Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369707
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2006-08-24
Brief Title:
Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase II Trial of Combination Bortezomib and Rituximab as Front-line Therapy for Low-grade Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer Monoclonal antibodies such as rituximab 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 bortezomib together with rituximab may kill more cancer cells
This phase II trial is studying how well giving bortezomib together with rituximab works as first-line therapy in treating patients with low-grade B-cell non-Hodgkins lymphoma
This phase II trial is studying how well giving bortezomib together with rituximab works as first-line therapy in treating patients with low-grade B-cell non-Hodgkins lymphoma
Detailed Description:
This is a multicenter prospective study
Induction therapy Patients receive bortezomib IV over 3-5 seconds on days 1 8 15 and 22 Patients also receive rituximab IV on days 1 8 15 and 22 of course 1 and on day 1 of all subsequent courses Treatment repeats every 35 days for 3 courses Patients achieving a complete response partial response or stable disease proceed to maintenance therapy
Maintenance therapy Beginning 6-8 weeks after induction therapy patients receive bortezomib IV over 3-5 seconds and rituximab IV on day 1 Treatment repeats every 60 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Blood and tissue samples are collected at baseline and periodically during study treatment
After completion of study therapy patients are followed every 3 months for 2 years
Induction therapy Patients receive bortezomib IV over 3-5 seconds on days 1 8 15 and 22 Patients also receive rituximab IV on days 1 8 15 and 22 of course 1 and on day 1 of all subsequent courses Treatment repeats every 35 days for 3 courses Patients achieving a complete response partial response or stable disease proceed to maintenance therapy
Maintenance therapy Beginning 6-8 weeks after induction therapy patients receive bortezomib IV over 3-5 seconds and rituximab IV on day 1 Treatment repeats every 60 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Blood and tissue samples are collected at baseline and periodically during study treatment
After completion of study therapy patients are followed every 3 months for 2 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STU00005335 | OTHER | Northwestern University IRB | None |