Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454968
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-27
Brief Title:
Orelabrutinib Combined With Obinutuzumab and Lenalidomide OGL Regimen as First-line Treatment for Marginal Zone Lymphoma
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Orelabrutinib Combined With Obinutuzumab and Lenalidomide OGL Regimen as First-line Treatment for Marginal Zone Lymphomaa Multicenter Prospective Single Arm Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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 multicenter prospective single arm phase II study and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab and lenalidomide in untreated marginal zone lymphoma The primary objective was the best complete response rate CRR
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 The incidence of MZL is second only to diffuse large B-cell lymphoma DLBCL and follicular lymphoma FL accounting for approximately 78 of all non-Hodgkin lymphomas NHL MZL is considered an indolent lymphoma with patients generally having a better overall survival prognosis Despite this some patients still face the challenges of disease relapse or transformation into large cell lymphoma leading to a poor prognosis
We conduct this prospective phase II single-arm clinical study to initially explore the efficacy and safety of Orelabrutinib combined with obinutuzumab and lenalidomide in patients with previously untreated marginal zone lymphoma The patients will be treated with 6 cycles of OGL regimen Patients with CRPR after 6 cycles of OGL treatment will be treated with 6 cycles of single-agent orelabrutinib regimen
We conduct this prospective phase II single-arm clinical study to initially explore the efficacy and safety of Orelabrutinib combined with obinutuzumab and lenalidomide in patients with previously untreated marginal zone lymphoma The patients will be treated with 6 cycles of OGL regimen Patients with CRPR after 6 cycles of OGL treatment will be treated with 6 cycles of single-agent orelabrutinib regimen
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