Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT01536067
Status:
TERMINATED
Last Update Posted:
2016-06-10
First Post:
2012-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
A Multicenter Phase II Study of Ofatumumab and Bortezomib (OB) in Previously Untreated Patients With Waldenstrom Macroglobulinemia
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding was withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well giving ofatumumab together with bortezomib works in treating patients with previously untreated Waldenstrom macroglobulinemia. Monoclonal antibodies, such as ofatumumab and bortezomib, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving ofatumumab together with bortezomib may be a better way to block cancer growth
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine overall response rate (complete response \[CR\] + partial response \[PR\] + minor response \[MR\]) of ofatumumab in combination with bortezomib.
SECONDARY OBJECTIVES:
I. Determine complete remission (CR) rate, near (n)CR rate, very good partial response (VGPR) rate and PR rate per new criteria.
II. Determine 5 year progression free survival (PFS). III. Determine time to progression and duration of response of ofatumumab in conjunction with bortezomib.
IV. Determine safety of ofatumumab in combination with bortezomib. V. Conduct laboratory correlates.
OUTLINE:
INDUCTION PHASE: Patients receive ofatumumab intravenously (IV) on days 1, 8, and 15 and bortezomib subcutaneously (SC) on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, and then every 3 months for 5 years.
I. Determine overall response rate (complete response \[CR\] + partial response \[PR\] + minor response \[MR\]) of ofatumumab in combination with bortezomib.
SECONDARY OBJECTIVES:
I. Determine complete remission (CR) rate, near (n)CR rate, very good partial response (VGPR) rate and PR rate per new criteria.
II. Determine 5 year progression free survival (PFS). III. Determine time to progression and duration of response of ofatumumab in conjunction with bortezomib.
IV. Determine safety of ofatumumab in combination with bortezomib. V. Conduct laboratory correlates.
OUTLINE:
INDUCTION PHASE: Patients receive ofatumumab intravenously (IV) on days 1, 8, and 15 and bortezomib subcutaneously (SC) on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, and then every 3 months for 5 years.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-03816 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |