Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003204
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2000-05-02
Brief Title:
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase III Study in Low Grade Lymphoma Comparing Maintenance Anti-CD20 Antibody Versus Observation Following Induction Therapy
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy followed by rituximab or observation in treating patients who have stage III or stage IV low-grade non-Hodgkins lymphoma Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells 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 regimen of combination chemotherapy with or without rituximab is more effective for non-Hodgkins lymphoma
Detailed Description:
PRIMARY OBJECTIVES
I To compare the response rate time to progression time to treatment failure and survival for patients with low grade lymphoma treated with the cyclophosphamide - fludarabine regimen with a control arm consisting of standard treatment with CVP
II To determine the effect of maintenance with anti-CD20 IDEC C2B8 on time to progression time to treatment failure and survival and its effects on lymphocyte number subsets and quantitative immunoglobulin levels over time
OUTLINE This a two step stratified randomized study Patients are stratified for arms I and II step 1 by age under 60 vs 60 and over tumor burden high vs low histology follicular vs other and B symptoms present vs absent After arms I and II have been completed patients are stratified in arms III and IV step 2 by extent of residual disease minimal vs gross histology follicular vs other and initial tumor burden
ARM I CLOSED AS OF 92000 Patients receive cyclophosphamide IV over 30-45 minutes on day 1 and fludarabine IV over 10-20 minutes on days 1-5 Treatment repeats every 28 days in the absence of disease progression for a minimum of 4 courses and a maximum of 6 courses
ARM II Patients receive cyclophosphamide IV over 30-45 minutes and vincristine IV on day 1 and oral prednisone on days 1-5 Treatment repeats every 21 days in the absence of disease progression for a minimum of 6 courses and a maximum of 8 courses
After completion of therapy on arm I or II patients are randomized into step 2 of this study comprising arms III and IV
ARM III Patients receive maintenance therapy with rituximab IDEC-C2B8 monoclonal antibody IV weekly for 4 weeks Courses repeat every 6 months for 2 years Maintenance therapy begins 4 weeks after the last chemotherapy
ARM IV Patients undergo no maintenance therapy and are observed
Patients are followed every 3 months for 2 years every 6 months for the next 3 years and then annually thereafter
I To compare the response rate time to progression time to treatment failure and survival for patients with low grade lymphoma treated with the cyclophosphamide - fludarabine regimen with a control arm consisting of standard treatment with CVP
II To determine the effect of maintenance with anti-CD20 IDEC C2B8 on time to progression time to treatment failure and survival and its effects on lymphocyte number subsets and quantitative immunoglobulin levels over time
OUTLINE This a two step stratified randomized study Patients are stratified for arms I and II step 1 by age under 60 vs 60 and over tumor burden high vs low histology follicular vs other and B symptoms present vs absent After arms I and II have been completed patients are stratified in arms III and IV step 2 by extent of residual disease minimal vs gross histology follicular vs other and initial tumor burden
ARM I CLOSED AS OF 92000 Patients receive cyclophosphamide IV over 30-45 minutes on day 1 and fludarabine IV over 10-20 minutes on days 1-5 Treatment repeats every 28 days in the absence of disease progression for a minimum of 4 courses and a maximum of 6 courses
ARM II Patients receive cyclophosphamide IV over 30-45 minutes and vincristine IV on day 1 and oral prednisone on days 1-5 Treatment repeats every 21 days in the absence of disease progression for a minimum of 6 courses and a maximum of 8 courses
After completion of therapy on arm I or II patients are randomized into step 2 of this study comprising arms III and IV
ARM III Patients receive maintenance therapy with rituximab IDEC-C2B8 monoclonal antibody IV weekly for 4 weeks Courses repeat every 6 months for 2 years Maintenance therapy begins 4 weeks after the last chemotherapy
ARM IV Patients undergo no maintenance therapy and are observed
Patients are followed every 3 months for 2 years every 6 months for the next 3 years and then annually thereafter
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 |
|---|---|---|---|
| CDR0000066056 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA021115 |
| E1496 | None | None | None |
| U10CA021115 | NIH | None | None |