Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415708
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-04
Brief Title:
Obinutuzumab Combined With Bendamustine in the Treatment of Mature B-cell Lymphoma
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
Obinutuzumab Combined With Bendamustine in the Treatment of Mature B-cell Lymphoma an Open-label Multicenter Study
Status:
RECRUITING
Status Verified Date:
2024-01
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 single-center single-arm clinical study to evaluate the efficacy and safety of maintenance therapy with obinutuzumab for 2 years in patients 18 years of age with newly diagnosed mature B-cell lymphoma including follicular lymphomaFL marginal zone cell lymphomaMZL waldenström macroglobulinemiaWM hairy-cell leukemia variantHCL-v who achieved PR after 6 cycles of obinutuzumab in combination with bendamustine
Detailed Description:
This study will explore whether induction therapy with obinutuzumab in combination with bendamustine followed by maintenance therapy with obinutuzumab in treatment-naïve patients with mature B-cell lymphoma will improve the prognosis of patients with this type of indolent mature B-cell lymphoma and the efficacy and safety of this regimen in different lymphoma subtypes
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