Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003280
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
A Randomized Phase III Trial to Determine the Effect of Consolidation With Rituximab IDEC C2B8-Mabthera in Patients With CD20 Follicular or Mantle Cell Lymphoma Having Received Induction Therapy With Rituximab Weekly x 4
Status:
COMPLETED
Status Verified Date:
2019-05
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 Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells It is not yet known which treatment regimen is more effective for lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of different regimens of rituximab in treating patients who have follicular or mantle cell lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of different regimens of rituximab in treating patients who have follicular or mantle cell lymphoma
Detailed Description:
OBJECTIVES
Assess the clinical efficacy of consolidation treatment with rituximab in terms of response rate in patients with follicular closed to accrual 91800 or mantle cell lymphoma
Compare the event free survival of patients after induction with or without consolidation
Compare the tolerability of these two treatment regimens by these patients
OUTLINE This is a randomized open label multicenter study Patients are stratified according to participating center histology follicular closed to accrual 91800 vs mantle cell status of disease de novo vs relapsed vs resistant response after induction stable disease vs partial or complete response and treatment status treated vs untreated
All patients receive induction therapy consisting of rituximab IV over 3-5 hours once a week during weeks 1-4 Patients are then randomized to one of two treatment arms
Arm I Patients are observed
Arm II Patients receive rituximab IV over 3-5 hours once a week during weeks 12 20 28 and 36
Patients are followed weekly for the first month every 8 weeks for the next 8 months then at 12 18 and 24 months and then annually for the next 3 years
PROJECTED ACCRUAL A total of 240 patients 120 per arm will be accrued for this study within 3-4 years
Assess the clinical efficacy of consolidation treatment with rituximab in terms of response rate in patients with follicular closed to accrual 91800 or mantle cell lymphoma
Compare the event free survival of patients after induction with or without consolidation
Compare the tolerability of these two treatment regimens by these patients
OUTLINE This is a randomized open label multicenter study Patients are stratified according to participating center histology follicular closed to accrual 91800 vs mantle cell status of disease de novo vs relapsed vs resistant response after induction stable disease vs partial or complete response and treatment status treated vs untreated
All patients receive induction therapy consisting of rituximab IV over 3-5 hours once a week during weeks 1-4 Patients are then randomized to one of two treatment arms
Arm I Patients are observed
Arm II Patients receive rituximab IV over 3-5 hours once a week during weeks 12 20 28 and 36
Patients are followed weekly for the first month every 8 weeks for the next 8 months then at 12 18 and 24 months and then annually for the next 3 years
PROJECTED ACCRUAL A total of 240 patients 120 per arm will be accrued for this study within 3-4 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 |
|---|---|---|---|
| EU-98009 | None | None | None |
| SWS-SAKK-3598 | None | None | None |
| ICR-3598 | None | None | None |