Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093769
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
2004-10-06
Brief Title:
Bortezomib and Rituximab in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of VELCADE With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-10
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:
RATIONALE Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells Giving bortezomib together with rituximab may kill more cancer cells
PURPOSE This randomized phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory non-Hodgkins lymphoma
PURPOSE This randomized phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the response rate complete response CR CR-unconfirmed CRu and partial response PR in patients with relapsed or refractory indolent B-cell non-Hodgkins lymphoma treated with bortezomib and rituximab
Secondary
Determine the response rate CR CRu and PR at the first disease response evaluation in patients treated with this regimen
Determine the overall CR rate CR and CRu in patients treated with this regimen
Determine the time to progression in patients treated with this regimen
Determine the duration of response in patients treated with this regimen
Determine the time to best response in patients treated with this regimen
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center Karnofsky performance status 70 vs 70 lactic dehydrogenase level normal vs upper limit of normal age 18 to 60 years vs 60 years and lymphoma subtype follicular vs marginal zone Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Patients also receive rituximab IV on days 1 8 and 15 of course 1 only and on day 1 of course 2 only Treatment with repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity
Arm II 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 only Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Patients in either arm may crossover to the other arm if treatment is found to be ineffective
Patients are followed at 30 days and then every 12 weeks thereafter
PROJECTED ACCRUAL A total of 24-66 patients 12-33 per treatment arm will be accrued for this study within 1 year
Primary
Determine the response rate complete response CR CR-unconfirmed CRu and partial response PR in patients with relapsed or refractory indolent B-cell non-Hodgkins lymphoma treated with bortezomib and rituximab
Secondary
Determine the response rate CR CRu and PR at the first disease response evaluation in patients treated with this regimen
Determine the overall CR rate CR and CRu in patients treated with this regimen
Determine the time to progression in patients treated with this regimen
Determine the duration of response in patients treated with this regimen
Determine the time to best response in patients treated with this regimen
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center Karnofsky performance status 70 vs 70 lactic dehydrogenase level normal vs upper limit of normal age 18 to 60 years vs 60 years and lymphoma subtype follicular vs marginal zone Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Patients also receive rituximab IV on days 1 8 and 15 of course 1 only and on day 1 of course 2 only Treatment with repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity
Arm II 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 only Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Patients in either arm may crossover to the other arm if treatment is found to be ineffective
Patients are followed at 30 days and then every 12 weeks thereafter
PROJECTED ACCRUAL A total of 24-66 patients 12-33 per treatment arm will be accrued for this study within 1 year
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 |
|---|---|---|---|
| MILLENNIUM-M34103-061 | None | None | None |
| UCLA-0401054-01 | None | None | None |