Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 4:06 AM
Study NCT ID:
NCT01119794
Status:
TERMINATED
Last Update Posted:
2015-08-26
First Post:
2010-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ofatumumab and Bortezomib for Patients With Low-grade B-cell Non-hodgkin Lymphoma That Relapse After Rituximab
Sponsor:
Brown University
Organization:
Study Overview
Official Title:
Ofatumumab in Combination With Bortesomib in Patients With Relapsed or Refractory Low-Grade Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to: Investigate the Overall Response Rate (ORR) of the combination of ofatumumab and bortezomib in patients with low-grade B-cell non-Hodgkin lymphoma (LG-NHL) that relapse beyond 6 months of a previous rituximab-containing regimen.
Detailed Description:
41 patients will be enrolled in this trial with low grade lymphomas and will be given Ofatumumab 1000 mg and Bortezomib IV 1.6 mg/m2 weekly times 4 treatments and will then receive maintenance treatment with the 2 agents every 2 months for 1 year unless disease progression.
Study Oversight
Has Oversight DMC:
True
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?: