Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504940
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Optimize Study - Orelabrutinib Combined With BRG in Untreated Marginal Zone Lymphoma MZL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Orelabrutinib Combined With BRG Followed by Orelabrutinib Maintenance Therapy for Newly Diagnosed Marginal Zone Lymphoma MZL A Prospective Multicenter Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-07
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 cohort study The main purpose of Cohort A is to evaluate the efficacy and safety of Orelabrutinib combined with BR bendamustine and rituximab for previously untreated young patients with MZL the purpose of Cohort B is to assess the efficacy and safety of Orelabrutinib combined with G Obinutuzumab followed by Orelabrutinib maintenance therapy for previously untreated elderly patients with MZL
Detailed Description:
Marginal Zone Lymphoma MZL is a group of B-cell malignancies believed to originate from B lymphocytes typically found in the marginal zones of lymphoid follicles in the spleen lymph nodes and mucosa-associated lymphoid tissues Currently there is no unified high-level evidence-based treatment plan for previously untreated MZL Exploring more effective low-toxicity treatment plans for MZL patients is a scientifically valuable and clinically significant attempt 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 prospective cohort clinical study for previously untreated MZL Cohort A For individuals under 70 years of age with good fitness they will receive three cycles of Orelabrutinib combined with bendamustine and rituximab BR bendamustine 70mgm2 on days 1-2 rituximab 375mgm2 on day 0 Patients achieving PR or better will enter the Orelabrutinib monotherapy maintenance phase up to 21 cycles each cycle 28 days Cohort B For individuals aged 70 or older or those under 70 years with poor fitness they will receive six cycles of Orelabrutinib combined with obinutuzumab G 1000mg iv on days 1 8 15 of cycle 1 and day 1 of cycles 2-6 Orelabrutinib 150mg once daily Patients achieving PR or better will enter the Orelabrutinib monotherapy maintenance phase up to 18 cycles each cycle 28 days
This study is a multi-center prospective cohort clinical study for previously untreated MZL Cohort A For individuals under 70 years of age with good fitness they will receive three cycles of Orelabrutinib combined with bendamustine and rituximab BR bendamustine 70mgm2 on days 1-2 rituximab 375mgm2 on day 0 Patients achieving PR or better will enter the Orelabrutinib monotherapy maintenance phase up to 21 cycles each cycle 28 days Cohort B For individuals aged 70 or older or those under 70 years with poor fitness they will receive six cycles of Orelabrutinib combined with obinutuzumab G 1000mg iv on days 1 8 15 of cycle 1 and day 1 of cycles 2-6 Orelabrutinib 150mg once daily Patients achieving PR or better will enter the Orelabrutinib monotherapy maintenance phase up to 18 cycles each cycle 28 days
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