clinical Study on the Treatment of Newly Diagnosed Diffuse Large B-cell Lymphoma With High-risk of CNS Relapse Defined by CNS-IPI Using Orelabrutinib in Combination With R-CDOP Regimen
Status:
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:
None
Brief Summary:
This is a prospective multicenter single-arm clinical study on the treatment of newly diagnosed diffuse large B-cell lymphoma with high-risk of CNS relapse defined by CNS-IPI using Orelabrutinib in combination with R-CDOP regimen
Detailed Description:
Diffuse large B-cell lymphoma DLBCL is an aggressive form of B-cell lymphoma where the dual expression of Myc and BCL-2 genes in non-germinal center B-cell like non-GCB lymphomas is associated with a poor prognosis when treated with the standard R-CHOP regimen Brutons tyrosine kinase BTK a key kinase in the B-cell receptor BCR signaling pathway is an important target for the treatment of B-cell lymphomas Studies have shown that the first-generation BTK inhibitor Ibrutinib when combined with the R-CHOP regimen for previously untreated patients with dual-expressing non-GCB lymphomas can improve event-free survival rates Orelabrutinib as a new generation BTK inhibitor independently developed in China possesses higher inhibitory activity against BTK kinase and can penetrate the blood-brain barrier offering potential benefits for patients at high risk of central nervous system relapse The novel anthracycline drug-Liposomal Doxorubicin which has almost no cardiac toxicity suggests that the combination of Orelabrutinib with the R-CDOP regimen could improve the adverse prognosis of DLBCL patients at high risk of central relapse This is a prospective multicenter single-arm clinical study on the treatment of newly diagnosed diffuse large B-cell lymphoma with high-risk CNS-IPI using Orelabrutinib in combination with R-CDOP regimen All participants were treated with the Orelabrutinib combined with R-CDOP regimen The treatment cycles were set every 21 days for a total of 6-8 cycles During the study treatment period researchers conducted a tumor assessment with a 1-week time window allowed after the screening period and once again after the 4th 6th or 8th cycle of treatment to evaluate the antitumor efficacy of the investigational drug After all treatment cycles were completed follow-up visits were conducted every 3 months until the end of the 3-year period The median duration of follow-up was 24 months
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