Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846750
Status:
RECRUITING
Last Update Posted:
2023-07-19
First Post:
2023-04-27
Brief Title:
Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Marginal Zone Lymphoma
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
A Prospective Open-label Single-arm Multicenter Study to Evaluate the Efficacy and Safety of ObinutuzumabGA101 in Combination With Lenalidomide in Relapsed and RefractoryRR Marginal Zone Lymphoma MZL
Status:
RECRUITING
Status Verified Date:
2023-03
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 clinical study that will enroll 59 patients with relapsed and refractory RR MZL The study is designed to evaluate the efficacy and safety of the combination of obinutuzumab and lenalidomide in the treatment of relapsed and refractory marginal zone lymphoma MZL
Detailed Description:
Marginal zone lymphoma MZL is incurable and the vast majority of patients with MZL eventually face disease relapse or progression
There is no standard second-line treatment for relapsedrefractory MZL and the synergistic effect of obinutuzumab and lenalidomide has been demonstrated in other indolent lymphomas
The aim of this trial is to investigate the efficacy and safety of the combination of obinutuzumab GA101 and lenalidomide in the treatment of RR marginal zone lymphoma in order to find a safe and effective option for this type of disease
There is no standard second-line treatment for relapsedrefractory MZL and the synergistic effect of obinutuzumab and lenalidomide has been demonstrated in other indolent lymphomas
The aim of this trial is to investigate the efficacy and safety of the combination of obinutuzumab GA101 and lenalidomide in the treatment of RR marginal zone lymphoma in order to find a safe and effective option for this type of disease
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