Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513234
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
Combination of Orelabrutinib and Obinutuzumab in Untreated Marginal Zone Lymphomas
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Orelabrutinib Combined With Obinutuzumab as First-line Treatment for Marginal Zone Lymphomaa Prospective Single Arm Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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 prospective single arm phase II study and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab a in untreated marginal zone lymphoma It is planned to recruit 45 patients The primary endpoint is the complete remission rate at 12 months
Detailed Description:
Marginal zone lymphomas MZL are a type of lymphoma that originates from the marginal zone tissue of the lymphoid follicles Mucosa-associated lymphoid tissue MALT and include three subtypes MALT lymphoma nodal MZL and splenic MZL For patients with marginal zone lymphoma who have indications for systemic anti-tumor treatment therapeutic options include rituximab monotherapy or more intensive immunochemotherapy regimens in combination with bendamustine chlorambucil CHOP regimen cyclophosphamide vincristine doxorubicin prednisone etc
This is a prospective phase II single-arm clinical study to initially explore the efficacy and safety of Orelabrutinib combined with obinutuzumab in patients with previously untreated marginal zone lymphoma The patients will be treated with 6 cycles of OG regimen Patients with CRPR after 6 cycles of OG treatment will be treated with 18 cycles of single-agent orelabrutinib regimen
This is a prospective phase II single-arm clinical study to initially explore the efficacy and safety of Orelabrutinib combined with obinutuzumab in patients with previously untreated marginal zone lymphoma The patients will be treated with 6 cycles of OG regimen Patients with CRPR after 6 cycles of OG treatment will be treated with 18 cycles 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