Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566807
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Oxygen Study-Orelabrutinib Combined With ObinutuzumabO2 for First-Line Treatment of Marginal Zone Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Oxygen Study-Orelabrutinib Combined With ObinutuzumabO2 for First-Line Treatment of Marginal Zone Lymphoma A Phase 2 Single-Arm Prospective Multicenter Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center prospective study The main purpose is to evaluate the efficacy and safety of Orelabrutinib combined with Obinutuzumab for previously untreated MZL
Detailed Description:
Marginal zone lymphoma MZL is a relatively common type of B-cell non-Hodgkin lymphoma B-NHL with an incidence rate second only to diffuse large B-cell lymphoma DLBCL and follicular lymphoma FL It is divided into three subtypes based on different clinical manifestations and pathological characteristics mucosa-associated lymphoid tissue lymphoma MALT also known as extranodal marginal zone lymphoma nodal marginal zone lymphoma NMZL and splenic marginal zone lymphoma SMZL Currently there is no unified and standardized treatment plan for newly diagnosed MZL Although high-intensity immunochemotherapy regimens have a high remission rate they also bring higher treatment-related safety risks Therefore exploring effective chemotherapy-free regimens for MZL patients is an attempt with scientific value and clinical significance With the development of new drugs new drug regimens have become prominent in the treatment of MZL and there is an increasing amount of research data on BTK inhibitors in the field of MZL The BTK inhibitor Orelabrutinib has shown good efficacy in MZL and has been approved by the NMPA for the treatment of MZL in patients who have received at least one prior treatment
This study is a multi-center prospectivet clinical study for previously untreated MZL
The patients will be treated with 6 cycles of O2 regimen Patients with CRPR after 6 cycles of O2 treatment will be treated with 1 year of single-agent orelabrutinib regimen
This study is a multi-center prospectivet clinical study for previously untreated MZL
The patients will be treated with 6 cycles of O2 regimen Patients with CRPR after 6 cycles of O2 treatment will be treated with 1 year of single-agent orelabrutinib regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None